Oral anticoagulation alone vs dual therapy reduces bleeding after TAVI

  • Nijenhuis VJ & al.
  • N Engl J Med
  • 29 Mar 2020

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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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.