Posted by Carla Rothaus
How did aspirin alone compare with aspirin plus clopidogrel regarding bleeding in cohort A of the POPular TAVI trial?
Brouwer et al. recently reported findings in cohort A of the POPular TAVI trial, which compared bleeding and thromboembolic events with aspirin alone versus aspirin plus clopidogrel in patients undergoing transcatheter aortic-valve implantation (TAVI) who did not have an established indication for long-term oral anticoagulation. Trial findings in cohort B, which included patients undergoing TAVI who had an indication for long-term anticoagulation, were published previously. Read the NEJM Original Article here.
Q: What are current practice guidelines regarding antiplatelet therapy after TAVI for patients without an indication for oral anticoagulation?
A: Practice guidelines recommend clopidogrel in addition to aspirin for the first 3 to 6 months after TAVI in patients who do not have an indication for oral anticoagulation.
Q: Summarize the main findings for cohort B of the POPular TAVI trial.
A: In cohort B of the POPular TAVI trial, clopidogrel in addition to oral anticoagulants was associated with a higher incidence of bleeding and no decrease in the incidence of ischemic events than anticoagulation alone among patients who were receiving indicated long-term oral anticoagulation.
Morning Report Questions
Q: How did aspirin alone compare with aspirin plus clopidogrel regarding bleeding in cohort A of the POPular TAVI trial?
A: In cohort A, Brouwer et al. investigated antiplatelet therapy with aspirin alone as compared with aspirin plus clopidogrel for 3 months after TAVI in patients who did not have an indication for long-term oral anticoagulation. The incidences of the two primary outcome events of all bleeding and non–procedure-related bleeding at 1 year were lower among patients who received aspirin alone than among those who received aspirin plus clopidogrel for 3 months. This result was mainly driven by differences in the incidences of major bleeding. The incidence of severe procedure-related bleeding, defined as Bleeding Academic Research Consortium type 4, was low (1.8%), but it was observed only in patients receiving aspirin plus clopidogrel.
Q: What were the secondary outcome results in the trial by Brouwer et al.?
A: A secondary composite 1 event (bleeding, death from cardiovascular causes, non–procedure-related bleeding, stroke from any cause, or myocardial infarction) occurred in 76 patients (23.0%) receiving aspirin alone and in 104 patients (31.1%) receiving aspirin plus clopidogrel (difference, –8.2 percentage points; 95% CI for noninferiority, –14.9 to –1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P=0.04). A secondary composite 2 event (thromboembolic events, including death from cardiovascular causes, ischemic stroke, or myocardial infarction) occurred in 32 patients (9.7%) receiving aspirin alone and 33 patients (9.9%) receiving aspirin plus clopidogrel (difference, –0.2 percentage points; 95% CI for noninferiority, –4.7 to 4.3; P=0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P=0.93).
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