Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial.
In: JAMA: Journal of the American Medical Association, Jg. 330 (2023-10-24), Heft 16, S. 1534-1545
academicJournal
Zugriff:
Key Points: Question: Among patients with acute ST-segment elevation myocardial infarction (STEMI), does the addition of a traditional Chinese medicine compound (Tongxinluo) as an adjunctive treatment to guideline-directed therapies improve clinical outcomes? Findings: In this randomized, double-blind, placebo-controlled clinical trial of 3777 patients with STEMI, oral administration of Tongxinluo for 12 months, compared with placebo, significantly reduced the primary end point of 30-day major adverse cardiac and cerebrovascular events (rate of MACCEs, 3.4% vs 5.2%), with a significant reduction in cardiac death (3.0% vs 4.2%). These benefits persisted within 1 year (MACCEs: 5.3% vs 8.3%; cardiac death: 4.5% vs 6.1%), with no significant difference in major bleeding. Meaning: Among patients with STEMI, Tongxinluo improved both 30-day and 1-year clinical outcomes. Importance: Tongxinluo, a traditional Chinese medicine compound, has shown promise in in vitro, animal, and small human studies for myocardial infarction, but has not been rigorously evaluated in large randomized clinical trials. Objective: To investigate whether Tongxinluo could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021. Interventions: Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months (a loading dose of 2.08 g after randomization, followed by the maintenance dose of 1.04 g, 3 times a day), in addition to STEMI guideline-directed treatments. Main Outcomes and Measures: The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year. Results: Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group (relative risk [RR], 0.64 [95% CI, 0.47 to 0.88]; risk difference [RD], −1.8% [95% CI, −3.2% to −0.6%]). Individual components of 30-day MACCEs, including cardiac death (56 [3.0%] vs 80 [4.2%]; RR, 0.70 [95% CI, 0.50 to 0.99]; RD, −1.2% [95% CI, −2.5% to −0.1%]), were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs (100 [5.3%] vs 157 [8.3%]; HR, 0.64 [95% CI, 0.49 to 0.82]; RD, −3.0% [95% CI, −4.6% to −1.4%]) and cardiac death (85 [4.5%] vs 116 [6.1%]; HR, 0.73 [95% CI, 0.55 to 0.97]; RD, −1.6% [95% CI, −3.1% to −0.2%]). There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis (<24 hours; 1-30 days; 1-12 months). More adverse drug reactions occurred in the Tongxinluo group than the placebo group (40 [2.1%] vs 21 [1.1%]; P =.02), mainly driven by gastrointestinal symptoms. Conclusions and Relevance: In patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI. Trial Registration: ClinicalTrials.gov Identifier: NCT03792035 This randomized clinical trial assesses the efficacy of Tongxinluo, a traditional Chinese medicine compound, vs placebo in improving clinical outcomes in patients with ST-segment elevation myocardial infarction. [ABSTRACT FROM AUTHOR]
Copyright of JAMA: Journal of the American Medical Association is the property of American Medical Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Titel: |
Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial.
|
---|---|
Autor/in / Beteiligte Person: | Yang, Yuejin ; Li, Xiangdong ; Chen, Guihao ; Xian, Ying ; Zhang, Haitao ; Wu, Yuan ; Yang, Yanmin ; Wu, Jianhua ; Wang, Chuntong ; He, Shenghu ; Wang, Zhong ; Wang, Yixin ; Wang, Zhifang ; Liu, Hui ; Wang, Xiping ; Zhang, Minzhou ; Zhang, Jun ; Li, Jia ; An, Tao ; Guan, Hao |
Zeitschrift: | JAMA: Journal of the American Medical Association, Jg. 330 (2023-10-24), Heft 16, S. 1534-1545 |
Veröffentlichung: | 2023 |
Medientyp: | academicJournal |
ISSN: | 0098-7484 (print) |
DOI: | 10.1001/jama.2023.19524 |
Schlagwort: |
|
Sonstiges: |
|