Daily Cardiology Research Analysis
Three rigorously conducted clinical studies reshape cardiology practice: a double-blind RCT shows that adding aspirin to oral anticoagulation in chronic coronary syndrome increases ischemic events, death, and major bleeding; an RCT supports P2Y12 inhibitor monotherapy after 1 month in low-risk AMI PCI patients with lower bleeding; and an individual participant data meta-analysis indicates transcatheter aortic valve implantation reduces 1-year death or stroke versus surgery in low–intermediate ri
Summary
Three rigorously conducted clinical studies reshape cardiology practice: a double-blind RCT shows that adding aspirin to oral anticoagulation in chronic coronary syndrome increases ischemic events, death, and major bleeding; an RCT supports P2Y12 inhibitor monotherapy after 1 month in low-risk AMI PCI patients with lower bleeding; and an individual participant data meta-analysis indicates transcatheter aortic valve implantation reduces 1-year death or stroke versus surgery in low–intermediate risk severe aortic stenosis.
Research Themes
- Antithrombotic optimization in coronary disease
- Bleeding risk reduction through de-escalation strategies post-PCI
- Structural heart intervention selection (TAVI vs SAVR) in severe aortic stenosis
Selected Articles
1. Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation.
In a multicenter, double-blind RCT of 872 chronic coronary syndrome patients already on long-term oral anticoagulation, adding daily aspirin increased the composite of cardiovascular events, all-cause mortality, and major bleeding versus placebo, prompting early trial termination. Results argue against routine aspirin on top of oral anticoagulation in this high-risk group.
Impact: This double-blind RCT provides definitive evidence that aspirin on top of oral anticoagulation harms high-risk CCS patients, challenging common additive strategies and informing guideline updates.
Clinical Implications: Avoid routine aspirin addition to oral anticoagulation in chronic coronary syndrome with prior stenting and high atherothrombotic risk; prioritize OAC monotherapy unless a compelling short-term indication exists, and re-evaluate bleeding risk regularly.
Key Findings
- Primary composite endpoint occurred in 16.9% with aspirin vs 12.1% with placebo (adjusted HR 1.53).
- All-cause mortality was higher with aspirin: 13.4% vs 8.4% (adjusted HR 1.72).
- Major bleeding tripled with aspirin: 10.2% vs 3.4% (adjusted HR 3.35); trial stopped early for excess deaths.
Methodological Strengths
- Multicenter, double-blind, randomized, placebo-controlled design
- Hard clinical endpoints with adjudication and prespecified analyses
Limitations
- Early termination may inflate effect estimates and limits long-term assessment
- Conducted in France; generalizability to other health systems requires caution
Future Directions: Define subgroups (e.g., recent stenting, complex PCI) where short-term aspirin may still be warranted; evaluate alternative strategies (e.g., OAC plus P2Y12 inhibitor) and personalized bleeding/ischemia risk tools.
2. Transcatheter or Surgical Treatment of Patients With Aortic Stenosis at Low to Intermediate Risk: An Individual Participant Data Meta-Analysis.
An IPD meta-analysis of 4 investigator-initiated RCTs (n=2873), augmented by aggregate data from industry trials, showed TAVI reduced 1‑year all-cause death or any stroke versus SAVR in low–intermediate risk severe AS (overall HR ~0.76). Results support TAVI as an alternative in this population, while underscoring the need for long-term durability and safety data.
Impact: Pooled patient-level evidence strengthens external validity beyond single trials, informing heart teams when selecting TAVI vs SAVR in low–intermediate risk patients.
Clinical Implications: For suitable low–intermediate risk AS patients, TAVI can be considered to reduce 1-year death/stroke; decisions should integrate anatomy, frailty, coronary/access considerations, and valve durability until longer-term outcomes mature.
Key Findings
- IPD meta-analysis of 4 RCTs (n=2873) showed TAVI reduced 1‑year death or any stroke vs SAVR (1‑stage HR 0.73; 95% CI 0.56–0.95).
- Overall 2-stage meta-analysis across 8 RCTs confirmed benefit (HR 0.76; 95% CI 0.60–0.97).
- Secondary outcomes included signals favoring TAVI (e.g., less new-onset atrial fibrillation), while pacemaker needs remain a consideration.
Methodological Strengths
- Individual participant data pooled from investigator-initiated RCTs with harmonized endpoints
- Complemented by aggregate data to increase power and generalizability
Limitations
- Primary analyses focused on 1-year outcomes; long-term valve durability and complications unresolved
- Heterogeneity in devices, surgical techniques, and periprocedural care across trials
Future Directions: Extended follow-up IPD analyses to evaluate durability, structural valve deterioration, conduction disturbance, and valve-in-valve feasibility; assessment of subgroups (e.g., bicuspid valves, younger patients).
3. Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction.
In low-risk AMI patients with early complete revascularization and 1 month of event-free DAPT, switching to P2Y12 inhibitor monotherapy was noninferior to continuing DAPT for 11 months for the composite of death, MI, stent thrombosis, stroke, or major bleeding, and halved clinically relevant bleeding. Stent thrombosis was rare in both arms.
Impact: Provides high-quality randomized evidence supporting DAPT de-escalation in a clearly defined low-risk AMI PCI population, enabling bleeding reduction without ischemic penalty.
Clinical Implications: For selected low-risk AMI patients with complete revascularization and event-free first month, consider stopping aspirin at 1 month and continuing P2Y12 inhibitor monotherapy to reduce bleeding risk; apply careful patient selection and contrast with data from earlier aspirin withdrawal trials.
Key Findings
- Primary composite event: 2.1% with P2Y12 monotherapy vs 2.2% with continued DAPT (noninferior; difference -0.09 percentage points; P=0.02).
- Clinically relevant bleeding (BARC 2/3/5) reduced: 2.6% vs 5.6% (HR 0.46; 95% CI 0.29–0.75).
- Stent thrombosis infrequent and similar between groups; serious adverse events comparable.
Methodological Strengths
- Multicenter randomized design with prespecified noninferiority margin and clinically relevant composite endpoint
- Contemporary practice: complete revascularization, modern DES, and standardized follow-up
Limitations
- Open-label design may introduce performance bias (though hard endpoints mitigate this)
- Generalizability limited to low-risk AMI with complete revascularization and event-free first month
Future Directions: Evaluate de-escalation in broader or higher-risk AMI populations, optimal P2Y12 agent choice, and integration with anticoagulation in atrial fibrillation after PCI.