China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction - CTS-AMI

Oct 31, 2023
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
China National Center for Cardiovascular Diseases
Date Published:
10/24/2023
Date Updated:
10/31/2023
Original Posted Date:
10/31/2023
References

Contribution To Literature:

The CTS-AMI trial showed that Tongxinluo improves cardiovascular outcomes vs. placebo among STEMI patients.

Description:

The goal of the trial was to evaluate Tongxinluo, a Chinese compound of powders/extracts from plants and insects, compared with placebo.

Study Design

  • Randomized
  • Parallel
  • Double-blind
  • Placebo-controlled

Patients with ST-segment elevation myocardial infarction (STEMI) were randomized to Tongxinluo (n = 1,899) vs. placebo (n = 1,898).

  • Total number of enrollees: 3,797
  • Duration of follow-up: 12 months
  • Mean patient age: 61 years
  • Percentage female: 23%
  • Percentage with diabetes: 22%

Inclusion criteria:

  • Patients ≥18 years of age with STEMI

Exclusion criteria:

  • Mechanical complication
  • Acute systolic congestive heart failure or cardiogenic shock
  • Malignant uncontrolled arrhythmia
  • Severe comorbidities
  • Bleeding tendency
  • Limited life expectancy

Other salient features/characteristics:

  • Left ventricular ejection fraction: mean 57%

Principal Findings:

The primary outcome, cardiovascular death, myocardial reinfarction, emergent coronary revascularization, or stroke at 30 days, was: 3.4% in the Tongxinluo group vs. 5.2% in the control group (p = 0.006). Outcomes were the same in all tested subgroups.

Secondary outcomes:

  • Cardiovascular death: 3.0% in the Tongxinluo group vs. 4.2% in the control group (p = 0.04)
  • Myocardial reinfarction: 0% in the Tongxinluo group vs. 0.5% in the control group (p = 0.003)
  • Major bleeding: 0.4% in the Tongxinluo group vs. 0.7% in the control group (p = 0.23)

Interpretation:

Among patients with STEMI, Tongxinluo improves cardiovascular outcomes. Tongxinluo compared with placebo reduces adverse cardiovascular events. Tongxinluo was not associated with an increase in major bleeding. The mechanism of action for the beneficial effect of Tongxinluo is unknown and deserves further study.

References:

Yang Y, Li X, Chen G, et al., on behalf of the CTS-AMI Investigators. Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial. JAMA 2023;330:1534-45.

Editorial: Bach RG. Traditional Chinese Medicine Meets Evidence-Based Medicine in the Acutely Infarcted Heart. JAMA 2023;330:1529-30.

Clinical Topics: Acute Coronary Syndromes

Keywords: Acute Coronary Syndrome, Complementary Therapies


< Back to Listings