BCIS literature review

December 2025

Authors: Dr. Natalia Briceno, Dr. Andrew Chapman, Dr. Richard Jabbour

 

VALVULAR HEART DISEASE

PARTNER 3: Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years

Rationale:

• There is a paucity of long-term comparative data on clinical outcomes and valve durability following transcatheter aortic-valve implantation (TAVI) versus surgical aortic-valve replacement (SAVR) among patients with severe symptomatic aortic stenosis deemed to be at low surgical risk.
• Prior analyses at 1 and 5 years have largely demonstrated similar outcomes
• This study aimed to assess 7-year outcomes, including composite clinical endpoints, valve performance, and durability which is especially important in younger lower risk patients

Publication Date:

• Leon MB et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2025 Oct 27. doi: 10.1056/NEJMoa2509766. Epub ahead of print. PMID: 41144631. October 27, 2025 (New England Journal of Medicine) DOI: 10.1056/NEJMoa2509766
• gov: NCT02675114
• Funding: Edwards Lifesciences

Study Design:

• Type: Prospective, randomized, multicenter, open-label clinical trial
• Trial: PARTNER 3
• Randomization: 1:1 to TAVI vs. SAVR
• Follow-up: 7 years
• Endpoints:
• Two primary endpoints
  • 1) non-hierarchical composite of death, stroke, or rehospitalization related to procedure/valve/heart failure
  • 2) hierarchical composite assessed by win ratio (death, disabling stroke, nondisabling stroke, rehospitalization days).
  • Clinical, echocardiographic, durability, and health-status measures were also prospectively analysed

Inclusion Criteria:

• Severe, calcific aortic stenosis
• New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%
• Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

 

Selected Exclusion Criteria:

• Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
• Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
• Evidence of an acute myocardial infarction ≤ 30 days before randomization
• Aortic valve is unicuspid, bicuspid, or non-calcified
• Severe aortic regurgitation (>3+)
• Severe mitral regurgitation (>3+) ≥ moderate stenosis
• Pre-existing mechanical or bioprosthetic valve in any position
• Complex coronary artery disease:

1. Unprotected left main coronary artery
2. Syntax score > 32
3. Heart Team assessment that optimal revascularization cannot be performed

 

Characteristics:

• Total enrolled: 1000 patients
  • TAVR group: ~503
  • SAVR group: ~497
• Average age: ~73 years
• Mean STS score: ~1.9 %

Primary Endpoint:

1. Non-hierarchical composite: death from any cause, stroke, or rehospitalization related to procedure/valve/heart failure
2. Hierarchical composite: death, disabling stroke, nondisabling stroke, and number of rehospitalization days — analyzed using a win ratio

 

Results:

Primary Endpoints at 7 Years

• First primary endpoint (Kaplan-Meier):
  • TAVI: 34.6 %
  • SAVR: 37.2 %
  • Difference: −2.6 pp (95 % CI, −9.0 to 3.7) — no significant difference
• Second primary endpoint (win ratio): 1.04 (95 % CI, 0.84–1.30) — no significant difference

Individual Components

• All-cause mortality:
  • TAVR 19.5 % vs. SAVR 16.8 %
• Stroke:
  • TAVR 8.5 % vs. SAVR 8.1 %
• Rehospitalization:
  • TAVR 20.6 % vs. SAVR 23.5 %

Additional Outcomes:

• Valve Function & Durability:
  • Mean aortic-valve gradient (7 yrs):
    • TAVI: 1 ± 8.5 mmHg
    • SAVR: 1 ± 6.3 mmHg
  • Bioprosthetic valve failure:
    • TAVI: 9 %
    • SAVR: 3 %
  • Patient-Reported Outcomes
    • Quality-of-life measures showed no significant difference between groups at 7 years follow up.

Limitations:

• Follow-up completeness: ~89 % at 7 years — late data lost to follow-up possible.
• Population: Low-risk cohort limits generalizability to moderate/high-risk or younger patients.
• Bicuspid, non-calcified valves excluded
• Some secondary outcomes with low events (e.g., pacemaker rates, paravalvular leak) were underpowered so limited conclusions can be made.
• Only performed in Sapien S3 Valves

Conclusions:

• In low-risk patients with severe, symptomatic aortic stenosis, transfemoral TAVI with a balloon-expandable valve and open SAVR demonstrated similar clinical outcomes at 7 years, with no significant differences in combined rates of death, stroke, or rehospitalization.
• Valve haemodynamics, durability (bioprosthetic failure), and patient-reported outcomes were comparable between approaches.
• These findings support the long-term viability of TAVI with the Sapien platform as an alternative to surgery in this population; however, further long-term data is awaited.

Percutaneous transcatheter valve replacement in individuals with mitral regurgitation unsuitable for surgery or transcatheter edge-to-edge repair: a prospective, multi-country, single-arm trial

Rationale

• To evaluate 1-year outcomes of a novel percutaneous transseptal transcatheter mitral valve replacement (TMVR) system in patients unsuitable for surgery or TEER.

Publication Date

Guerrero et al. Lancet. 2025; 406:2541-2550 November 29^th, 2025.

Study Design

• Prospective, multicentre, single-arm trial

Population

• Patients with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who were not suitable for surgery or transcatheter edge to edge repair from 56 centres in six countries (USA, Canada, UK, Netherlands, Israel, Australia)

Intervention

• Transcatheter mitral valve replacement using the SAPIEN M3 System (Edwards Lifesciences) under general anaesthetic with transoesophageal guidance.
• This device uses a fully retrievable nitinol dock which encircles and captures the subvalvular apparatus, creating a landing zone for the balloon expandable transcatheter heart valve.

Control

• No control arm. Evaluated against a performance goal of 45%. This was defined based on event rates from trials of TEER against medical therapy and in conjunction with the US Food and Drug Administration.

Primary Endpoint

• Non-hierarchical composite of all-cause mortality and heart failure hospitalisation at one year.

Selected secondary endpoints

• Cardiovascular mortality. Heart failure hospitalisation. Improvement in MR. Improvement in NYHA class. Stroke. Clinically significant LVOT obstruction induced by SAPIEN M3. Mitral valve re-intervention. Paravalvular leak closure. Surgical MVR. Bleeding. Major structural complications. Major access site complications. Major iatrogenic septal defects.

Funding

• Edwards Lifesciences

Trial Info

ClinicalTrials.gov, NCT04153292

Inclusion Criteria:
Patients aged 18 years or over
NYHA functional class ≥2 and core lab moderate-to-severe or severe MR
Unsuitable for surgical or commercially available transcatheter treatment based on anatomical criteria or co-morbidity
Favourable anatomical features for treatment
– healthy leaflet tissue without perforation
– LV end diastolic diameter of 35-70mm
– commissure-commissure distance of <45mm
– absence of features associated with high risk of PVL, LVOT obstruction or difficulty implanting the dock or transcatheter heart valve

Anatomical suitability was determined using transthoracic and transoesophageal echocardiography and cardiac CT. Eligibility was confirmed by an independent physician screening committee.

Selected Exclusion Criteria:
– LV end diastolic diameter >75mm
– mitral annular or leaflet calcification that would interfere with device
– increased risk of PVL
– severe LV or RV dysfunction
– high risk of LVOT obstruction

Results:
A total of 1,171 patients were screened.

846 patients failed screening (410 anatomical exclusion, 280 inclusion criteria failed, 156 clinical exclusion)

299 patients treated (with 287 valves implanted; 96%). In 5 patients there were encircling difficulties, 5 had a low dock position, 1 had a pre-existing mobile echodensity and in 1 patient medial commissural access was not possible.

Primary Composite Outcome:
All-cause death or heart failure hospitalisation occurred in 25.2% (95%CI 20.6-30.6) at one-year, P<0.0001 vs performance goal

Additional Outcomes:
No difference between primary versus secondary MR
No patients required a second valve or conversion to surgery.
No intraprocedural deaths. Two in-hospital deaths and four in-hospital stroke events.

30-day outcomes:
Stroke (2.7%)
MV re-intervention (2.3%)
PVL closure (1.7%)
Clinically significant valve thrombosis (2.3%)
Haemolysis (4.3%)
New onset AF (7.9%)
Permanent pacemaker (2.6%)

1-year outcomes:
Stroke (2.7%)
MV re-intervention (2.3%)
PVL closure (1.7%)
Clinically significant valve thrombosis (2.3%)
Haemolysis (4.3%)
New onset AF (7.9%)
Permanent pacemaker (2.6%)
Sustained reduction in MR (grade 1 or lower) (96%)

Limitations:
1. Single arm study with no contemporary medical therapy control arm
2. Performance goal (45% primary endpoint) defined based on secondary MR patients in two prior RCTs of TEER therapy
3. Case selection bias with numerous exclusion criteria- findings reflect performance in optimal patient group selected with greatest likelihood of benefit
4. Only have outcomes to 1-year, however, inoperable patient cohort not suitable for TEER therapy therefore results are encouraging.
5. Risks of survival bias in symptom-based endpoints.
6. Performance in centres of expertise and real-world performance may differ

Conclusions

• Percutaneous treatment of moderate-to-severe or severe MR unsuitable for surgery or TEER is feasible and safe, with a low rate of death and heart failure re-hospitalisation at 1 year.

