Bleeding reduction post-TAVI with OAC alone vs OAC + clopidogrel

In patients with an established indication for oral anticoagulation (OAC) undergoing transcatheter aortic valve implantation (TAVI), OAC alone as compared with OAC + clopidogrel reduced the rate of bleeding events, including major life-threatening bleeding events, without increasing the rate of thrombotic events [1,2].

The POPular TAVI trial is an investigator-initiated, randomised, open-label trial conducted in 17 centres in Europe. The purpose of this trial was to investigate whether extra antithrombotic protection post-TAVI was coupled with extra safety issues. Dr Vincent Nijenhuis (St. Antonius Hospital, the Netherlands) presented the results for 1 of the 2 study cohorts. This cohort consists of patients who were undergoing TAVI and had an established indication for long-term OAC. Patients were randomised to receive clopidogrel on top of their existing oral anticoagulation therapy (n=156) or oral anticoagulation therapy alone (n=157), which was either a direct oral anticoagulant (DOAC) or a vitamin K antagonist. The co-primary endpoints were all bleeding complications (Valve Academic Research Consortium [VARC-2]) and non-procedural bleeding complications (Bleeding Academic Research Consortium type 4 [BARC]) at 1 year after TAVI. Secondary endpoints consisted of cardiovascular (CV) mortality, non-procedural bleeding, all-cause stroke, or myocardial infarction (MI) as well as the efficacy endpoint defined as CV mortality, ischaemic stroke, or MI at 1 year after TAVI. Mean age of the patients was 81 years and 95% had atrial fibrillation. The adherence for 3 months clopidogrel was 95.5%.

At 1 year after TAVI, results showed that OAC alone was superior with regard to the primary endpoint with rates of 21.7% for OAC alone versus 34.6% for OAC + clopidogrel (risk ratio [RR] 0.63; 95% CI 0.43-0.90; P=0.011). Non-procedural bleeding occurred in 21.7% versus 34.0%, respectively (RR 0.64; 95% CI 0.44-0.92; P=0.015). The rates for CV mortality, non-procedural bleeding, stroke, or MI were 31.2% versus 45.5% (RR 0.69; 95% CI 0.51-0.92), and 13.4% versus 17.3% for the efficacy endpoint of CV mortality, ischaemic stroke, or MI (RR 0.77; 95% CI 0.46-1.31). In brief, the trial data argued against adding clopidogrel on top of oral anticoagulation in TAVR patients with a DOAC indication in order to reduce their risk of bleeding. It is important to note that while the authors evaluated antithrombotic therapy in this cohort, the primary endpoint was bleeding, not efficacy. Therefore, the trial was not powered to understand differences in ischaemic outcomes and the upper confidence interval for risk was 1.31. Thus, the conclusions should be limited to safety.

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   1. Nijenhuis VJ, et al. Abstract 405-08. ACC/WCC 28-30 March 2020.
   2. Nijenhuis VJ, et al. N Engl J Med 2020; DOI: 10.1056/NEJMoa1915152.

 



Posted on 7 September 20209 December 2020