Daily Cardiology Research Analysis
Three impactful cardiology studies stand out today: an individual patient data meta-analysis shows blood pressure–lowering benefits extend to isolated diastolic hypertension; a prespecified RCT analysis finds early aspirin withdrawal after PCI increases ischemic risk in STEMI but not NSTE-ACS; and a multicenter RCT reports comparable 1-year outcomes for a novel balloon-expandable TAVR valve versus contemporary devices.
Summary
Three impactful cardiology studies stand out today: an individual patient data meta-analysis shows blood pressure–lowering benefits extend to isolated diastolic hypertension; a prespecified RCT analysis finds early aspirin withdrawal after PCI increases ischemic risk in STEMI but not NSTE-ACS; and a multicenter RCT reports comparable 1-year outcomes for a novel balloon-expandable TAVR valve versus contemporary devices.
Research Themes
- Treating isolated diastolic hypertension with antihypertensive therapy
- Aspirin withdrawal timing after ACS and PCI
- Comparative performance of transcatheter aortic valves at 1 year
Selected Articles
1. Blood pressure lowering in isolated diastolic hypertension and cardiovascular risk: an individual patient data meta-analysis.
Pooling 51 RCTs (n=358,325), this IPD meta-analysis shows that a 5 mmHg reduction in systolic BP reduces major cardiovascular events similarly in isolated diastolic hypertension and non-IDH, with no heterogeneity across diastolic BP levels or key subgroups. Findings support treating IDH with standard BP-lowering strategies.
Impact: Resolves a long-standing uncertainty around treating isolated diastolic hypertension by leveraging large-scale individual patient data from 51 RCTs.
Clinical Implications: Clinicians can justify pharmacologic BP lowering in IDH similarly to non-IDH, focusing on overall BP reduction rather than diastolic thresholds, and need not fear harm at lower baseline diastolic pressures.
Key Findings
- Across 358,325 participants (51 RCTs), 5 mmHg systolic BP reduction lowered major cardiovascular events similarly in IDH (HR 0.91; 95% CI 0.82-1.01) and non-IDH (HR 0.90; 95% CI 0.89-0.92).
- No heterogeneity in treatment effect by baseline diastolic BP (P for interaction = 0.26) among those with systolic BP <130 mmHg.
- Relative treatment effects did not differ by prior CVD, age, prior medication use, or BP measurement methods.
Methodological Strengths
- Individual participant data meta-analysis across 51 randomized controlled trials
- Predefined subgroup analyses with robust stratified Cox models
Limitations
- IDH subgroup represented 4.4% of the pooled population, limiting precision for some estimates
- Trial-level differences and fixed-effect one-stage model assumptions may affect generalizability
Future Directions: Evaluate absolute risk reductions and optimal treatment thresholds in contemporary cohorts; assess patient-centered outcomes and potential J-curve effects in specific populations.
BACKGROUND AND AIMS: Blood pressure (BP) lowering reduces cardiovascular disease (CVD) risk; however, the benefits of treating patients with normal systolic BP but elevated diastolic BP remain uncertain. METHODS: Data from 51 randomized controlled trials were pooled to compare BP-lowering effects in participants with and without isolated diastolic hypertension (IDH), defined as systolic BP < 130 mmHg and diastolic BP ≥ 80 mmHg. Treatment effects were stratified across baseline diastolic BP categories (range < 60 to ≥90 mmHg) among individuals with baseline systolic BP < 130 mmHg. Fixed-effect one-stage individual participant data meta-analyses were used, and Cox proportional hazard models, stratified by trial, were applied to analyse the data. RESULTS: Among 358 325 participants, 15 845 (4.4%) had IDH. At a median follow-up of 4.2 years, a 5 mmHg reduction in systolic BP reduced the risk of major cardiovascular events similarly in individuals with IDH [hazard ratio 0.91; 95% confidence interval (CI) 0.82-1.01] and those without IDH (hazard ratio 0.90; 95% CI 0.89-0.92; P for interaction = 1.00). Analyses by baseline diastolic BP showed no evidence of heterogeneity in treatment effects among individuals with baseline systolic BP < 130 mmHg (P for interaction = .26). Relative treatment effects were not statistically different by CVD history, age, prior medication use, and BP measurement methods. CONCLUSIONS: The study found no evidence to suggest that pharmacological BP-lowering therapy in individuals with IDH is less or more effective than in those without IDH. Relative risk reductions also did not diminish in those with lower diastolic BP, down to <60 mmHg at baseline. No meaningful differences across various clinical phenotypes were detected.
2. Potent P2Y12 inhibitor monotherapy with very early aspirin withdrawal after PCI in ACS: differential effects in STEMI vs NSTE-ACS (NEO-MINDSET prespecified analysis).
In this prespecified analysis of 3,410 ACS patients, withdrawing aspirin very early and continuing potent P2Y12 monotherapy increased 1-year ischemic events in STEMI (HR 1.60) but not in NSTE-ACS (HR 0.84), while significantly reducing bleeding in both groups. Early aspirin withdrawal appears harmful in STEMI but may be reasonable in NSTE-ACS.
Impact: Directly informs antiplatelet strategy after PCI by ACS subtype, challenging one-size-fits-all approaches to early aspirin withdrawal.
Clinical Implications: Maintain DAPT early after PCI in STEMI to avoid excess ischemic events; consider early aspirin withdrawal with potent P2Y12 monotherapy in NSTE-ACS to reduce bleeding when ischemic risk is controlled.
Key Findings
- STEMI: Early aspirin-free potent P2Y12 monotherapy increased 1-year ischemic composite vs DAPT (8.2% vs 5.2%; HR 1.60; 95% CI 1.14-2.24).
