Objective:

2

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:

2

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 initia

tion 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:

2

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% lower 30-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% at 6 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:

2

Adjunctive Tongxinluo therapy demonstrated significant improvement in 12-month cardiovascular outcomes with favorable safety profile

suggesting potential benefits of integrating traditional Chinese medicine with evidence-based STEMI management. (Registration No. ChiCTR100054466)