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Could Chinese herbal medicine really improve the prognosis of patients with acute myocardial infarction? According to the CTS-AMI, that is exactly the case.
Presented at the American Heart Association 2022 Scientific Sessions, results of the CTS-AMI trial, which assessed use of tongxinluo compared against placebo therapy in patients with ST-elevated myocardial infarction (STEMI), indicate use of the traditional herbal compound was associated with a 36% reduction in relative risk of major adverse cardiac and cerebrovascular events, with a comparable reduction observed for the same endpoint at 1-year.
“These findings support the use of tongxinluo, as an adjunct therapy, in treating STEMI, at least in China and other developing countries,” wrote investigators.
A traditional Chinese medicine compound with approvals dating back to 1996 in China for angina and stroke, a renewed interest in utility of tongxinluo has grown since the proof-of-concept ENLEAT trial demonstrated use could accelerate ST segment resolution and minimize myocardial infarction size. With this in mind, Yang and a team of colleagues sought to explore whether or not tongxinluo could improve clinical outcomes in patients with acute STEMI.
To do so, the China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI) trial was designed as a multicenter randomized, double-blinded, placebo-controlled trial with the aim of enrolling patients within 24 hours of presentation to either tongxinluo or the same doses of placebo. For the purpose of analysis, tongxinluo was administered with a loading dose of 8 capsules on day 1, followed by 4 capsules 3 times a day until 12 months. Investigators noted both the treatment and control group received other guideline-directed STEMI treatments.
The primary outcome of interest for the study was 30-day major adverse cardiovascular and cerebrovascular events (MACCE), which was defined as a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. The trial also included a multitude of secondary outcomes, such as each component of the primary end point, 30-day severe STEMI complications, 1-year MACCE, rehospitalization due to heart failure, all-cause mortality, and major bleeding.
A total of 4094 patients were registered and screened. Of these, 3777 underwent randomization and were included in the investigators’ analysis, with 1889 randomized to tongxinluo and 1888 randomized to placebo. Investigators noted there were no major between-group differences observed regarding baseline characteristics, emergent reperfusion therapy (87.67% in tongxinluo group vs 86.28% in placebo group; P=.21), and other medical treatments.
Upon analysis, results indicated a primary outcome event occurred among 3.39% of patients receiving tongxinluo and 5.24% of patients receiving placebo therapy (Relative Risk [RR], 0.64 [95% CI, 0.47-0.88]; P=.006). When assessing individual components of the primary outcome, results indicated use of tongxinluo was associated with a reduction in 30-day cardiac death (RR, 0.70 [95% CI, 0.50-0.99]; P=.04), 30-day myocardial reinfarction (RR, 0.35 [95% CI, 0.13-0.99]; P=.003), and 30-day stroke (RR, 0.44 [95% CI, 0.14-1.43]; P=.161).
Further analysis suggested use of tongxinluo was associated with reduction in 1-year MACCE (HR, 0.64 [95% CI, 0.49-0.82]; P <.001), 1-year cardiac death (HR, 0.73 [95% CI, 0.55-0.97]; P=.03), 1-year myocardial reinfarction (HR, 0.26 [95% CI, 0.10-0.67]; P=.005), and 1-year stroke (HR, 0.44 [95% CI, 0.21-0.92]; P=.03). Analysis of safety endpoints demonstrated there was no significant difference in 1-year all-cause mortality or major bleeding at 30 days and 1 year compared with placebo therapy.
This study, “The Impact of Chinese Herbal Medicine, Tongxinluo in Patients With Acute Myocardial Infarction—Results From the CTS-AMI Trial,” was presented at AHA 22.