Non-inferiority of 1 month versus longer dual antiplatelet therapy in patients undergoing PCI with drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials

Abstract

Aim: The aim of this meta-analysis was to evaluate the safety of 1-month dual antiplatelet therapy (DAPT) followed by aspirin or a P2Y12 receptor inhibitor, after percutaneous coronary intervention (PCI) with drug-eluting stents (DES), based on the available evidence. Methods: PubMed, MEDLINE, Embase, Scopus, Google Scholar, CENTRAL, and ClinicalTrials.gov database search identified four RCTs of 26,431 patients who underwent PCI with DES and compared 1-month versus >1-month DAPT. The primary endpoint was major bleeding and co-primary endpoint stent thrombosis, and secondary endpoints included all-cause mortality, cardiovascular death, myocardial infarction (MI), stroke, and major adverse clinical events (MACE). Results: Compared with >1-month DAPT, the 1-month DAPT was associated with a similar rate of major bleeding (OR = 0.74, 95%CI: 0.51–1.07, p = 0.11, I2 = 67%), stent thrombosis (OR = 1.10, 95%CI: 0.82–1.47, p = 0.53, I2 = 0.0%), similar risk for all-cause mortality (OR = 0.89, 95%CI: 0.77–1.04, p = 0.14, I2 = 0%), CV death (OR = 0.80, 95% CI: 0.55–1.60, p = 0.24, I2 = 0.0%), MI (OR = 1.02, 95% CI: 0.88–1.19, p = 0.78, I2 = 0.0%), and stroke (OR = 0.76, 95% CI: 0.54–1.08, p = 0.13, I2 = 29%). The risk of MACE was lower (OR = 0.84, 95% CI: 0.73–0.98, p = 0.02, I2 = 39%) in the 1-month DAPT compared with the >1-month DAPT. Only patients with stable CAD had lower risk of MACE with 1-month DAPT (OR = 0.81, 95% CI: 0.67–0.98, p = 0.03, I2 = 21%) compared with >1-month DAPT. Conclusion: This meta-analysis proved the non-inferiority of 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor compared with long-term DAPT in patients undergoing PCI with DES.