Highlights from

ACC 2020

Together with World Congress of Cardiology

Virtual 28 - 30 March 2020

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 event including major life-threatening bleeding events, without increasing the rate of thrombotic events.

The POPular TAVI trial is an investigator-initiated, randomised, open-label trial conducted in 17 centres in Europe. Dr Vincent Nijenhuis (St. Antonius Hospital Nieuwegein, the Netherlands) presented the results for one of the two study cohorts [1]. 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).

  1. Nijenhuis V, et al. Antithrombotic Therapy After Transcatheter Aortic Valve Implantation In Patients With A Long-term Indication For Oral Anticoagulation (POPular TAVI Trial - Cohort B). Abstract 405-08. ACC/WCC 28-30 March 2020.

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