POPular TAVI: Aspirin-only antiplatelet strategy?

The POPular TAVI trial continues to fuel debate and challenge current concepts of antiplatelet treatment after transcatheter aortic valve implantation (TAVI). Reported by Dr Jorn Brouwer (St Antonius Hospital, the Netherlands), the trial concluded that aspirin alone after TAVI reduces bleeding events significantly and does not increase the rate of thromboembolic events [1,2].

The ESC Guidelines recommend adding clopidogrel to aspirin therapy for 3-6 months after TAVI to mitigate thromboembolic risk. However, the POPular TAVI trial questioned the benefit of antiplatelet therapy with clopidogrel and hypothesised that patients taking aspirin alone compared with patients taking aspirin plus clopidogrel for 3 months would have a reduced bleeding rate at 1-year post-TAVI. To this end, 2 cohorts were investigated: patients not on oral anticoagulants (cohort A) and patients on chronic oral anticoagulation (cohort B). Dr Brouwer presented the results of cohort A.

A total of 665 patients without an indication for oral anticoagulation were randomised to aspirin alone (n=331) or aspirin plus 3 months of clopidogrel (n=334). The co-primary outcomes were all bleeding (i.e. procedural and non-procedural) together with non-procedural bleeding. In addition, POPular TAVI was designed to determine whether aspirin alone is non-inferior to aspirin plus clopidogrel with respect to 2 secondary outcomes at 1 year.

The co-primary outcomes were met; aspirin alone resulted in a significantly lower incidence of bleeding compared with aspirin plus clopidogrel at 1 year (15.1% vs 26.6%, respectively; RR 0.57; 95% CI 0.42-0.77; P=0.001) [1]. Non-procedural bleeding also favoured the aspirin only arm (15.1% vs 24.9%; RR 0.61; 95% CI 0.44-0.83; P=0.005). Likewise, the secondary outcome on bleeding and thromboembolic events indicated that aspirin alone was superior in this study (23.0% vs 31.1%; RR 0.74; 95% CI for non-inferiority 0.57- 0.95 P<0.001; 95% CI for superiority 0.57-0.95; P=0.04). The thromboembolic events secondary outcome was also significant for aspirin (9.7% vs9.9%; RR 0.98; 95% CI for non-inferiority 0.62-1.55; P=0.004).

Dr Brouwer concluded: “The trial showed that aspirin alone should be used in patients undergoing TAVI who are not on oral anticoagulation and have not recently undergone coronary stenting.”

 

1. 
   
   1. Brouwer J, et al. POPULAR TAVI- Aspirin with or without clopidogrel after transcatheter aortic valve implantation. Hot Line 2 session, ESC Congress 2020, 30 Aug.
   2. Brouwer J, et al. N Engl J Med. 2020; Aug 30.DOI:10.1056/NEJMoa2017815.

 



Posted on 5 November 20208 February 2024