Tongxinluo Adjunctive Therapy and 12-Month Cardiovascular Outcomes after ST-Segment Elevation Myocardial Infarction:A Real-World Multicenter Prospective Cohort StudyOA

Objective:To evaluate the efficacy and safety of Tongxinluo in improving medium-and long-term prognosis of patients with ST-segment elevation myocardial infarction(STEMI)in a real-world setting.Methods:This multicenter prospective cohort study enrolled STEMI patients from 122 certified chest pain centers in China.Participants were stratified into exposure(n=1,598)and non-exposure(n=1,600)groups based on Tongxinluo administration initiation before or within 24 h post-reperfusion.Both groups received percutaneous coronary intervention(PCI)or thrombolysis with guideline-based therapy.The primary endpoint was incidence of major adverse cardiovascular and cerebrovascular events(MACCEs)at 12 months.Secondary endpoints included the incidence of severe STEMI complications at 30 days;MACCEs at 30 days and 6 months;composite endpoint events at 6 and 12 months;and all-cause mortality at 30 days,6 months,and 12 months.Results:A total of 3,198 patients were included in the primary analysis.The primary endpoint,MACCEs incidence at 12 months,was significantly lower in the exposure group[40(2.5%)vs.106(6.6%)],driven by reductions in cardiac death and stroke.In the secondary endpoint analysis,early risk reduction was pronounced at 30 days[MACCEs:19(1.2%)vs.64(4.0%)]and 6 months[MACCEs:33(2.1%)vs.90(5.6%)].The exposure group exhibited 92%lower30-day STEMI complications[16(1.0%)vs.210(13.1%)],including reductions in cardiogenic shock,acute heart failure,mechanical complications,and malignant arrhythmias.Composite endpoint risks decreased by 65%at6 months[36(2.3%)vs.104(6.5%)]and 66%at 12 months[43(2.7%)vs.127(7.9%)],with significant heart failure readmission reductions and 89%lower severe bleeding risk.More surprisingly,the risk of all-cause death at 30 days,6 months,and 1 year was reduced by 71%,61%and 59%in the exposure group.Conclusions:Adjunctive Tongxinluo therapy demonstrated significant improvement in 12-month cardiovascular outcomes with favorable safety profile,suggesting potential benefits of integrating traditional Chinese medicine with evidencebased STEMI management.(Registration No.ChiCTR100054466).