A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to evaluate the effect of Tongmai Yangxin Pill on ventricular remodeling in acute anterior STEMI patients after Primary PCI

Wang, Yongxia, Wang, Xinlu, Wang, Jianru, Li, Chunjie, Zhao, Guoan, Zheng, Chaoyang, Shi, Xiaochi, Wang, Xiaolong, Wang, Ke, Wu, Wei, Zhang, Zhenpeng, Liu, Hengliang, Zhou, Hao, Lin, Fei, Ruan, Xiaofen, Zhao, Jia, Wang, Shichao, Li, Xingyuan, Nie, Shanshan, Li, Xiaohui, Huang, Jinyu, Sun, Heng, Pian, Linping, Xing, Wei, Li, Bin, Yu, Rui, Xing, Zuoying, Song, Yankun, Luo, Yutian, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Xie, Yanming, Zhang, Junhua and Zhu, Mingjun (2024) 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to evaluate the effect of Tongmai Yangxin Pill on ventricular remodeling in acute anterior STEMI patients after Primary PCI'. Phytomedicine, Vol 135, p. 156133.

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Abstract

Background
Acute ST-segment elevation myocardial infarction (STEMI) is a severe form of coronary heart disease and a leading cause of mortality and morbidity. This can mainly be ascribed to adverse ventricular remodeling (VR). However, the efficacy of existing treatment strategies for STEMI is not entirely satisfactory. Tongmai Yangxin Pill (TMYX), a patented traditional Chinese medicine (TCM), has been approved for treating various cardiovascular diseases.

Purpose
The purpose was to assess the effect of TMYX on VR in acute STEMI patients undergoing primary percutaneous coronary intervention (PPCI).

Study Design
A multicenter, randomized, double-blinded, and placebo-controlled trial conducted across 11 hospitals in China.

Method
A total of 270 patients with acute anterior STEMI, undergoing PPCI within 10 days of symptom onset were enrolled and randomly assigned to receive either a placebo or TMYX, in addition to guideline-directed treatments for STEMI. The primary endpoint was a change in left ventricular end-diastolic volume index (LVEDVI) at 12 weeks.

Result
Among the 270 randomized patients, 218 (TMYX: 109 and placebo: 109) were included in the per-protocol analysis. At 4 and 12 weeks, TXMY significantly improved LVEDVI than the placebo group ([-2.17(-9.24, 8.28) vs. 3.76(-2.38, 11.48), p < 0.05] and [-1.17 (-12.19, 12.88) vs. 4.46 (-2.89, 11.99), p < 0.05]). Changes in left ventricular end-diastolic volume (LVEDV) at 4 weeks were superior in the TMYX group than the placebo group (-4.37 (-17, 13.99) vs. 7.41 (-4.56, 21.79), p < 0.05). Cardiac magnetic resonance imaging (CMRI) showed that left ventricular ejection fraction (LVEF) was significantly greater in the TMYX group than in the placebo group at 4 weeks. There were no statistically significant differences between groups for left ventricular end-systolic volume (LVESV), left ventricular end-systolic volume index (LVESVI), 6 min walking distance (6MWD), and major adverse cardiac and cerebrovascular events (MACCEs) (p > 0.05).

Conclusion
TMYX, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly delayed VR in patients with acute anterior STEMI undergoing PPCI within 10 days of symptom onset.

Item Type:	Article
Subjects:	WB Practice of Medicine > Therapeutics > WB 377 Spinal, cisternal and ventricular puncture WG Cardiovascular System > WG 120 Cardiovascular diseases
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1016/j.phymed.2024.156133
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	06 Nov 2024 14:19
Last Modified:	06 Nov 2024 14:19
URI:	https://archive.lstmed.ac.uk/id/eprint/25487

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