In a groundbreaking study conducted in China, a traditional Chinese medicine compound called Tongxinluo has shown promising results in improving clinical outcomes for patients with ST-segment elevation myocardial infarction (STEMI). Tongxinluo has improved clinical outcomes for both a 1-month and 1-year duration.
The study results were published in the journal JAMA Network.
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Acute ST-segment elevation myocardial infarction (STEMI) is a major life-threatening condition affecting people worldwide. High risks of in-hospital mortality and recurrent cardiovascular events are faced by patients, despite reperfusion therapy and optimal medical management. Tongxinluo is a traditional Chinese medicine compound that is composed of powders and extracts from multiple plant and insect products. Previous in vitro and in vivo studies claimed the efficacy of Tongxinluo in improving myocardial infarction in STEMI patients. Hence, researchers conducted a Randomized, double-blind, placebo-controlled clinical trial to investigate whether Tongxinluo could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).
The study was carried out in 124 hospitals across China. It included patients who had experienced a STEMI within 24 hours of symptom onset and enrolled them between May 2019 and December 2020, with follow-up continuing until December 15, 2021. During the trial, patients were randomly assigned to one of two groups. Half received Tongxinluo, a traditional Chinese medicine compound, while the other half received a placebo. This treatment was administered orally for 12 months, with a loading dose of 2.08 grams immediately after randomization, followed by a maintenance dose of 1.04 grams, taken three times a day. Additionally, both groups received standard guideline-directed treatments for STEMI. The study's primary endpoint was to evaluate 30-day major adverse cardiac and cerebrovascular events (MACCEs). This composite endpoint included cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke.
Key Findings:
The results were significant.
Of the 3,797 patients who participated in the study, 3,777 were included in the primary analysis.
The Tongxinluo group, which comprised 1,889 patients, demonstrated a 30-day MACCE rate of 3.4%, compared to the placebo group's rate of 5.2%. This represents a relative risk reduction of 36% (RR 0.64) and a risk difference of -1.8%.
Further analysis of individual components of MACCEs revealed that the Tongxinluo group experienced significantly fewer cardiac deaths (3.0% vs. 4.2%) within the 30-day period.
These positive outcomes continued beyond the initial 30-day period. At the one-year mark, the Tongxinluo group maintained lower rates of MACCEs (5.3% vs. 8.3%) and cardiac deaths (4.5% vs. 6.1%).
The study also explored several secondary endpoints, such as 30-day stroke, major bleeding at 30 days and one year, one-year all-cause mortality, and in-stent thrombosis at various intervals. Interestingly, no significant differences were found in these secondary measures, suggesting that the benefits of Tongxinluo were primarily seen in reducing cardiac events.
However, it is worth noting that the Tongxinluo group experienced more adverse drug reactions compared to the placebo group, primarily driven by gastrointestinal symptoms.
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In conclusion, this study suggests that Tongxinluo, when used in addition to guideline-directed treatments for STEMI, significantly improves clinical outcomes, reducing the risk of MACCEs and cardiac death, both at 30 days and one year. While these findings are promising, further research is needed to understand the underlying mechanisms of Tongxinluo's effects on STEMI. Regulatory agencies and medical professionals will likely require more robust evidence before considering the integration of traditional Chinese medicine into standard medical practice for STEMI patients. This groundbreaking research offers hope for potential advancements in heart attack treatment, emphasizing the importance of exploring traditional medicine in conjunction with modern medical practices.
Further reading: Yang Y, Li X, Chen G, et al. Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial. JAMA. 2023;330(16):1534–1545. doi:10.1001/jama.2023.19524