Among high-risk patients who underwent percutaneous coronary intervention (PCI), stopping aspirin after three months of dual antiplatelet therapy led to less bleeding than continuing ticagrelor plus aspirin, an industry-funded study found.
After three months of treatment with ticagrelor plus aspirin, 7,119 patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for one year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). Researchers also evaluated a composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. Results of the study, which was funded by AstraZeneca, were published by the New England Journal of Medicine on Sept. 26.
Between randomization and one year, the primary end point occurred among 4.0% of patients randomized to ticagrelor plus placebo and 7.1% of patients assigned to ticagrelor plus aspirin (hazard ratio [HR], 0.56; 95% CI, 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for the outcome of BARC type 3 or 5 bleeding (incidence, 1.0% with ticagrelor plus placebo and 2.0% with ticagrelor plus aspirin; HR, 0.49 [95% CI, 0.33 to 0.74]).
The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, −0.06 percentage point; 95% CI, −0.97 to 0.84 percentage point). The HR for this composite end point was 0.99 (95% CI, 0.78 to 1.25; P<0.001 for noninferiority).
The authors wrote, “From a clinical standpoint, our results suggest that ticagrelor monotherapy may be a suitable antiplatelet strategy to lower the risk of bleeding while simultaneously preserving ischemic benefit in patients who have undergone PCI and are characterized by a minimum threshold of risk. These effects appear consistent in patients whose condition is either stable or acute.”