Takeaway
- Oral anticoagulation alone was associated with a lower incidence of serious bleeding over 1 month or 1 year vs oral anticoagulation plus clopidogrel in patients with atrial fibrillation (Afib) after transcatheter aortic valve implantation (TAVI).
Why this matters
- The rates of complications for TAVI, particularly those related to bleeding remain high.
- Current guidelines recommended the use of a vitamin K antagonist with or without antiplatelet therapy for 3-6 months after TAVI in patients with a long-term indication for oral anticoagulation based on expert opinion.
Study design
- In this POPular TAVI trial, 313 patients with Afib undergoing TAVI were randomly assigned (1:1) to receive either anticoagulation alone or anticoagulation plus clopidogrel.
- Primary outcome: all bleeding and non-procedure-related bleeding over 12 months.
- Secondary outcomes were divided into the following:
- Composite outcome 1: death from cardiovascular (CV), non-procedure-related bleeding, stroke or myocardial infarction (MI).
- Composite outcome 2: death from CV causes, ischaemic stroke, and MI.
- Funding: The Netherlands Organization for Health Research and Development.
Key results
- Anticoagulation vs anticoagulation plus clopidogrel group had a lower risk of:
- all bleeding (21.7 % vs 34.6%; risk ratio [RR], 0.63; 95% CI, 0.43-0.90; P=.01); and
- non-procedure-related bleeding (21.7% vs 34.0%; RR, 0.64; 95% CI, 0.44-0.92; P=.02).
- Patients who received anticoagulation alone vs anticoagulation plus clopidogrel were at a lower risk of:
- secondary composite 1 (difference, −14.3 [95% CI for non-inferiority, −25.0 to −3.6] percentage points; RR, 0.69; 95% CI for superiority, 0.51-0.92); and
- secondary composite 1 (difference, −3.9 [95% CI for non-inferiority, -11.9 to 4.0] percentage points; RR, 0.77; 95% CI for superiority, 0.46-1.31).
Limitations
- Risk of potential bias.
Nijenhuis VJ, Brouwer J, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Toušek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N. Engl. J. Med.2020 Mar 29 [Epub ahead of print]. doi: 10.1056/NEJMoa1915152. PMID: 32223116. View abstract.
This clinical summary first appeared on Univadis from Medscape.