 

 

 

CORONARY ARTERY DISEASE

β Blockers after Myocardial Infarction with Mildly Reduced Ejection Fraction: An Individual Patient Data Meta-Analysis of Randomised Controlled Trials

Rationale:

• Evidence for the benefit of β-blocker therapy after acute myocardial infarction (MI) is well established in patients with reduced left ventricular ejection fraction (LVEF < 40 %).
• However, the benefit in patients with mildly reduced LVEF (40–49 %) but without heart failure remained uncertain because individual trials were underpowered for this subgroup.
• This study aimed to clarify whether β-blocker therapy reduces major adverse outcomes in this specific population.

Publication Date:

• Rosselló et al. β blockers after myocardial infarction with mildly reduced ejection fraction: an individual patient data meta-analysis of randomised controlled trials. The Lancet; 406(10508), September 13, 2025, Pages 1128–1137
  DOI: 10.1016/S0140-6736(25)01592-2

Study Design:

• Type: Individual patient-data meta-analysis
• Data Source: Four recent randomized controlled trials
  • REBOOT
  • BETAMI
  • DANBLOCK
  • CAPITAL-RCT
• Population: Patients with acute MI (randomisation within 14days), LVEF 40–49 %, and no prior history or clinical signs of heart failure
• Intervention: β-blocker therapy versus no β-blocker therapy
• Model: One-stage fixed-effects Cox proportional hazards regression
• Primary Endpoint: Composite of all-cause death, new MI, or heart failure
• All endpoints independently adjudicated

Trial Info:

• Includes patients from multiple international RCTs that randomized MI patients within 14 days to receive β-blockers versus control
• Meta-analysis registered on PROSPERO (CRD420251023480)

Inclusion Criteria:

• Recent acute myocardial infarction
• Left ventricular ejection fraction (LVEF) 40–49 %
• Randomisation to β-blocker or control within 14 days post-MI
• No history or clinical signs of heart failure

Selected Exclusion Criteria:

• Prior clinical heart failure or signs thereof
• Contraindications to β-blocker therapy

Characteristics:

• Total patients analysed: 1,885
  • β-blocker group: 991 patients (53 %)
  • Control group (no β-blocker): 894 patients (47 %)
• Trials included (patients with mildly reduced EF):
  • REBOOT: 979
  • BETAMI: 422
  • DANBLOCK: 430
  • CAPITAL-RCT: 54

Primary Endpoint:

• Composite of:
  • All-cause death
  • New myocardial infarction
  • Heart failure

Measured as events per 1,000 patient-years and hazard ratios via Cox regression.

Results:

Primary Composite Outcome

• β-blocker group: 106 events
  • Rate: 32.6 per 1,000 patient-years
• Control group: 129 events
  • Rate: 43.0 per 1,000 patient-years
• Hazard Ratio (HR): 0.75 (95 % CI 0.58–0.97); p = 0.031
• No heterogeneity: trial-by-treatment pinteraction = 0.95; country pinteraction = 0.98

This indicates a 25 % relative reduction in the risk of the primary composite outcome with β-blocker therapy.

Additional Outcomes:

• Consistent Directionality:
  • Individual components (all-cause death, recurrent MI, heart failure) trended lower with β-blockers
• Heterogeneity:
  • No significant differences between trials or across countries — indicating consistent effect across settings.

Limitations:

• Population: Focused only on patients without overt heart failure and mildly reduced EF; does not address preserved EF (≥50 %) or those with prior heart failure history.
• Median follow-up across included trials was >1 year
• Trial Differences: As an IPD meta-analysis pooling several trials, variations in β-blocker type, dosing, and other management may exist.
• In 3 trials (REBOOT, BETAMI, and DANBLOCK), they were pragmatically designed in nature, and therefore the categorisation of LVEF was based on data reported by the enrolling centres, which might have resulted EF misclassification
• All trials were open label which could introduce bias

Conclusions:

• In patients with acute myocardial infarction and mildly reduced LVEF (40–49 %) without heart failure, β-blocker therapy was associated with a statistically significant 25 % reduction in the composite endpoint of all-cause death, new MI, or heart failure compared with no β-blocker therapy.
• This outcome extends the recognised benefit of β-blockers from patients with reduced LVEF (<40 %) into this mildly reduced EF subgroup and supports continued use of β-blocker therapy in this population.
• This paper nicely complements another recent meta-analysis of 5 RCTs (1) with a total of 17,801 patients (REBOOT (7459 patients), REDUCE-AMI (4967 patients), BETAMI (2441 patients), DANBLOCK (2277 patients), and CAPITAL-RCT (657 patients) trials) with normal EF post MI which did not reduce the incidence of death from any cause, myocardial infarction, or heart failure in patients with an LVEF of at least 50% after myocardial infarction without other indications for beta-blockers.
  • During a median follow-up of 3.6 years, a primary-end-point event occurred in 717 patients (8.1%) in the beta-blocker group and 748 patients (8.3%) in the no-beta-blocker group (hazard ratio, 0.97; P = 0.54).
  • All-cause mortality: 335 patients (beta-blocker group) and 326 patients (no-beta-blocker) (hazard ratio, 1.04; 95% CI, 0.89 to 1.21)
  • Myocardial infarction: 360 (beta-blocker group) and 407 patients (hazard ratio, 0.89; 95% CI, 0.77 to 1.03)
  • Heart failure: 75 (beta-blocker) and 87 patients (hazard ratio, 0.87; 95% CI, 0.64 to 1.19).

• Kristensen AMD, et al. Beta-Blockers after Myocardial Infarction with Normal Ejection Fraction. N Engl J Med. 2025 Nov 9. doi: 10.1056/NEJMoa2512686. Epub ahead of print. PMID: 41211954.

Stratified treatment of myocardial infarction with non-obstructive coronary arteries: the PROMISE trial

Rationale: To determine if stratified treatment for myocardial infarction with non-obstructive coronary arteries improves clinical outcomes as compared to standard care

Publication Date: Montone RA et al. Eur Heart J. 2025. https://doi.org/10.1093/eurheartj/ehaf917

Study Design:

• Type: Multi-centre randomised controlled trial (1:1)
• Population: Patients with MINOCA
• Intervention: Comprehensive diagnostic work up to identify the underlying aetiology and target treatment
• Comparator: Standard care defined by the treating clinician
• Primary Endpoint: Between group difference in the change in angina status at 12-months assessed by Seattle Angina Questionnaire
• Secondary Endpoint: MACE (all-cause mortality, MI, stroke, HF hospitalisation and repeat angiography).
• All endpoints independently adjudicated

Trial Info:

Inclusion Criteria:
1. Myocardial infarction according to the Fourth Universal Definition criteria
2. No obstructive coronary artery disease (no stenosis >50%)

Selected Exclusion Criteria:
1. Contraindication to CMRI
2. End-stage renal or hepatic disease
3. Co-morbidity with life-expectancy of <1 year
4. Presence of non-cardiac or cardiac non-coronary causes of MI
5. Takotsubo cardiomyopathy
6. Clear aetiology of MINOCA evident at baseline angiography

Procedures:
Randomisation performed immediately after invasive angiography
CMRI performed in 80% of stratified treatment group and 75% of standard care

OCT performed in 43/45 (95.5%) of stratified treatment group
Acetylcholine provocation in 37/45 (82%) of stratified treatment group
Echocardiography in 3/45 (7%) of stratified treatment group

OCT and ACh not permitted in the standard care arm.

Results:

Primary Outcome:
At 12-months, SAQSS was significantly higher in the stratified treatment group vs standard care group (+9.38 (6.81 to 11.95, P<0.001).

Additional Outcomes:
Stratified investigation led to identification of cause of MINOCA in 80%.

Strengths:
– Demonstrating the feasibility of recruitment and randomisation of MINOCA patients in a multi-centre randomised trial is helpful
– Very detailed phenotyping with clear evidence of use of adjunctive diagnostic testing

Limitations:
– Small trial of 100 patients
– Unblinded treatment intervention with high risk of bias
– Early termination due to recommendation of the Data Safety and Monitoring Board – Primary outcome in favour of treatment but this was symptom based with no placebo control
– A very limited change in overall medical therapy received between treatment arms (the only significant difference being in the administration of non-dihydropyridine calcium channel blockers (33% [15/45] vs 2% [1/47]).

Conclusions:
Stratified treatment based on comprehensive diagnostic assessment and aetiology-guided therapy led to an improvement in angina-related health status in this small unblinded trial, but only a small difference in overall treatment was observed.

iModern: Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction

Rationale

• To investigate whether immediate iFR guided PCI of non-culprit lesions in patients presenting with STEMI and multi vessel coronary disease is superior to a deferred cardiac stress perfusion MRI guided approach.

Publications details:

• Nijveldt et al; iMODERN Investigators. Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction. N Engl J Med. 2025 Oct 28. doi: 10.1056/NEJMoa2512918. Epub ahead of print. PMID: 41159879.

Study design

• International, investigator initiated.
• Prospective open label randomised controlled superiority trial.
• 1:1 randomization of patients presenting with STEMI to undergo immediate iFR guided PCI of non-culprit lesions (defined as lesions with >50% stenosis and iFR less than or equal to 0.89) or deferred cardiac stress MRI guided PCI within 6 weeks after randomization.

