Can herbal medicines really improve the prognosis of acute myocardial infarction patients?
Presented in American Heart Association 2022 Science Sessionthe results of the CTS-AMI trial, which evaluated the use of tongxinluo compared with placebo therapy in patients with ST-segment elevation myocardial infarction (STEMI), found that the use of traditional herbal compounds was associated with a 36% relative risk of serious adverse events. showed that it was associated with reduced cardiac and cerebrovascular events, comparable reductions observed for the same endpoint at 1 year.
“These findings support the use of Tongxinluo as an adjunctive therapy in the treatment of STEMI, at least in China and other developing countries,” the researchers wrote.
A renewed interest in the usefulness of Tongxinluo, a traditional Chinese herbal compound approved in China in 1996 as a treatment for angina and stroke, has been shown in the proof-of-concept ENLEAT trial that its use accelerated resolution of the ST segment and It has been on the rise since it was shown that it can minimize the size of myocardial infarction. With this in mind, Yang and his team of colleagues sought to investigate whether tongxinluo could improve clinical outcomes in patients with acute STEMI.
To do this, the Chinese Tongxinluo Study of Cardioplegia in Patients with Acute Myocardial Infarction (CTS-AMI) trial was designed as a multicenter, randomized, double-blind, placebo-controlled trial, with patient-to-patient presentation. The goal is to register within 24 hours of Either tongxinluo or placebo at the same dose.For the purposes of analysis, tongxinluo was administered on his Day 1 at a loading dose of 8 capsules, followed by 4 capsules 3 times daily for 12 months . The researchers noted that both the treatment and control groups received her other STEMI treatment according to guidelines.
The primary outcome of this study was 30-day major cardiovascular and cerebrovascular events (MACCE) defined as a composite of cardiac death, myocardial reinfarction, urgent coronary revascularization, and stroke. The trial also included a number of secondary outcomes, including each component of the primary endpoint, his severe STEMI complications over 30 days, his MACCE over 1 year, readmissions for heart failure, all-cause mortality, and major bleeding. was included.
A total of 4094 patients were enrolled and screened. Of these, 3777 were randomized and included in the investigator’s analysis, 1889 were randomized to tongxinluo and 1888 were randomized to placebo. We noted that there were no significant between-group differences observed regarding therapy (87.67% in the tongxinluo group vs. 86.28% in the placebo group; P.=.21), and other medical procedures.
Analysis showed that the primary outcome event occurred in 3.39% of patients receiving tongxinluo and 5.24% of patients receiving placebo (relative risk [RR]0.64 [95% CI, 0.47-0.88]; P.=.006). When evaluating the individual components of the primary outcome, the results showed that tongxinluo use was associated with a reduction in his 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 that tongxinluo use was associated with a decrease 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), myocardial reinfarction at 1 year (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 showed no significant difference in 1-year all-cause mortality or 30-day and his-year major bleeding compared to placebo therapy.
The study, “Effect of the Chinese Herbal Medicine Tongxinluo in Patients with Acute Myocardial Infarction – Results from the CTS-AMI Trial,” was presented at AHA 22.