Guanxinning tablets plus aspirin versus aspirin monotherapy to reduce cardiovascular events after percutaneous coronary intervention: A cluster-randomized controlled trial (GAP trial)

BACKGROUND: Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) lowers thrombotic risk but increases bleeding, creating a therapeutic dilemma. Guanxinning tablets (GXNT), a traditional Chinese medicine with antithrombotic and cardioprotective effects, may offer an alternative strategy. PURPOSE: To evaluate whether GXNT combined with aspirin reduces cardiovascular events without increasing bleeding in patients transitioning from DAPT to aspirin monotherapy after PCI. STUDY DESIGN: An open-label, cluster-randomized controlled trial conducted in 63 tertiary hospitals in China between March 2017 and December 2018. METHODS: A total of 3586 patients with coronary heart disease (CHD) who had completed at least 12 months of DAPT following PCI were enrolled. Hospitals and participants were randomized in a 2:1 ratio to receive GXNT plus aspirin or aspirin alone for 12 months, followed by 12 months of additional follow-up. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, revascularization, ischemic stroke, and rehospitalization for unstable angina. Outcome assessors and data analysts were blinded to treatment allocation. The intention-to-treat analysis principle was adopted, and ICC were accounted for in the statistical analysis. RESULTS: Of the participants, 2389 received GXNT plus aspirin and 1197 received aspirin alone. After a median follow-up of 23 months, GXNT significantly reduced the primary outcome (11.0 % vs. 13.2 %; adjusted hazard ratio [HR] 0.79, 95 % confidence interval [CI] 0.63-0.98). Rates of revascularization (3.8 % vs 4.7 %) and rehospitalization for unstable angina (7.0 % vs 9.7 %) were also lower in the GXNT group. Major bleeding events were rare and similar across groups. CONCLUSION: GXNT combined with aspirin reduced adverse cardiovascular events after PCI without increasing bleeding, supporting its potential as an alternative to prolonged DAPT.