Trial Information

• 1146 patients (558 in immediate iFR group and 588 in deferred MRI group)
• 41 sites
• Industry supported.
• COVID pandemic resulted in a pause to recruitment.
• Recruitment commenced in December 2017 and was complete in February 2022
• In the iFR arm, all non-culprit vessels were interrogated with iFR that had a diameter stenosis >50%. In those with a diameter stenosis of greater than 90%, PCI without iFR was allowed. PCI performed in all non-culprit lesions with an iFR of 0.89 or below. PCI of non-culprit could be performed within 24 hours.
• In the MRI arm, MRI performed within 6 weeks and angiogram and MRI images were analysed in a core laboratory for the adjudication of perfusion defects. A deferred iFR guided PCI procedure was allowed as a bail out.
• During trial recruitment there was lower than anticipated event rates, therefore follow up was increased to 3 years.
• Follow up 3, 6 and 12 months, and then at 3 years (middle 3 time points in person)

Inclusion

• 18 years or older
• Presenting as STEMI having undergone successful primary PCI of culprit artery
• PCI within 12 hours of symptom onset
• One or more non culprit lesions in a non-infarct related artery with a diameter stenosis greater than 50%

Exclusion

• Prior STEMI
• Chronic total occlusion
• Complex non culprit lesions
• Greater than 50% left main stenosis
• Cardiogenic shock
• Haemodynamic instability
• Acute pulmonary oedema

Outcomes

• Primary end point: composite of death from any cause, recurrent myocardial infarction or hospitalization for heart failure at 3 year follow-up.
• Secondary end points:
  • Individual components of primary endpoint at 6 and 12 months
  • Cardiac death
  • Stroke
  • Transient ischaemic attack
  • Major bleeding
  • Unstable angina
  • Unplanned angiography and revascularization
  • Stent thrombosis

Results:

• Mean age 63 ±11 years
• 78% male in both arms
• Smoking rates higher in iFR group
• Majority of patients in both arms had normal or mild LV dysfunction
• Baseline angiographic variables well balanced
• 1 in ten patients in the MRI group did not undergo an MRI and underwent iFR guided bailout procedure at a median of 34 days
• 8% of patients had a non culprit lesion with ischaemia in the MRI group, versus 44.9% of patients in the iFR arm
• 6% of patients in iFR group and 18.7% of patients in the MRI group underwent non culprit lesion coronary artery PCI.
• Primary end point occurred in 9.3% in the iFR group and 9.8% in the MRI group (hazard ratio, 0.95; 95% confidence interval [CI], 0.65 to 1.40, p=0.81)
• Death from any cause or recurrent myocardial infarction did not differ
• Secondary end points similar between groups no difference in adverse events.
• Stent thrombosis was numerically higher in iFR group but was not statistically significant.

Conclusions:

• In patients presenting with STEMI and multivessel coronary artery disease, immediate iFR guided PCI was not superior to a deferred cardiac stress perfusion MRI guided PCI strategy for non culprit lesions.

Limitations:

• Event rate was lower than expected even at 3 years so study may not be powered sufficiently to detect differences in the primary outcome.
• iFR may have been impacted by alterations in microvascular resistance at the time of STEMI, potentially leading to some false positives
• In the MRI group some patients did not undergo additional ischaemia testing or intervention which may also have influenced the trial findings

 

Comments:

• One fifth of patients in the MRI group did not undergo MRI stress perfusion, of which half underwent bail out iFR guided PCI.
• iFR identified more positive lesions than cardiac stress perfusion MRI and therefore smaller ischaemic territories may have been missed on MRI. Despite this there remained to be no difference in outcomes.
• The number of primary endpoints was lower than predicted so further adequately powered trials need to be performed.
• Although not adequately powered, this trial showed that a deferred strategy is safe in patients presenting with STEMI with multi vessel disease, and equally there is no increase in adverse events or PCI complications in those patients undergoing multi vessel PCI at the time of STEMI.

PROCTOR: PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery

Rationale

• Current guidelines recommend PCI of the native coronary artery instead of the failed vein graft, however this is based on observational data. There are challenges with both approaches: vein graft PCI has a high risk of no reflow and early stent failure and native vessel PCI often involves extensive atheroma and high rates of CTO given the aggressive nature of post bypass native coronary artery disease. The aim of this trial was to compare the outcomes of native vessel PCI versus SVG PCI in post CABG patients.

Publications details:

• de Winter RW et al. PROCTOR Trial Investigators. PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial. J Am Coll Cardiol. 2025 Oct 28:S0735-1097(25)09477-X. doi: 10.1016/j.jacc.2025.09.1577. Epub ahead of print. PMID: 41159978

Study design

• International open label, randomised controlled trial
• 1:1 randomisation of patients with a heart team defined indication for percutaneous revascularisation to undergo PCI to the vein graft or PCI to the native vessel.
• Successful PCI defined as residual stenosis less than 30% with restoration of TIMI 3 flow in distal vascular bed of the bypassed native vessel.
• If initial PCI strategy failed, second attempt was performed or cross over to the alternative strategy.
• Intention to treat analysis
• 1, 3 and 5 year follow up planned

Trial Information

• 341 patients screened, 220 patients randomised
• 14 centres in Europe
• Initial sample size 584 patients
• Follow up during index hospitalization and one year clinical outcomes were assessed through national registry databases, longitudinal review of electronic medical records and telephone interviews
• Recruitment between December 2018 and December 2023

Inclusion

• 18 years or older
• Significant diameter stenosis (>50%) in an SVG in invasive coronary angiography
• Revascularisation clinically indicated by local heart team
• Both SVG and native vessel were technically treatable via PCI.

Exclusion

• Cardiogenic shock
• STEMI
• Ongoing ischaemia in setting of NSTEMI
• Estimated life expectancy of less than 3 years
• Unfavourable angiographic characteristics: target vessel diameter <2.5mm, graft diameter >5.5mm, marked aneurysmal degeneration of the bypass graft, heavy thrombus burden
• Early graft failure

Outcomes

• Primary outcome: major adverse cardiovascular events (MACE): composite of all cause mortality, non fatal target coronary territory MI or clinically driven target coronary revascularisation. PCI related MI occurring during index procedure was included.
• Target vessel failure
• Target lesion revascularisation
• Renal failure requiring RRT
• Patient reported quality of life

Results:

• 220 patient randomly assigned to undergo native PCI (n=108) or SVG PCI (n=112)
• 10 patients had died within 1 year of index procedure.
• Mean age 73 ± 7, 84% male
• Mean time between CABG and index PCI was 18± 8 years
• Baseline characteristics well balanced
• Out of the 112 in the SVG PCI group, 3 crossed over to native vessel PCI. Out of 108 patients in the native vessel PCI group, 12 crossed over to SVG PCI.
• 1/5^th of patients had prior target SVG PCI
• Numerically higher numbers of ACS in native vessel PCI group
• Target lesion in the native PCI group was a CTO in 83% of patients
• Patients in native PCI group had higher numbers of stents implanted (7 ± 1.3 vs 1.3 ± 0.8; P< 0.001), longer total stent length (p<0.001), fluoroscopy time (p<0.001) and contrast volume (p<0.001)
• In native vessel PCI group, initial procedure not successful in 17%, of which 11% if these crossed over, and those 7 remaining only 2 had successful PCI of native vessel.
• In SVG PCI group 10% were not successful, of which 3% had PCI of native vessel and 7% managed conservatively.
• Final technical success similar in both groups, above 90%.
• J CTO score in both groups were 2, with half of patients had retrograde dissection re-entry as crossing technique
• At 1 year follow up, composite end point occurred in 34% of patients in the native PCI group and 19% of patients in SVG OPCI group (HR: 2.14; 95% CI: 1.25-3.65; P =006)
• No difference in mortality
• Difference driven by non fatal target coronary territory MI and also PCI related MI
• Similar differences seen in the as treated analysis.
• No interaction observed between treatment effect and age, sex, diabetes, presence of native vessel CTO and clinical presentation with ACS

Conclusions:

• In patients post CABG with an indication for revascularisation, a strategy of PCI to the SVG was associated with lower MACE as compared with a native vessel PCI approach.

Limitations:

• Small patient numbers due to early termination
• Slow recruitment (3 patients per centre per year) with a risk of selection bias
• Lack of power most important when interpreting secondary end points
• Decisions regarding repeat revascularisation were down to the treating physician.
• Noa medical therapy arm included.

Comments:

• First randomised controlled trial asking this important question.
• The results of this trial go against the widely held belief that native vessel PCI is preferable to SVG PCI.
• Whilst a heart team was involved in ensuring technical feasibility of both arms in this trial, a high proportion of patients in the native vessel PCI arm had native vessel CTOs classified as difficult with more than 50% requiring a retrograde approach. Therefore, procedural complexity was higher, with longer stents, increased fluoroscopy time and contrast volume in the native PCI group. This may have led to higher PCI related MI.
• Graft occlusion post native vessel PCI was not routinely performed, and this competitive flow may have also played a role in the increase in events seen in the native CI group.
• MACE rates were higher in the native vessel PCI group as compared to other CTO trials, which in part may be reflective of the post CABG population which are often of higher risk due to their co-morbidities and complexity of disease.
• Recruitment was slow (average 3 patients per centre per year), and so the trial was terminated before the total number of patients were recruited. This means that the secondary end points should be interpreted with a caution.
• One year may be too short to assess for outcomes post SVG PCI, and it will be interesting to see if the SVG PCI arm catches up with the native PCI in terms of adverse outcomes with longer term follow up.
• Currently with the current evidence base, decisions regarding whether to PCI an SVG or native vessel should be assessed on a case by case basis, taking into account factors such as lesion complexity and the presence of prior SVG graft failure.
• There were higher numerical rates of stabilised ACS in the native PCI group and low use of embolic protection in SVG group, to suggest these patients overall may have been in a lower risk category.

