- Question
- In patients undergoing transcatheter aortic-valve implantation (TAVI) without an indication for long-term oral anticoagulation, is aspirin alone better than aspirin plus clopidogrel with respect to bleeding and thromboembolic events?
- Design
- Randomized, controlled, open-label (unmasked) trial with 1:1 allocation, in a subgroup of patients undergoing TAVI without an indication for long-term oral anticoagulation. A total of 331 patients were assigned to aspirin alone and 334 to aspirin plus clopidogrel, with 12 months of follow-up.
- Population
- Patients undergoing TAVI who had no indication for long-term oral anticoagulation.
- Intervention
- Aspirin alone (low dose, up to 100 mg daily per the registry), with a loading dose before TAVI if the patient was not already taking it.
- Control
- Aspirin plus clopidogrel for 3 months (clopidogrel 75 mg daily per the registry).
- Primary outcome
- Two primary outcomes over 12 months: all bleeding (minor, major, and life-threatening or disabling) and non-procedure-related bleeding.
- Results
- A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio 0.57; 95% CI 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 (15.1%) and 83 (24.9%), respectively (risk ratio 0.61; 95% CI 0.44 to 0.83; P = 0.005). The secondary composite of cardiovascular death, non-procedure-related bleeding, stroke, or myocardial infarction was lower with aspirin alone (23.0% vs 31.1%; risk ratio 0.74; 95% CI 0.57 to 0.95; P = 0.04).
- Safety
- Bleeding was the main safety finding and was more frequent with dual antiplatelet therapy. Oral anticoagulation was received during the trial by 44 patients (13.3%) and 32 (9.6%), respectively.
- Conclusion
- Among patients undergoing TAVI without an indication for oral anticoagulation, aspirin alone led to less bleeding and fewer composite bleeding or thromboembolic events at 1 year than aspirin plus clopidogrel for 3 months.
- Why it matters
- It supported simplifying antithrombotic therapy after TAVI in patients without an anticoagulation indication, favoring single antiplatelet therapy to reduce bleeding without losing protection against ischemic events.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026