Treatment with aspirin alone vs in combination with clopidogrel was found to be associated with fewer bleeding events, 1 year after transcatheter aortic-valve implantation (TAVI), according to a study published in the New England Journal of Medicine.
In this randomized controlled trial (ClinicalTrials.gov Identifier: NCT02247128), 665 patients (mean age, 80.0±6.3 years; 48.7% women) with no indication for anticoagulant treatment and scheduled to undergo TAVI were enrolled. Participants were randomly assigned to receive aspirin alone (n=331) and or in combination with clopidogrel (n=334). The study’s primary outcomes were all bleeding and nonprocedure-related bleeding for a period of 12 months after intervention. Secondary outcomes were a composite of death from cardiovascular causes, nonprocedure-related bleeding, stroke, or myocardial infarction (secondary composite 1), and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year.
At 12 months after TAVI, bleeding of any type occurred in 50 patients (15.1%) who received aspirin alone and in 89 participants (26.6%) who received aspirin plus clopidogrel (risk ratio, 0.57; 95% CI, 0.42-0.77; P =.001). Nonprocedure-related bleeding occurred in 50 patients receiving aspirin alone (15.1%) and in 83 patients receiving aspirin plus clopidogrel (24.9%; risk ratio, 0.61; 95% CI, 0.44-0.83; P =.005).
The secondary composite 1 outcome occurred in 76 patients (23.0%) who received aspirin alone and in 104 participants (31.1%) who received aspirin plus clopidogrel (difference, −8.2 percentage points; 95% CI for noninferiority, −14.9 to −1.5; P < .001; risk ratio, 0.74; 95% CI for superiority, 0.57-0.95; P =.04). The secondary composite 2 outcome occurred in 32 patients receiving aspirin alone (9.7%) and in 33 patients (9.9%) receiving aspirin plus clopidogrel (difference, −0.2 percentage points; 95% CI for noninferiority, −4.7 to 4.3; P =.004; risk ratio, 0.98; 95% CI for superiority, 0.62-1.55; P =.93).
Study limitations include its open-label design and the fact that the trial was powered for the composite of bleeding or thromboembolic events rather than thromboembolic events alone.
“Aspirin alone was superior to aspirin plus clopidogrel with respect to the composite of bleeding or thromboembolic events (including death from cardiovascular causes, stroke, myocardial infarction, or nonprocedure-related bleeding),” noted the study authors. “Aspirin alone was noninferior, but not superior, to aspirin plus clopidogrel with respect to the composite of thromboembolic events including death from cardiovascular causes, ischemic stroke, or myocardial infarction.”
Disclosures: Some of the authors declared affiliations with the pharmaceutical industry. Please see the original reference for a complete list of disclosures.
Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin with or without clopidogrel after transcatheter aortic-valve implantation [published online August 30, 2020]. N Engl J Med. doi:10.1056/NEJMoa2017815