BCIS has petitioned the DVLA strongly over the last two years (under Dan Blackman’s watchful eye) regarding recent changes in fitness to drive guidance. We are very pleased to say that the DVLA guidance has now been changed for the better Assessing fitness to drive – a guide for medical professionals (pages 81-82).

Firstly, for patients with aortic stenosis but without symptoms of syncope, presyncope or symptoms that you feel would impact on safe driving, the patient may drive and does not need to notify the DVLA. This will make a big difference to a lot of patients, but is not yet widely known or understood.

Secondly, for patients who have had a TAVI, the statutory period off driving is now only 2 weeks. This is also an excellent change.

BCIS literature review

August 2025

Authors: Dr. Natalia Briceno, Dr. Andrew Chapman, Dr. Richard Jabbour

VALVULAR HEART DISEASE

DAPA TAVI

Dapagliflozin After Transcatheter Aortic Valve Implantation

 

Rationale

• Patients who undergo TAVI are at increased risk of heart failure admission post‑procedure.
• SGLT‑2 inhibitors improve outcomes in patients with heart failure.
• The trial aimed to test whether adding dapagliflozin post‑TAVI could reduce HF events and mortality

Publication date

• Raposeiras-Roubin Set al; DapaTAVI Investigators. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Apr 10;392(14):1396-1405.
• gov number: NCT04696185

Study design

• Multicentre Spanish RCT
• Independent
• Pragmatic, open‑label, blinded endpoint adjudication
• 39 Spanish Centres between January 2021 and December 2023.

Trial info

• Population: Elderly patients (median age ~82 years, ~49% women) with severe aortic stenosis undergoing TAVI, and a history of HF hospitalization.
• Sample size:
• 1,222 patients in primary analysis: 1:1 randomisation dapagliflozin versus standard of care
• 605 dapagliflozin vs 617 standard care

Inclusion criteria

• Severe aortic stenosis undergoing TAVI
• Prior HF admission and one of the following:
  • Left ventricular ejection fraction ≤ 40% or
  • Diabetes mellitus or
  • Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2

Exclusion Criteria:

• Known allergy or intolerance to SGLT2 inhibitors.
• Concomitant therapy with sulfonylurea or SGLT2 inhibitors.
• Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
• An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
• Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
• Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
• Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
• Pregnant or breast-feeding patients
• Patients participating in other clinical trials.

Primary endpoint

• The primary outcome was a composite of all-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).

Results

• Primary outcome: Occurred in 15.0% of the dapagliflozin group vs 20.1% in control (HR 0.72; P = 0.02)
• Worsening HF component: 9.4% vs 14.4% (HR, 0.63; 95% CI, 0.45 to 0.88)
• All‑cause mortality: 7.8% vs 8.9% (HR, 0.87; 95% CI, 0.59 to 1.28) [not statistically significant]
• Other secondary outcomes (e.g. cardiovascular death or HF hospitalization) also trended favourably but were generally non-significant individually

 

Limitations

• Conducted exclusively in Spain – may affect generalizability
• Open‑label design could introduce bias even though the endpoints were adjudicated blindly
• Majority of benefit driven by HF events rather than all-cause mortality
• Approximately 20% discontinued dapagliflozin by one year due to known side effects of SGLT2 inhibitors

Conclusions

• In elderly post‑TAVI patients with prior heart failure and additional comorbidity, adding dapagliflozin 10 mg daily resulted in a 28% reduction in the composite of death or HF worsening at 1 year
• This was driven primarily by fewer HF events
• Treatment proved generally safe, though hypotension and genital infections were more frequent.
• These findings support consideration of SGLT‑2 inhibitors as adjunct medical therapy in this population.

 

VALVULAR HEART DISEASE

EVOLUT LOW RISK 5 YEAR OUTCOMES

Rationale

• To determine whether the supra‑annular, self-expanding Evolut TAVR system (CoreValve/Evolut R/Evolut PRO) maintains safety and efficacy compared to surgical aortic valve replacement (SAVR) up to five years in patients with severe aortic stenosis determined to below surgical risk (defined as: STS‑PROM score < 3%)

Publication date

• Forrest JK, et al; Low Risk Trial Investigators. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2025 Apr 22;85(15):1523-1532.
• Clinical Trgov: NCT02701283

Study Design

Trial info

• A prospective, international, randomized, multicentre trial comparing Evolut TAVR versus SAVR in low-risk patients.
• Valve types evolved over time (CoreValve, Evolut R, Evolut PRO)
• Follow-up extended through 5 years
• Low‑surgical‑risk (STS-PROM < 3%) patients with severe symptomatic aortic stenosis; mean age ~74 years; ~35% female
• 86 centres across U.S., Canada, Europe, Japan, Australia, New Zealand
• 1,414 randomized; 730 TAVI, 684 SAVR.
• 5 years follow up available for ~91% TAVI vs 87% SAVR patients (~671 TAVR, 598 SAVR)

Inclusion criteria

• Severe symptomatic aortic stenosis
• Estimated low surgical risk (< 3% 30-day mortality by STS score)
• Heart Team–determined suitability for both TAVI and SAVR

Selected exclusion criteria

• Patients with severe comorbidities
• Anatomical contraindications to TAVR
• Life expectancy < 1 year

Primary endpoint

Composite of all-cause mortality or disabling stroke at 5 years

Results

• Five‑year composite endpoint (primary):
  • 5% (TAVI) vs 16.4% (SAVR), P = 0.47
• All‑cause mortality:
  • 5% (TAVI) vs 14.9% (SAVR), P = 0.39
• Disabling stroke:
  • 6% (TAVI) vs 4.0% (SAVR); P = 0.57
• Cardiovascular mortality:
  • 2% (TAVI) vs 9.3% (SAVR), P = 0.15
• Non‑cardiovascular mortality:
  • 8% (TAVI) vs 6.2% (SAVR), P = 0.73
• Valve performance:
  • TAVI had significantly lower mean gradients: 10.7mmHg (TAVI) vs 12.8 mmHg (SAVR), P < 0.001
  • In addition, larger effective orifice areas 2.1 (TAVI) vs 1.9 cm² (SAVR), P < 0.001
• Paravalvular regurgitation (PVL):
  • Mild or greater PVL higher after TAVI (~17.0%) vs SAVR (~5.7%), P<0.001
• Reintervention rates:
  • 3% (TAVI) vs 2.5% (SAVR), P = 0.44
• Quality of life:
  • KCCQ scores 88.3% (TAVI) vs 88.5 (SAVR)
• PPM rates:
  • 27% (TAVI) vs 13% (SAVR), P <0.001

Comments

• Loss to follow‑up higher in control arm (~9% TAVR, ~13% SAVR) may bias long-term data; however, analysis with withdrawn patients excluded changed all-cause mortality rates to 14.7% vs 15.2%, P = 0.74 (Still non-significant)
• Mild+ PVL was higher after TAVI, without clear clinical impact
• Implantation techniques have improved over time with lower pacemaker rates in contemporary TAVI implants with the cusp overlap technique
• Longer-term (beyond five years) valve durability and structural integrity—in low-risk, younger populations—remain to be fully established with 10‑year follow-up and is eagerly awaited

Conclusions

• At five years, in low-surgical-risk patients with severe aortic stenosis, the Evolut TAVI system showed comparable outcomes to surgery for the primary composite endpoint of all‑cause mortality or disabling stroke.
• TAVI demonstrated favourable hemodynamic, sustained quality-of-life benefits, and no significant increase in reinterventions, with an increase in PVL and PPM rates but overall low rates of valve failure.
• These data support TAVI as a durable and effective alternative to surgery in low-risk patients over intermediate-term follow‑up

 

VALVULAR HEART DISEASE

BHF PROTECT TAVI TRIAL

 

Rationale

• To determine the effectiveness of a cerebral embolic protection (CEP) device in the reduction of acute stroke in patients with severe aortic stenosis who were undergoing transcatheter aortic valve implantation (TAVI).

