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Objective <p>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.</p> Methods <p>This multicenter prospective cohort study enrolled STEMI patients from 122 certified chest pain centers in China. Participants were stratified into exposure (<i>n</i>=1,598) and non-exposure (<i>n</i>=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.</p> Results <p>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%) <i>vs</i>. 64 (4.0%)] and 6 months [MACCEs: 33 (2.1%) <i>vs</i>. 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%) <i>vs</i>. 104 (6.5%)] and 66% at 12 months [43 (2.7%) <i>vs</i>. 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.</p> Conclusions <p>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)</p>

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

  • 期刊论文

  • 发表日期：

    2025年11月10日

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  • Guo-qiang Yuan,
  • Cheng-cheng Chang,
  • Li-min Yang,
  • Li-bo Yang,
  • Mu-tian Xiao,
  • Xiao-xia Wei,
  • Xin-xin Kang,
  • Yong-hui Sun

摘要

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% 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

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)