Shuai Mao1,2, Lei Wang1,2, Xujie Zhao1,2, Liheng Guo1,2, Qian Lin3, Xiaofeng Wang4, Xiaohua Dai5, Hongcai Shang6, Minzhou Zhang7,8,9, Aleksander Hinek10. 1. Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China. 2. AMI Key lab of Chinese Medicine in Guangzhou, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. 3. Dongfang Hospital of Beijing University of Chinese Medicine, Beijing, China. 4. Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China. 5. First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China. 6. Key Laboratory of Chinese Internal Medicine of ME and Beijing, Beijing University of Chinese Medicine, Beijing, China. 7. Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China. minzhouzhang@aliyun.com. 8. AMI Key lab of Chinese Medicine in Guangzhou, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. minzhouzhang@aliyun.com. 9. 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Yuexiu District, Guangzhou, 510120, China. minzhouzhang@aliyun.com. 10. Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, Canada.
Abstract
BACKGROUND: Sodium tanshinone IIA sulfonate (STS) has been widely used by Chinese medicine practitioners for chronic cardiovascular diseases. However, its direct clinical efficacy in patients with acute coronary syndrome following percutaneous coronary intervention (PCI) has not been reported yet. The present trial aimed to investigate potential cardioprotection of STS in patients undergoing PCI for non-ST elevation acute coronary syndrome (NSTE-ACS). METHODS: In a randomized, double-blind, placebo-controlled trial, 372 patients with NSTE-ACS were randomly assigned to receive STS (n = 192) or saline (n = 180) for 2 days before and 3 days after PCI along with standard therapy. The primary endpoint was the composite incidence of major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, repeated revascularization of the target vessel, and stent thrombosis, within 30 days after PCI. RESULTS: The 30-day MACEs occurred in 18.8% of the patients in the STS group and in 27.2% of the patients in the control group (P = 0.038); this difference was mostly driven by reduction of myocardial infarction incidence (17.2% vs. 26.7%, P = 0.027). Post-procedural elevation of troponin-I was also significantly lower in the STS group (26.56% vs. 47.78%, P < 0.001). Multivariable analysis identified STS as a predictor of decreased risk of MACE occurrence (odds ratio: 0.60, 95% confidence interval: 0.36 to 0.99; P = 0.045). CONCLUSION: Addition of STS to the standard treatments recommended by the current practice guidelines in patients with NSTE-ACS undergoing PCI could reduce myocardial injury and the occurrence of short-term cardiovascular events, primarily driven by non-fatal myocardial infarction. TRIAL REGISTRATION: ChiCTR-TRC-14005182.
BACKGROUND: Sodium tanshinone IIA sulfonate (STS) has been widely used by Chinese medicine practitioners for chronic cardiovascular diseases. However, its direct clinical efficacy in patients with acute coronary syndrome following percutaneous coronary intervention (PCI) has not been reported yet. The present trial aimed to investigate potential cardioprotection of STS in patients undergoing PCI for non-ST elevation acute coronary syndrome (NSTE-ACS). METHODS: In a randomized, double-blind, placebo-controlled trial, 372 patients with NSTE-ACS were randomly assigned to receive STS (n = 192) or saline (n = 180) for 2 days before and 3 days after PCI along with standard therapy. The primary endpoint was the composite incidence of major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, repeated revascularization of the target vessel, and stent thrombosis, within 30 days after PCI. RESULTS: The 30-day MACEs occurred in 18.8% of the patients in the STS group and in 27.2% of the patients in the control group (P = 0.038); this difference was mostly driven by reduction of myocardial infarction incidence (17.2% vs. 26.7%, P = 0.027). Post-procedural elevation of troponin-I was also significantly lower in the STS group (26.56% vs. 47.78%, P < 0.001). Multivariable analysis identified STS as a predictor of decreased risk of MACE occurrence (odds ratio: 0.60, 95% confidence interval: 0.36 to 0.99; P = 0.045). CONCLUSION: Addition of STS to the standard treatments recommended by the current practice guidelines in patients with NSTE-ACS undergoing PCI could reduce myocardial injury and the occurrence of short-term cardiovascular events, primarily driven by non-fatal myocardial infarction. TRIAL REGISTRATION: ChiCTR-TRC-14005182.
Authors: Glenn N Levine; Eric R Bates; James C Blankenship; Steven R Bailey; John A Bittl; Bojan Cercek; Charles E Chambers; Stephen G Ellis; Robert A Guyton; Steven M Hollenberg; Umesh N Khot; Richard A Lange; Laura Mauri; Roxana Mehran; Issam D Moussa; Debabrata Mukherjee; Brahmajee K Nallamothu; Henry H Ting Journal: Circulation Date: 2011-11-07 Impact factor: 29.690