Publication date

• Kharbanda RK on behalf of the BHF PROTECT-TAVI Investigators. Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation. N Engl J Med 2025;392:2403-2412.
• Registered at ISRCTN16665769

Study Design

Trial information

• A prospective multi-centre randomised controlled trial at 33 sites across the United Kingdom
• Pragmatic design aiming to recruit an all-comers population
• Parallel group randomisation – CEP device versus no CEP device
• Device: Sentinel CEP (Boston Scientific) deployed via the right radial artery with filters covering the left common carotid artery and the right innominate artery.
• 7,635 patients randomised: 3,815 CEP and 3,820 no CEP
• Stroke ascertainment by the Questionnaire to Verify Stroke Free Status (QVSFS) in addition to routine clinical review

Inclusion criteria

• Severe aortic stenosis scheduled for TAVI (via any access route where cerebral embolic protection (CEP) may be used).
• Clinically and anatomically suitable for Sentinel CEP (as per treating clinician)
• Aged 18 years or above
• Willing and able to give informed consent

 

Selected exclusion criteria

• No specific exclusion criteria

Primary outcome

• The incidence of stroke at 72-hours post-TAVI (or hospital discharge if sooner)

Results

• Similar baseline and procedural characteristics in the intervention and control arms
• Transfemoral TAVI in 99.3 versus 99.4%
• Valve in valve in 3.8% versus 3.2%
• Balloon-expandable valve used in 57.4 versus 57.3%
• Procedure duration 62 mins (48 to 81) versus 52 mins (39 to 70 mins)
• The primary endpoint occurred in 2.1% (81/3,795) in the CEP group and 2.2% (82/3,799) in the control group [difference -0.02%, 95%CI -0.68 to 0.63; P=0.94].
• There was no difference in secondary outcomes including
  • Disabling stroke at 6-8 weeks (-0.2%, 95%CI -0.7 to 0.4)
  • Severe stroke within 72 hours or before discharge (0.0%, 95%CI -0.3 to 0.3)
  • Death within 72 hours or before discharge (0.1%, 95%CI -0.3 to 0.5)
  • Death or stroke within 72 hours or before discharge (0.1%, 95%CI -0.6 to 0.8)
  • Death, stroke or TIA within 72 hours or before discharge (0.2%, 95%CI -0.6 to 1.0)
• There were no major adverse safety signals from device use
  • Access site complications occurred before hospital discharge occurred in 8.1% (304/3,772) in the CEP group and 7.7% (290/3,776) in the control group (difference 0.4%, 95%CI -0.8 to 1.6).
  • Access site complications after discharge within 6 to 8 weeks occurred in 0.8% (27/3,347) in the CEP group and 0.4% (13/3,378) patients in the control group (difference 0.4%, 95%CI 0.1 to 0.8).

Comments

• Large, multi-centre, pragmatic trial across 33 sites in the United Kingdom.
• Event rate consistent with population level estimates from UK TAVI registry
• Population representative of routine practice
• No evidence of learning effect in centres with less familiarity with CEP
• There was some interruption due to COVID-19 and there was limited diversity

Conclusions

• Routine use of CEP was not associated with a reduction in incident stroke within 72 hours or prior to discharge from hospital after TAVI. This robust assessment of this device therapy is consistent with prior trial data and suggests routine CEP does not have a role in elective TAVI.

CORONARY ARTERY DISEASE

RIVAWAR

Rationale:

• To investigate the efficacy of the direct oral anticoagulant rivaroxaban as compared with warfarin in patients with acute LV thrombus at 12 weeks, to guide anticoagulant therapy in this population.

 

Publications details:

• Shah JA, Hussain J, Ahmed B, Batra MK, Ali G, Naz M, Khan W, Bhatti KI, Karim M, Hakeem A. Rivaroxaban vs Warfarin in Acute Left Ventricular Thrombus Following Myocardial Infarction: RIVAWAR, An Open-Label RCT. JACC Adv. 2025 Jul 23;4(8):101978. doi: 10.1016/j.jacadv.2025.101978. Epub ahead of print. PMID: 40706143; PMCID: PMC12309278.

 

Study design:

• Open label, non inferiority, parallel-group randomised control trial
• Investigator initiated
• Participants randomised 2:1 to receive rivaroxaban (20mg) or warfarin (target INR 2-3) for 12 weeks

 

Trial Information:

• 261 patients randomised, 171 in the rivaroxaban group and 90 in warfarin group
• Conducted in the National Institute of Cardiovascular Disease in Pakistan, which is a large volume (>10,000 yearly PPCI) centre
• Recruitment from June 7 2021 to December 31 2023
• Patients treated with warfarin or rivaroxaban alongside standard DAPT consisting of aspirin and clopidogrel
• Intervention period included 4 weeks of triple therapy, followed by single antiplatelet with clopidogrel alongside allocated anticoagulant for the remaining 8 weeks.
• Patients started on GDMT for LV dysfunction
• Follow up: weekly telephone consultations, with in person visit every 2 to 4 weeks. Follow up echo at 4 and 12 weeks.
• Resolution of thrombus defined as no visualisation of LVT on apical 4 chamber, 2 chamber, 3 chamber and 4 chamber off axis views on 2D echo.
• Bleeding events monitored alongside MACE
• Per protocol analysis
• No crossovers

 

Inclusion:

• Confirmed diagnosis of STEMI or NSTEACS
• Detected LVT on echocardiography within 7 days of acute MI

 

Exclusion:

• Refusal to consent
• Cardiogenic shock at time of LV thrombus diagnosis
• Prior major or intracranial bleeding
• Advanced CKD (eGFR <30mL/min)
• Other indications for anticoagulation

 

Outcomes:

• Primary end point: Complete resolution of left ventricular thrombus assessed by echocardiography at 12 weeks
• Secondary outcomes all cause mortality, stroke and bleeding events

 

Results:

• 314 screened with acute LVT and 216 met inclusion criteria. 171 randomized to rivaroxaban and 90 were randomized to warfarin group.
• Baseline characteristics similar, with age, sex and type of MI matched.
• Majority of patients presenting with STEMI and having severe LVSD
• Mean age 54.5 +/- 10.7 years
• PCI performed in 85.1% of patients
• Median INR 2.4 in those on warfarin
• At 4 weeks, 20% of patients in rivaroxaban arm and 8.3% in the warfarin arm had complete resolution of LVT. P-value for non inferiority = 0.017. No difference at 12 weeks.
• Safety outcomes and all cause mortality not statistically different between groups
• Rates of ischaemic stroke numerically higher in rivaroxaban group than warfarin, but not statistically significant.
• Major bleeding in 2.3% in rivaroxaban cohort and 1.1% in warfarin cohort
• 2 intracranial bleeds in rivaroxaban and none in warfarin cohort.

 

Conclusions:

• Rivaroxaban has been shown to be non-inferior to warfarin in treatment of acute LVT
• There is evidence to suggest that rivaroxaban leads to a quicker resolution, with a higher percentage of patients having resolution of thrombus at 4 weeks
• Numerically although not statistically significant more bleeding events and ischaemic strokes, which is comparable to previous DOAC trials, with no difference in all cause mortality.

 

Limitations:

• 2:1 randomization imbalance
• Single centre
• Short follow up

 

Comments:

• Higher rates of thrombus resolution compared to other studies, however only enrolled acute MI and less sensitive modality used to assess thrombus.
• Due to 2:1 randomisation design, smaller warfarin cohort with wider CI
• 4 weeks of triple therapy may have had an impact on safety outcomes especially in those with higher risk of bleeding, now ESC advise one week of triple therapy.

Further studies needed to investigate the safety signal with larger numbers, with more sensitive imaging modalities used alongside evaluation of treatment duration.

CORONARY ARTERY DISEASE

Pressure derived indices in the left main coronary artery

 

Rationale:

• The left main coronary artery subtends a large area of myocardium and is prognostically important, and historically its assessment has been based on anatomical diameter stenosis. There is low use of invasive physiology for assessment of left main disease, and paucity of data on how best to assess.
• Authors sought to investigate whether invasive pressure based indices are similar in both the left anterior descending artery and left circumflex in patients with isolated left main coronary artery disease, and whether any differences are as a result of differences in microvascular function in the territories they supply.

 

Publications details:

• Demir OM, Sinha A, Rahman H, Ryan M, O’Gallagher K, Ellis H, Li Kam Wa M, Saraf S, Alfakih K, Webb I, Melikian N, De Silva K, Chiribiri A, Plein S, Perera D. Pressure-Derived Indices in the Left Main Coronary Artery: Insights From Comprehensive In Vivo Hemodynamic Studies of Diseased and Unobstructed Vessels. Circ Cardiovasc Interv. 2025 Jul;18(7):e015320

Study design:

• Prospective observational
• Invasive coronary physiology study
• Investigator initiated

 

Study Information:

• Conducted at St Thomas’ Hospital and Kings College Hospital, campuses of Kings College London
• Patients enrolled if they had an indication for an invasive coronary angiogram or percutaneous coronary intervention.
• Cardiac catheterization protocol
  • Right radial artery access
  • 1mg of midazolam and 70 units per kg of heparin
  • 400-600 mg of isosorbide dinitrite into left coronary artery
  • Indices measured using Verrata Plus Volcano 0.014-inch coronary wire
  • Paired LAD and LCx coronary physiological measurements obtained
  • Indices: In all patients FFR, iFR and manual pullback. In a subset of patients, coronary flow was measured using a dual doppler/pressure sensing guidewire (Combowire).
  • Resting measurements and measurements during hyperaemia induced by IV adenosine in both main daughter branches were obtained.
• Coronary flow velocity reserve defined as the ratio of hyperemic to resting average peak velocity.
• Microvascular resistance reserve calculated as CFvR dived by FFR, multiplied by basal aortic pressure dived by hyperaemic aortic pressure. Metric that characterises the vasodilator reserve capacity of the coronary microcirculation, while accounting for the influence of epicardial disease and impact of giving potent vasodilators to the aortic pressure.
• Hyperaemic microvascular resistance was calculated as distal coronary pressure divided by flow velocity during maximal hyperaemia.
• Sensitivity analyses performed, investigating potential effect of hydrostatic forces (using CTCA), the relationship between myocardial mass and MRR (cardiac MRI) and also pressure wire derived indices by anatomic location of LMCA stenoses.