- NSTE-ACS: Ischemic events were similar between monotherapy and DAPT (5.1% vs 6.0%; HR 0.84; 95% CI 0.53-1.35; interaction P=0.030).
- Bleeding was reduced with monotherapy in both STEMI (HR 0.37) and NSTE-ACS (HR 0.45) with no interaction.
Methodological Strengths
- Prespecified subgroup analysis within a randomized controlled trial
- Large sample with stratification by ACS subtype and standardized 1-year outcomes
Limitations
- Abstract truncation limits detail on trial procedures and timing of aspirin withdrawal
- As a subgroup analysis, residual confounding and multiplicity cannot be fully excluded
Future Directions: Define optimal aspirin discontinuation timing by ACS subtype and lesion characteristics; evaluate platelet function–guided strategies and high-bleeding-risk subgroups.
BACKGROUND: The effects of very early aspirin withdrawal with potent P2Y OBJECTIVES: This prespecified analysis from the NEO-MINDSET trial evaluated whether treatment effects of early aspirin discontinuation differ between ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation ACS (NSTE-ACS; defined as unstable angina or non-ST-segment elevation myocardial infarction). METHODS: NEO-MINDSET randomized ACS patients to potent P2Y RESULTS: Of the 3,410 participants included, 2,119 (62.1%) presented with STEMI and 1,291 (37.9%) with NSTE-ACS. Among STEMI patients, an early aspirin-free strategy was associated with a higher rate of the co-primary ischemic composite outcome compared with DAPT at 1 year (8.2% vs 5.2%, respectively; HR: 1.60; 95% CI: 1.14-2.24), whereas among those with NSTE-ACS, ischemic event rates were similar between monotherapy and DAPT (5.1% vs 6.0%, respectively; HR: 0.84; 95% CI: 0.53-1.35; P for interaction = 0.030). The co-primary bleeding outcome was lower with monotherapy than with DAPT in both STEMI (HR: 0.37; 95% CI: 0.22-0.61) and NSTE-ACS (HR: 0.45; 95% CI: 0.23-0.86) populations (P for interaction = 0.650). CONCLUSIONS: In patients with STEMI treated with percutaneous coronary intervention, early aspirin withdrawal may be harmful, because it increases the risk of ischemic events. Conversely, in NSTE-ACS, potent P2Y
3. 1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial.
In 768 randomized patients with severe aortic stenosis, the novel Myval balloon-expandable THV achieved 1-year outcomes comparable to contemporary SAPIEN/Evolut devices for the composite of death, stroke, or valve-related hospitalization, with similar hemodynamics and quality-of-life measures.
Impact: Provides head-to-head randomized evidence that a new balloon-expandable THV performs comparably at 1 year, informing device selection and market competition.
Clinical Implications: Myval can be considered alongside contemporary THVs for symptomatic severe AS, with device choice tailored to anatomy, access, and operator experience rather than expected differences in 1-year major clinical outcomes.
Key Findings
- Randomized, open-label noninferiority trial (n=768) across 31 centers comparing Myval vs SAPIEN/Evolut THVs.
- 1-year freedom from composite endpoint was similar (Myval 87.0% vs contemporary 86.9%).
- Hemodynamic performance and quality-of-life changes were comparable between devices.
Methodological Strengths
- Multicenter randomized design with intention-to-treat analysis
- Standardized VARC-3 endpoints and inclusion of quality-of-life assessment
Limitations
- Open-label design may introduce performance bias
- A posteriori exploratory noninferiority margin at 1 year; not the original primary endpoint
Future Directions: Assess durability, subclinical leaflet thrombosis, and conduction disturbances over longer follow-up; evaluate anatomical subgroups and valve sizing strategies.
BACKGROUND: In the LANDMARK trial, the Myval balloon-expandable transcatheter heart valve (THV) series was noninferior to the most commonly used contemporary SAPIEN and Evolut Series THVs for the 30-day early safety endpoint in participants with symptomatic severe native aortic stenosis. OBJECTIVES: The current report from the LANDMARK trial describes clinical outcomes, hemodynamic performances, and quality of life at 1 year. METHODS: This open-label, noninferiority trial enrolled 768 participants across 31 hospitals in Europe, New Zealand, and Brazil. Participants were randomly assigned (1:1) to receive either a Myval THV series or a contemporary THV (SAPIEN or Evolut series). The composite endpoint at 1 year included all-cause mortality, all strokes, and procedure- or valve-related hospitalizations. Clinical efficacy was defined as freedom from the composite endpoint. As recommended in Valve Academic Research Consortium-3, the previous composite endpoint combined with the assessment of quality of life at baseline and 1 year with the 12-Item Short Form Health Survey was reported as an extended composite endpoint. The noninferiority hypothesis was prespecified for the assessment of the primary endpoint at 30 days. Considering the specific 1-year composite endpoints of Valve Academic Research Consortium-3 and the event rate of 27.23% derived from recent studies, an a posteriori descriptive and exploratory noninferiority hypothesis was introduced with a noninferiority margin of 10.89%. The analysis was performed in the intention-to-treat population. RESULTS: The mean age was 80 years, 48% were women, and the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 2.6%. There was no significant difference in the Kaplan-Meier estimates of freedom from the composite endpoint at 365 days (Myval THV 87.0% vs contemporary THVs 86.9%). The Myval THV series was noninferior to the contemporary THVs for the composite endpoint (difference: -0.1%; 1-sided 95% CI: 3.9%; P CONCLUSIONS: In the treatment of symptomatic severe native aortic stenosis, the clinical and hemodynamic outcomes of the Myval THV series were comparable to those of contemporary THVs for the 1-year composite of all-cause mortality, all strokes, or procedure- or valve-related hospitalizations. (LANDMARK Trial: a Randomised Controlled Trial of Myval THV [LANDMARK]; NCT04275726).