Guanxinning tablets plus aspirin versus aspirin monotherapy to reduce cardiovascular events after percutaneous...

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.

To evaluate whether GXNT combined with aspirin reduces cardiovascular events without increasing bleeding in patients transitioning from DAPT to aspirin monotherapy after PCI.

An open-label, cluster-randomized controlled trial conducted in 63 tertiary hospitals in China between March 2017 and December 2018.

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.

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.

GXNT combined with aspirin reduced adverse cardiovascular events after PCI without increasing bleeding, supporting its potential as an alternative to prolonged DAPT.