 

Inclusion:

• Clinical indication for invasive coronary angiogram or PCI
• Isolated LMCA cohort
  • Atheroma angiographically and physiologically isolated to the LMCA (FFR pullback gradient £05 FFR units in both LAD and LCx
  • LMCA lesion contributed to ³80% of the total FFR in each vessel.
• Unobstructed cohort
  • Angiographically normal vessels
  • FFR >0.80 in both limbs
  • Normal microvascular function (LAD CFvR³0)

Exclusion:

• LVEF <50%
• ACS within 4 weeks
• Greater than mild valve disease
• Resting HR >120bpm
• Prior CABG
• Contraindication or intolerance to adenosine or contrast

 

Results:

• 80 patients enrolled (47 in LMCA cohort and 33 in unobstructed cohort)
• All patients in unobstructed cohort underwent dual pressure and Doppler assessment. 22 patients in LMCA cohort underwent dual pressure and Doppler coronary assessment.
• Patients in unobstructed group were younger and more likely to be female
• In patients with isolated LMCA disease, FFR in LAD 0.74±11 and in LCx 0.81±0.11 (p<0.0001). iFR values lower in LAD versus LCx also (0.89 versus 0.94).
• On pressure wire pullback, the pressure drop was higher between LAD and left main than between LCx and left main.
• Similar differences in the unobstructed cohort were observed with respect to resting and hyperaemic pressure based indices
• Rate of misclassification of functional significance if using only the LCx was 1 in 5 patients when using FFR and higher (28% of patients) when using iFR. All misclassification related to a significant LMCA lesion being judged as non significant.
• Within cohort -MRR values higher in LAD than in the LCx in both cohorts, minimal hyperaemic MR was also lower in LAD than in LCx, and maximal coronary flow and CFvR were higher in LAD in both cohorts
• Between cohort- MRR in LAD was similar in LAD in both unobstructed and LMCA patients. This was seen in LCx also.
• Myocardial mass and MRR were correlated.

 

Conclusions:

• Pressure wire derived physiological indices have been shown to be lower in the LAD as compared with the LCx in both patients with LMCA and those with unobstructed coronaries.
• Minimal microvascular resistance was also lower in the LAD (therefore higher CFvR in LAD) in both LMCA and unobstructed cohorts.
• These findings suggest that thresholds for diagnosing haemodynamically significant epicardial and microvascular dysfunction may be different in different vessels.

 

Limitations:

• Small number of patients studied
• Intracoronary imaging not performed and so patients with downstream atheroma not apparent on angiogram may have been included, alongside patients with LMCA that extends beyond the left main
• No outcome data obtained

 

Comments:

• Regardless of the presence of epicardial disease, pressure derived indices differ between the LAD and LCx, which was shown to be due to differences in coronary flow and microvascular resistance. This led to a 1 in 5 misclassification of the severity of LMCA if using solely LCx to assess functional significance.
• This supports prioritizing physiological assessment of the LAD in assessing isolated LMCA. It also has implications for the thresholds used for assessing functional significance of other bifurcations.
• There is a need for further research on physiological assessment of bifurcations including non-left main alongside evaluation of vessel specific thresholds.

 

CORONARY ARTERY DISEASE

SMART CHOICE

 

Rationale

• To define the optimal strategy for long-term antiplatelet maintenance in those who have previously underwent percutaneous coronary intervention (PCI), comparing the efficacy and safety of aspirin and clopidogrel.

Publication date

• Hong Choi et al. Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular events after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial. Lancet 2025;405:1252-1263
• Registered at gov(NCT04418479)

 

Study Design

Trial information

• Prospective, investigator-initiated, multicentre, prospective, randomised open-label trial comparing clopidogrel and aspirin monotherapy in 26 sites in South Korea.
• 5,506 patients randomly allocated to clopidogrel or aspirin monotherapy
• Median time between PCI and randomisation was 17.5 months (IQR 12.6-36.1)
• Median follow up 2.3 years (IQR 1.6-3.0)

Inclusion criteria

• 19 years or older
• Successful PCI with drug eluting stent
• Standard duration DAPT (≥12 months for MI and ≥6 months for any other PCI)
• No cardiovascular events after PCI

 

At least one complex coronary lesion:

-True bifurcation lesion (>2.5mm)

-Chronic total occlusion

-Unprotected left main disease

-Long lesion >38mm

-Multivessel PCI

-Multiple stents
-In-stent restenosis
-Severely calcified lesions
-Ostial lesions of major epicardial artery

Or
-At high risk of recurrent ischaemic event

-Previous MI

-Medication treated diabetes

Selected exclusion criteria

-Long-term treatment with oral anticoagulants

-Use of DAPT for any other indication than coronary disease

-Use of single antiplatelet at screening

-Contraindication to aspirin or clopidogrel

Primary outcome

• Cumulative incidence of death from any cause, myocardial infarction or stroke

Results

• Primary outcome: 4.4% (clopidogrel) vs 6.6% (aspirin) [hazard ratio 0.71, 95% CI 0.54 – 0.93, P=0.013].
• Death occurred in 2.4% (95% CI 1.6 – 3.1%) in the clopidogrel group and 4.0% (95% CI 2.9 – 5.0%) in the aspirin group (HR 0.71, 95%CI 0.49 – 1.02)
• Myocardial infarction occurred in 1.0% (95% CI 0.6 – 1.4%) in the clopidogrel group and 2.2% (95% CI 1.4 – 2.9%) in the aspirin group (HR 0.54, 95% CI 0.33 – 0.90)
• Stroke occurred in 1.3% (95% CI 0.7 – 2.0%) in the clopidogrel group and 1.3% (0.8 – 1.7%) in the aspirin group (HR 0.79, 95% CI 0.46 – 1.36)
• There was no increase in bleeding, which occurred in 3.0in the clopidogrel group and 3.0% in the aspirin group (HR 0.97, 95% CI 0.67-1.42).

Comments

• There is some uncertainty about the generalisability of this trial. Very few women were recruited (18.2%) and it exclusively recruited Korean participants but no difference in results when stratified by CYP2C19 allele
• Open label design – risk of bias in prescribing of gastroprotective therapies may have minimised bleeding effects
• Event rate was lower than anticipated
• Low rate of patients with high bleeding risk
• Results may not apply to these patients nor those with CKD
• No prespecified antiplatelet strategy in patients who had further PCI or anticoagulant therapy commenced.
• Median DAPT duration was long at 17.5 months prior to randomisation, which may have allowed selection of those patients at high bleeding risk to declare themselves, biasing results.

Conclusions

• In patients at high risk of ischaemic events following PCI, clopidogrel monotherapy was associated with a lower rate of death, myocardial infarction or stroke. The generalisability of these findings is limited to select populations and the results should be considered in the context of other evidence which supports a long term P2Y12 monotherapy strategy.

 

Evidence-based recommendations on intravascular lithotripsy to treat calcified coronary arteries during percutaneous coronary intervention. This involves using ultrasound shockwaves to break up hard deposits in the arteries, to allow blood to flow more freely.

LSA guidance evaluates categories of technologies that are already in widespread use within the NHS. It assesses whether price variations between technologies in a category are justified by differences in innovation, clinical effectiveness and patient benefits. This will support NHS commissioners, procurement teams and healthcare professionals to choose technologies that maximise clinical effectiveness and value for money.

BCIS are pleased to announce that the new PCI guidelines have now been published in ICR3 and can be accessed using the following link: PCI in the UK: Recommendations of the BCIS | ICR Journal. A great deal of work, involving many cardiologists, has gone into producing this document. We hope these updated guidelines will be a useful reference for hospitals across the country. PCI in the UK has been one of the success stories of the NHS and we hope these updated guidelines provide an updated  framework for safe and effective coronary intervention.

Best Wishes,

Gerald Clesham, Hon Sec

 

 

BCIS literature review

March 2025

Authors: Dr. Richard Jabbour, Dr. Claudia Cosgrove, Dr. Natalia Briceno

VALVULAR HEART DISEASE

 

EARLY TAVR

Treatment of severe aortic stenosis without symptoms

 

Rationale:

• The purpose of the study was to determine whether transcatheter aortic valve implantation (versus routine clinical monitoring) was beneficial in patients with severe asymptomatic aortic stenosis (stage C aortic stenosis).

 

Publication date:

• gov number, NCT03042104
• Généreux P, et al; EARLY TAVR Trial Investigators. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025 Jan 16;392(3):217-227.

 

Study Design

• International
• Randomized 1:1
• Parallel
• Open label
• A total of 901 patients underwent randomization; 455 patients were assigned to TAVI and 446 to clinical surveillance.

