The POPular TAVI trial findings have established that omitting clopidogrel following transcatheter aortic valve replacement (TAVR) may reduce bleeding. In such case, the exclusive use of aspirin is adequate to prevent thromboembolic events.

The results of trial presented at the virtual European Society of Cardiology (ESC) Congress, was conducted on patients who underwent TAVR, but were not prescribed anticoagulants and also did not undergo stenting recently. The researchers suggested that, “despite the fact that TAVI procedures are more successful nowadays, the incidence of bleeding and thromboembolic events remain high.”

According to the ESC guidelines, it is recommended that dual antiplatelet therapy should be given early after TAVI followed by aspirin or clopidogrel alone in patients not on oral anticoagulants. However, there have been certain clinical studies which have shown that an aspirin-alone treatment approach is successful in reducing the rate of bleeding events but not increasing the frequency of thromboembolic events.

In this study, the main findings showed that the primary co-outcome, all bleeding (minor, major and life-threatening or disabling bleeding) at 12 months, occurred in 15.1% of the aspirin alone group compared with 26.6% of the aspirin plus clopidogrel group (p=0.001). The primary co-outcome, nonprocedure-related bleeding at 12 months, occurred in 15.1% of the aspirin alone group compared with 24.9% of the aspirin plus clopidogrel group (p=0.005).

The study findings indicated that among patients who underwent TAVR and did not have an indication for anticoagulation, exclusive use of aspirin was linked with a reduction in all bleeding and nonprocedure-related bleeding compared with aspirin plus clopidogrel.

These results are suggestive of the fact that aspirin alone compared with aspirin plus clopidogrel was also associated with noninferiority regarding adverse ischemic events (cardiovascular death, stroke or myocardial infarction).

Resource:

Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med. 2020 Aug 30. [Epub ahead of print]