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Prophylactically injection of Nicorandil to reduce no-reflow phenomenon during PCI in acute STEMI patients: Protocol of a double-blinded, randomized, placebo-controlled trial.
An, S, Huang, H, Wang, H, Jiang, Y
Medicine. 2021;(15):e25500
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Abstract
INTRODUCTION An acute ST-elevation myocardial infarction (STEMI) is a very serious type of heart attack and a profoundly life-threatening medical emergency, and percutaneous coronary intervention (PCI) is the preferred strategy. However, in patients undergoing primary PCI, 30% to 40% may suffer the no-reflow phenomenon (NRP), and it could expand the myocardial infarction area and accompanied with high rehospitalization rate and fatality rate. In this study, we try to conduct a double blinded, randomized, placebo-controlled trial to observe whether the prophylactically intracoronary administration of Nicorandil could reduce the occurrence of NRP in STEMI patients undergoing PCI. METHODS Simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2010 to divide the patients to treatment group (Nicorandil) and control group (Saline). The outcomes are the occurrence of NRP, levels of interleukin-6 and HS-CRP, cTnT, and CK-MB before, and every 4 hours following PCI, and major adverse cardiovascular events at day 30. SPSS 23.0 (IBM, Chicago, IL) will be used, and P-value < .05 will be considered statistically significant. CONCLUSIONS The findings will determine the efficacy of prophylactically intracoronary administration of Nicorandil to reduce the occurrence of NRP during PCI in acute STEMI patients. TRIAL REGISTRATION OSF Registration number: DOI 10.17605/OSF.IO/QPF3V.
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Nicorandil for Periprocedural Myocardial Injury in Elective Percutaneous Coronary Intervention: A Meta-Analysis of 10 Randomized Controlled Trials.
Yi, B, Luo, J, Jiang, Y, Mo, S, Xiao, X, Chen, X, Rong, J
Angiology. 2020;(7):609-615
Abstract
The clinical outcomes of nicorandil in percutaneous coronary intervention (PCI) are conflicting. We sought to evaluate the effects of nicorandil on periprocedural myocardial injury (PMI) in elective PCI. Eligible studies that reported the effect of nicorandil on PMI in elective PCI were obtained from PubMed, Web of Science, and Cochrane Library (up to October 28, 2019). The outcomes were PMI and major adverse cardiovascular and cerebrovascular events (MACCEs). Ten randomized controlled trials with 1304 patients undergoing elective PCI were evaluated. Nicorandil significantly reduced the incidence of PMI (odds ratio [OR] = 0.48; P = .0003); however, there was no significant difference in MACCEs (OR = 0.80; P = .45) between the 2 groups. Subgroup analyses showed that nicorandil significantly lowered the PMI risk when only patients with stable coronary artery disease (OR = 0.41; P = .0008) were considered and when nicorandil was administered intravenously (OR = 0.41; P = .0007) or orally (OR = 0.33; P = .0001). This meta-analysis suggests that nicorandil could reduce the incidence of PMI without increasing the occurrence of MACCEs in elective PCI. The effect of nicorandil in lowering the PMI risk is associated with the diagnosis of the patients and the route of nicorandil administration.