 

Trial Info:

• 901 Patients included (1578 screened)
• Duration of follow-up: median 3.8 years
• Mean patient age: 75.8 years
• Median STS 1.8%
• 6% low surgical risk
• 30% female
• TAVI valve used: balloon expandable (SAPIEN 3 / SAPIEN 3 ultra)

Inclusion criteria:

• 65 years of age or older
• Severe aortic stenosis
• Patient asymptomatic (negative ETT or physician assessment if unable to perform stress test).
• LV ejection fraction ≥ 50%
• Society of Thoracic Surgeons (STS) risk score ≤ 10

 

Selected exclusion criteria:

• Patient is symptomatic
• Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
• Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
• Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
• Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR
• Evidence of an acute myocardial infarction ≤ 30 days before randomization
• Aortic valve is unicuspid, bicuspid with unfavourable features for TAVR, or is non-calcified
• Severe aortic regurgitation (>3+)
• Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis
• Pre-existing mechanical or bioprosthetic valve in any position
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Inability to tolerate or condition precluding treatment with anti-thrombotic therapy
• Stroke or transient ischemic attack within 90 days of randomization
• Renal insufficiency and/or renal replacement therapy
• Active bacterial endocarditis within 180 days of randomization
• Severe lung disease or currently on home oxygen
• Severe pulmonary hypertension
• History of cirrhosis or any active liver disease
• Significant frailty as determined by the Heart Team
• Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
• BMI >50 kg/m2
• Estimated life expectancy <24 months

 

Primary Endpoint:

Major adverse cardiac events: All-cause death, all stroke, and unplanned cardiovascular hospitalization at 2 years

 

Results:

• Primary end-point event: 122 patients (26.8%) in the TAVI group vs 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; CI 0.40 to 0.63; P<0.001).
• All cause death: 8.4% TAVI vs 9.2% clinical surveillance (not significant)
• Stroke: 4.2% TAVI vs 6.7% clinical surveillance (not significant)
• Unplanned hospitalization for cardiovascular causes: 20.9% TAVI vs 41.7% clinical surveillance (HR 0.43; CI, 0.33-0.55)
• During a median follow-up of 3.8 years, 87% of patients in the clinical surveillance group underwent aortic-valve replacement.
• There were no differences in procedure-related adverse events between patients in the TAVI group and those in the clinical surveillance group who underwent aortic-valve replacement. No patients in either group died of CV causes within 30 days.
• Stroke incidence at 30 days: 0.9% TAVI vs 1.8% control group (converted to aortic valve replacement)

 

Limitations

• Unblinded trial driven by endpoint susceptible to bias
• No surgical arm in trial
• In real world practice ETT is often difficult to adopt in practice due to severe AS
• 87% of patients underwent TAVI in the control arm making it difficult to ascertain a true comparison between groups

 

Conclusions

• Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVI was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes.
• The endpoint of the trial was driven by unplanned TAVR, a component which would be susceptible to bias in this unblinded trial
• Two surgical trials – RECOVERY and AVATAR also found early SAVR were beneficial, but these trials contained relatively small numbers of patients and were therefore underpowered to detect true differences between groups in hard endpoints.
• Notably, 87% of patients effectively received an aortic valve replacement in the clinical surveillance arm
• In young patients with asymptomatic severe AS, the issues regarding long term durability and risks of long-term PPM insertion remain
• There were no differences in death or stroke between groups which indicates that current practice may not change significantly based on these results.

 

TAVR UNLOAD

Treatment of moderate aortic stenosis without symptoms

Rationale:

• The purpose of the study was to explore whether transcatheter aortic valve implantation (SAPIEN 3 THV) was beneficial (compared with clinical surveillance / guideline-directed medical therapy) in patients with moderate stage B aortic stenosis and chronic systolic heart failure.

 

Publication date:

• gov number:NCT02661451
• Van Mieghem NM et al. Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD.J Am Coll Cardiol. 2024 Oct 22:S0735-1097(24)09960-1

 

Study Design

• Randomized, open label
• Parallel
• Investigator initiated
• International
• Enrolment period Jan 2017 – Dec 2022

 

Trial Information

178 Patients with chronic systolic heart failure and moderate aortic stenosis (stage B aortic stenosis) were randomized to TAVI with a balloon-expandable valve (n = 89) vs. clinical surveillance (n = 89).

• Total number of patients: 178
• Duration of follow-up: 23 months
• Mean patient age: 77 years
• Percentage female: 21%
• 6% NYHA III/IV
• Mean aortic valve area (baseline or dobutamine stress): 1.2 cm²in the TAVI group vs. 1.3 cm² in the clinical surveillance group
• Mean aortic valve gradient (baseline or dobutamine stress): 21.9 mmHg in the TAVI group vs. 21.9 mmHg in the clinical surveillance group

 

Inclusion criteria:

• Left ventricular (LV) ejection fraction (EF) < 50% at rest on appropriate guideline-directed medical therapy
• Heart Failure with NYHA class ≥ 2
• Moderate aortic stenosis (typically mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg at rest and aortic valve area (AVA) > 1.0 cm2 and ≤1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) at rest)
• Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV

 

Exclusion criteria

• LVEF < 20% or persistent need for intravenous inotropic support
• Hospitalization for acute decompensated HF within 2 weeks prior to randomization
• Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization
• Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization
• In need and suitable for revascularization per heart team consensus
• Severe aortic and/or mitral regurgitation
• Congenital unicuspid or congenital bicuspid aortic valve
• Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA)
• Previous aortic valve replacement (mechanical or bioprosthetic)
• Severe RV dysfunction
• Previous stroke with permanent disability (modified Rankin score ≥ 2)
• Severe lung disease as indicated by FEV1 <30% predicted or need for chronic daytime supplemental oxygen therapy
• Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or need for renal replacement therapy
• Gastrointestinal (GI) bleeding within the past 3 months
• Liver cirrhosis Child-Pugh C
• Active systemic infection, including active endocarditis

Primary endpoint

• The primary endpoint was the hierarchical occurrence (win ratio) of:
• all-cause death
• disabling stroke
• disease-related hospitalizations and heart failure equivalents
• change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analysed using the win ratio.

Results:

• At the longest follow-up, TAVI resulted in 47.6%-win pairs vs. 36.6% in the clinical surveillance group (p = 0.14).
• At 1-year follow-up, TAVR resulted in 48.0%-win pairs vs. 30.9% in the clinical surveillance group (p = 0.032). This was driven by QoL: Mean change in KCCQ at 1 year: 12.8 in the TAVI group vs. 3.2 in the clinical surveillance group (p = 0.018)
• At the longest follow-up, mean change in KCCQ: 10.9 in the TAVR group vs. 6.1 in the clinical surveillance group (p = 0.20)
• No patients died in TAVI group at 30 days, 1 (1.1%) disabling stroke).
• In the clinical surveillance group, 43% underwent TAVI at a median of 12 months (q1-q3 6-20months). 92% had progression to severe AS.

 

Limitations

• Small number of patients
• Underpowered to detected difference in treatment groups
• Trial stopped early due to issues with recruitment / funding
• Lack of sham control may have influenced the quality-of-life findings
• Study only performed with balloon-expandable (Sapien) valve

 

Conclusion:

•   TAVI was not superior to clinical surveillance with guideline directed medical therapy for the primary hierarchical composite endpoint in patients with moderate AS and heart failure with reduced ejection fraction at a median follow up of 23 months
• Performing TAVI in moderate aortic stenosis was however safe and may lead to improvements in quality of life
• When analysis was restricted to 1 year of follow-up, TAVI was associated with an improvement in the composite of clinical events and quality of life. This was driven by QoL with an improvement in KCCQ compared with clinical surveillance.
• The trial was relatively small and underpowered to detect a difference in hard endpoints between groups
• In the clinical surveillance group, 43% underwent TAVI at a median of 12 months. 92% had progression to severe AS.
• Further data is eagerly awaited: For example, the PROGRESS (NCT04889872) and EXPAND II (NCT05149755) trials are exploring the efficacy of TAVI (balloon-expandable and self-expanding devices) in patients with moderate AS.

 

CORONARY ARTERY DISEASE

 

DCB-BIF trial 

DCB use in side branches

Rationale:

• The aim of the trial was to evaluate whether a strategy of treating a pinched side branch during provisional stenting with a drug coated balloon improves outcomes as compared with a non-compliant balloon, in patients with simple, true coronary bifurcations.

 

Publication:

• Gao, X, Tian, N, Kan, J. et al. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial. JACC. 2025 Jan, 85 (1) 1–15. https://doi.org/10.1016/j.jacc.2024.08.067

 

Study Design

• International (22 centres; China, Italy, Indonesia, Republic of Korea)
• Randomized 1:1 stratified by diabetes, initial presentations and sites.
• Treatment allocation masked to all except for physician and staff in the cardiac catheterization laboratory.

 

Trial Information

• 784 patients included (1231 screened)
• Duration of follow-up: 12 months
• Paclitaxel coated balloon used
• Mean patient age: 65 years
• 3% female
• 6% had diabetes
• 1% had Median 1,1,1 bifurcation lesions
• Crossover from 1 stent to 2 stent strategy occurred in 3.3% of the DCB arm and 3.8% in the NCB group.
• Distal left mains made up 15.2% of cases enrolled.

 

Procedure:

• Provisional stenting according to the EBC recommendations
• SB pre dilatation not recommended
• Stenting of MV was followed by proximal optimisation technique (POT)
• Randomisation in cases where ostial SB diameter stenosis ≥70%
• In DCB group, 1:1 non-compliant balloon NCB) used to dilate ostium, with sufficient predilatation defined as less than or equal to 50% residual stenosis. Then DCB inflated for 60 seconds. Following DCB, kissing balloon inflation performed with 2 NCBs and re POT performed. Indications for SB rescue stenting included Type C dissection or TIMI flow grad less than 3.
• In NCB group, all steps the same except that a DCB was not used.

