Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention (5C Trial): An Open-Label Randomized Controlled, Multicenter Study.
Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs) plus conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods and Results. Participants (n = 808) with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group) or conventional treatment alone group (control group). All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P = 0.015). The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P = 0.002). No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Shao-Li
SL
Wang
Cheng-Long
CL
Wang
Pei-Li
PL
Wang
Hao
H
Xu
Hong-Ying
HY
Liu
Jian-Peng
JP
Du
Da-Wu
DW
Zhang
Zhu-Ye
ZY
Gao
Lei
L
Zhang
Chang-Geng
CG
Fu
Shu-Zheng
SZ
Lü
Shi-Jie
SJ
You
Jun-Bo
JB
Ge
Tian-Chang
TC
Li
Xian
X
Wang
Guan-Lin
GL
Yang
Hong-Xu
HX
Liu
Jing-Yuan
JY
Mao
Rui-Jie
RJ
Li
Li-Dian
LD
Chen
Shu
S
Lu
Da-Zhuo
DZ
Shi
Ke-Ji
KJ
Chen