A patient level meta-analysis found that P2Y12 inhibitor monotherapy and dual antiplatelet therapy (DAPT) had similar risks for death, myocardial infarction, or stroke. These findings were published in The BMJ.
Publication databases were searched for trials of patients undergoing percutaneous or surgical revascularization for coronary artery disease who were treated with P2Y12 inhibitor or DAPT. Patients’ clinical outcomes were assessed.
This study included 6 studies comprising 24,096 participants, 12,037 of whom were randomly assigned to receive P2Y12 inhibitor monotherapy and 12,059 to receive DAPT. The intention-to-treat analysis excluded 8.2% of patients due to lack of data sharing approval.
The P2Y12 inhibitors included ticagrelor (77.0%), clopidogrel (22.2%), or prasugrel (0.8%) and DAPT included aspirin with ticagrelor (62.0%), clopidogrel (36.8%), or prasugrel (1.2%).
Patients had a mean age of 65 years and 23.3% were women. Of all the patients, 30.3% had a previous percutaneous coronary intervention, 31.8% had diabetes, and 16.6% had chronic kidney disease.
The composite endpoint of death, myocardial infarction, or stroke occurred among 2.95% of the monotherapy and 3.27% of the DAPT cohorts (hazard ratio [HR], 0.93; 95% CI, 0.79-1.09; P =.38). No evidence of heterogeneity was observed (t2, 0.00). A similar trend was reported for the intention-to-treat population (HR, 0.90; 95% CI, 0.77-1.05; P =.18; t2, 0.00).
Compared with DAPT, the P2Y12 inhibitor monotherapy was not associated with decreased risk for all-cause mortality (HR, 0.80; 95% CI, 0.62-1.03), myocardial infarction (HR, 0.93; 95% CI, 0.75-1.14), definite stent thrombosis (HR, 0.85; 95% CI, 0.48-1.50), or all stent thrombosis (HR, 0.81; 95% CI, 0.49-1.37).
The monotherapy was associated with a decreased risk for cardiovascular death (0.57% vs 0.90%; HR, 0.69; 95% CI, 0.50-0.95; t2, 0.00) and Bleeding Academic Research Consortium events type 3 or 5 (HR, 0.89% vs 1.83%; HR, 0.49; 95% CI, 0.39-0.63; t2, 0.03).
The investigators observed a treatment-by-sex interaction for all-cause mortality (P =.02), in which women who received the monotherapy were at decreased risk for cardiovascular death (HR, 0.31; 95% CI, 0.15-0.65).
This analysis may have been limited by the underlying trial designs, in which 5 of the 6 were open-label trials and the investigators did not correct for multiple testing.
These data indicated after percutaneous or surgical revascularization for coronary artery disease, patients receiving P2Y12 inhibitor monotherapy or DAPT had similar composite outcomes, but P2Y12 inhibitors were associated with a decreased risk for major bleeding events and cardiovascular death among women.
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Valgimigli M, Gragnano F, Branca M, et al. P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials. BMJ. 2021;373:n1332. doi:10.1136/bmj.n1332