 

Inclusion criteria:

• Patients aged 18 or over
• Presentation with silent ischaemia, stable or unstable angina or acute myocardial infarction older than one week from onset of chest pain to admission.
• Target lesion simple and true bifurcation (Median 1,1,1; Medina 1,0,1; Medina 0,1,1). With reference vessel diameter greater than or equal to 2.5mm, baseline diameter stenosis greater than or equal to 50%, side branch lesion length less than 10mm, successful recanalization of CTO in other MV or SB before enrolment, ostial SB stenosis greater than or equal to 70% after stenting MV.

 

Selected exclusion criteria:

• Allergy to study balloon, stent or protocol required concomitant medications
• Intolerance to DAPT
• Life expectancy less than 12 months
• Pregnancy or breast feeding
• Re stenotic lesion
• Severe calcification requiring rotational atherectomy
• Haemodynamic instability.

 

Primary Endpoint:

• Major adverse cardiac events at 12 months following the procedure, encompassing cardiac death, target vessel MI or clinically driven target-lesion revascularisation.

 

Results:

• Baseline characteristics well matched between groups.
• Luminal gain was slightly higher in SB in the DCB arm (p=0.041) as assessed by quantitative coronary analysis.
• Kissing balloon inflation after dilating SB was performed in fewer patients in NCB arm (p=0.001).
• Complete revascularisation was achieved in a similar proportion of patients in both arms.
• QFR post MV stenting was significant in side branch, which improved following treatment to side branch.
• Primary end point: Occurred in 49 patients in NCB group as compared with 28 patients in DCB group (Kaplan-Meier rate: 12.5% vs 7.2%; HR: 0.56;95% CI: 0.35-0.88; P= 0.013).
• Risk of spontaneous MI higher in NCB group (p=0.029) leading to a higher rate of target vessel MI in NCB group (p=0.009).
• No difference in secondary outcomes of al cause death, cardiac death, periprocedural MI, MACE without periprocedural MI, clinically driven TLR or stent thrombosis.

 

Limitations 

• Treatment allocation unblinded to the operators
• Results may not be applicable to sirolimus coated balloons.
• Overall low rates of patients presenting with myocardial infarction, so may not be able to extrapolate results to this group of patients
• Complex bifurcation lesions and those with calcium were excluded
• Overall comparable but low rates of intra coronary imaging use
• Lower rate of KBI in NCB group
• Females underrepresented.

 

Conclusions

• First randomised trail evaluating the use of DCBs for treating side branch stenoses following MV stenting in true bifurcation lesions.
• Combination of main vessel stenting and DCB treatment to the side branch led to fewer MACE at 12 months, driven by fewer target vessel myocardial infarctions.
• No difference in cardiac death, all cause death, or stent thrombosis were observed.
• Results consistent with smaller PEPCAD-V study.
• No reduction in target lesion revascularisation, suggesting the observed increase in myocardial infarctions may not have been deemed clinically significant to warrant re study or revascularisation.

  

 

The CLEAR trial: Colchcine in Acute Myocardial Infarction 

Rationale:

• There has been a lot on interest in anti-inflammatory therapeutics in coronary artery disease, given the role that inflammation is thought to have in the development of atherosclerosis. Given prior conflicting data, the aim of this study was to evaluate the effects of colchicine in patients following a myocardial infarction.

 

Publication:

• Jolly et al; CLEAR Investigators. Colchicine in Acute Myocardial Infarction. N Engl J Med. 2025 Feb 13;392(7):633-642.

 

Study Design

• International multicentre RCT
• Prospective
• Double blind
• 2 by 2 factorial design
• Patients randomly assigned to receive either colchicine or placebo and spironolactone or placebo in a 1:1:1:1 allocation. Results of the spironolactone arm are reported elsewhere.
• Randomisation stratified according to trial centre and type of myocardial infarction.
• Time to event analyses were performed

 

Trial Information

• 7062 patients enrolled (across 104 centres in 14 countries)
• 3528 patients assigned to receive colchicine, 3534 to receive placebo.
• Median follow up 3 years
• Mean age 61 years
• 20% females enrolled
• 9% had previous MI, 10% had prior PCI
• 5% had diabetes
• 1% presented with STEMI, 4.9% had NSTEMI
• C reactive protein levels and safety also assessed
• Trial drugs colchicine 0.5mg, spironolactone 25mg and placebo
• Initially weight-based dosage of colchicine, but swapped to once a day give higher than average discontinuation
• 9% of patients in colchicine group discontinued the trial regimen

 

Inclusion criteria:

• STEMI who underwent PCI or NSTEMI who had undergone PCI and had one or more of the following risk factors: an LVEF no more than 45%, diabetes mellitus, multi vessel coronary artery disease, prior MI or age greater than 60
• Patients enrolled within 72 hours of PCI

 

Selected exclusion criteria:

• Age ≤18years
• Pregnancy or breastfeeding
• Hypotension
• Diarrhoea
• Allergy to everolimus
• Unable to take DAPT

 

Primary Endpoint:

• Primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke or unplanned ischaemia driven coronary revascularisation.

 

Results:

• Primary outcome occurred in 9.1% of patients in colchicine group, as compared with 9.3% in the placebo group (hazard ratio, 0.99; 95% CI, 0.85 to 1.16; P=0.93).
• There was no difference in death from cardiovascular causes, recurrent MI or stroke (hazard ratio, 0.98; 95% CI, 0.82 to 1.17)
• Death from non-cardiovascular causes occurred in 1.3% of patients in the colchicine group and 1.9% in the placebo group (hazard ratio, 0.68; 95% CI, 0.46 to 0.99)
• Primary outcome was consistent across all pre specified subgroups (age, sex, presence of diabetes, degree of coronary disease, renal function, presentation) aside from dosing. In those patients weighing less than 70kg who received BD dosing had fewer events.
• There was no difference in serious adverse events. More patients reported diarrhoea in the colchicine group (p<0.001). There was no difference in infections between groups.

 

Limitations 

• Women underrepresented.
• High rate of treatment discontinuation (in one quarter of patients in treatment arm)
• Twice daily colchicine was not evaluated.

 

Conclusions

• In patients presenting with STEMI or high risk NSTEMI, treatment with the anti-inflammatory colchicine did not reduce the incidence of death from cardiovascular causes, recurrent myocardial infarction, stroke or unplanned ischaemia-driven coronary revascularisation at a median of 3 years.
• There was no difference in secondary end points
• No difference in serious adverse events, however, increase in reported diarrhoea in colchicine arm
• These results contrast with the previous COLCOT trial, which enrolled 4745 patients within 30 days of AMI and compared colchicine with placebo. This trial demonstrated that colchicine reduced the primary outcome of a composite of death from CV causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularisation. More recent trials evaluating colchicine in patients post stroke have had similar neutral outcomes like this trial. Whilst it is unclear why there is a lack of consistency in results, the most recent trials have also been neutral.
• There is an ongoing need to assess therapeutics that impact different parts of the inflammatory pathways in large clinical trials.

 

Fast-Track Pathway for treatment of Severe Aortic Stenosis

GIRFT has now published a Fast-track Pathway for Aortic Stenosis, in collaboration with BCIS, which should help improve access to aortic stenosis treatment. The document is available on the GIRFT website  or via the link below.

Importantly, the pathway identifies a “fast-track group”. The aim is for these patients to be seen in clinic within two weeks of referral, and treated within 8 weeks. The fast-track group consists of symptomatic patients with:

• Peak flow velocity >5m/s
• Peak flow velocity >4m/s with impaired LV function
• Bioprostheses with peak flow velocity >4m/s or severe AR

And without:
• Severe immobility
• Severe frailty
• Impaired cognition

This grouping is intentionally simplistic and therefore easy to remember and should help ensure that those with the most to gain are prioritised for early treatment. We recommend communicating this pathway to your senior hospital management, as well as to the cardiac network and integrated care board within which you work, seeking their support in its implementation. The precise pathway for delivering referral to treatment will undoubtedly vary in different networks, depending on local structures.

NICOR publishes 2025 National Cardiac Audit Programme (NCAP) Annual Report

We are delighted to share with you the 2025 National Cardiac Audit Programme (NCAP) Annual Report, the annual summary report for patients, carers and the public and the 10 interactive clinical domain summary reports.

Covering the 12 months from 1 April 2023 to 31 March 2024, this year’s report provides evidence that the landscape of cardiovascular disease is evolving. There are clear examples of good practice across the NHS, however challenges and pressures persist – including in cardiovascular services. In some regions, waiting lists for elective cardiovascular treatments are growing longer, urgent admissions face delays, and care inequalities and variances remain a significant concern.

The NCAP analyses combined with inputs from clinical colleagues, patients, and carers, have provide accessible insights into the performance of cardiovascular services, highlighting both successes and areas where improvements can be made.

Thank all our colleagues, community representative group members and stakeholders for their continued support and contribution. Particularly our clinical colleagues, their supporting audit and clerical teams, and their hospital management teams for ensuring that important data are collected and sent to NICOR. We hope our annual reports put these data into context.

The annual report is accompanied by 10 interactive sub-specialty clinical reports that offer detailed, domain-level analyses. These interactive tools enable users to:

• drill down into the performance of different regions and individual hospitals
• focus on specific areas of interest to better understand local trends and outcomes.

These reports can be found on the NICOR website.

Understanding the continued pressures on hospitals and their clinical teams, we are most grateful for your continuing hard work and contributions to the NCAP.

We also invite you to contribute your comments, feedback, queries, or suggestions for future reports. Please NICOR: nicor.auditenquiries@nhs.net.