TY - JOUR
T1 - 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
AU - Wang, Yongxia
AU - Wang, Xinlu
AU - Wang, Jianru
AU - Li, Chunjie
AU - Zhao, Guoan
AU - Zheng, Chaoyang
AU - Shi, Xiaochi
AU - Wang, Xiaolong
AU - Wang, Ke
AU - Wu, Wei
AU - Zhang, Zhenpeng
AU - Liu, Hengliang
AU - Zhou, Hao
AU - Lin, Fei
AU - Ruan, Xiaofen
AU - Zhao, Jia
AU - Wang, Shichao
AU - Li, Xingyuan
AU - Nie, Shanshan
AU - Li, Xiaohui
AU - Huang, Jinyu
AU - Sun, Heng
AU - Pian, Linping
AU - Xing, Wei
AU - Li, Bin
AU - Yu, Rui
AU - Xing, Zuoying
AU - Song, Yankun
AU - Luo, Yutian
AU - Wang, Duolao
AU - Xie, Yanming
AU - Zhang, Junhua
AU - Zhu, Mingjun
PY - 2024/10/17
Y1 - 2024/10/17
N2 - BackgroundAcute 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.PurposeThe purpose was to assess the effect of TMYX on VR in acute STEMI patients undergoing primary percutaneous coronary intervention (PPCI).Study DesignA multicenter, randomized, double-blinded, and placebo-controlled trial conducted across 11 hospitals in China.MethodA 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.ResultAmong 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).ConclusionTMYX, 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.
AB - BackgroundAcute 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.PurposeThe purpose was to assess the effect of TMYX on VR in acute STEMI patients undergoing primary percutaneous coronary intervention (PPCI).Study DesignA multicenter, randomized, double-blinded, and placebo-controlled trial conducted across 11 hospitals in China.MethodA 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.ResultAmong 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).ConclusionTMYX, 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.
KW - Acute myocardial infarction
KW - Percutaneous coronary intervention
KW - Randomized controlled trial
KW - Tongmai Yangxin pill
KW - Ventricular remodeling
U2 - 10.1016/j.phymed.2024.156133
DO - 10.1016/j.phymed.2024.156133
M3 - Article
SN - 0944-7113
VL - 135
SP - 156133
JO - Phytomedicine
JF - Phytomedicine
M1 - 156133
ER -
