Key Points:
- Tongxinluo (TXL) is a traditional Chinese medicine with endothelial-protective effects which has been used for angina and stroke prevention in China. It has yet to be tested as a means of improving clinical outcomes in acute STEMI.
- In the CTS-MI study, patients presenting with STEMI were randomized to either TXL (at randomization, and then continued for a year) or placebo. The primary outcome of interest was 30-day MACCE, a composite of cardiovascular mortality, recurrent MI, stroke, and emergent coronary revascularization. Secondary outcomes included 1-year MACCE as well as the individual components of MACCE, severe MI complications, and adverse events.
- TXL use resulted in a 36% reduction of MACCE at 30-days and 1-year, as well as reduced severe STEMI complications. TXL use was safe, with no increase in adverse events.
Tongxinluo (TXL), a Chinese traditional medicine compound, has been used in angina and stroke in China since 1996 for its endothelial-protective effects. A recent proof-of-concept trial demonstrated that TXL could accelerate ST-segment resolution and minimize MI size in STEMI patients; however, there has yet to be an RCT directly examining its clinical effects. In a breaking presentation at the 2022 AHA Scientific Sessions today, Dr. Yue-Jin Yang (Chinese Academy of Medical Sciences and Peking Union Medical College) and his team presented their study: “The Impact of Chinese Herbal Medicine, Tongxinluo in Patients with Acute Myocardial Infarction,” or the CTS-MI trial.
The CTS-MI study was a multi-center, double-blind randomized clinical trial conducted across 124 hospitals in China which evaluated the effects of TXL (as an adjunct to guideline recommended medications) against placebo in patients presenting with STEMI. Patients receiving TXL would receive 2.08g at the time of randomization, followed by 1.04g TID for 12 months. The inclusion criteria comprised any adults presenting with STEMI who underwent either primary PCI, thrombolysis, or medical management. A total of 3777 patients were randomized. The mean age was 61, and 23% of patients were female. The cohort was composed of 22% diabetics, and 48% had an anterior MI. For reperfusion strategy, 6% underwent thrombolysis, 93% underwent primary PCI, and 1% underwent CABG.
The primary outcome was 30-day MACCE (including cardiac death, repeat MI, stroke, and emergent coronary revascularization), which was reduced 36% in the TXL group (RR 0.64, 95% CI 0.47-0.88; p=0.006). MACCE was also reduced in the TXL group at 1-year (HR 0.64, 95% CI 0.49-0.82; p<0.001). Secondary outcomes including 30-day cardiac death (RR 0.70, 95% CI 0.50-0.99; p=0.04) and 30-day myocardial re-infarction (RR 0.35, 95% CI 0.13-0.99; p=0.003) were also significantly reduced in the TXL group. Additionally, 30-day severe STEMI complications (including acute heart failure and mechanical complications) were reduced in the TXL group (RR 0.80, 95% CI 0.68-0.94; p=0.008), as well as malignant arrythmias (RR 0.77, 95% CI 0.62-0.94; p=0.011). There was no increase in any (or serious) adverse events in the TXL group. Renal injury was increased in the placebo group (3.81% vs 5.30%, p = 0.029).
When discussing the clinical implications of the study at AHA, Dr. Yang stated: “Tongxinluo (TXL), a traditional Chinese medicine, significantly improves both the 30-day and 1-year clinical outcomes of Chinese patients with STEMI, especially reducing cardiac death and severe STEMI complications. TXL did not result in severe side effects…these findings support the use of TXL as an adjunct therapy in treating STEMI, at least in China and other developing countries.”