Chunguang Feng1, Yi Liu2, Lulu Wang2, Dongdong Niu2, Bing Han2. 1. Department of Cardiology, Central Hospital of Xuzhou, Xuzhou Institute of Cardiovascular Disease, Xuzhou City 221009, Jiangsu Province, China. Electronic address: fcg999@163.com. 2. Department of Cardiology, Central Hospital of Xuzhou, Xuzhou Institute of Cardiovascular Disease, Xuzhou City 221009, Jiangsu Province, China.
Abstract
BACKGROUND: To determine whether nicorandil administration distal to the thrombus in the coronary artery during percutaneous coronary intervention (PCI) in acute ST-segment elevation myocardial infarction (STEMI) patients reduced the incidence of no-reflow phenomenon, reperfusion injury, and adverse events. METHODS: This randomised controlled trial involved 170 STEMI patients who underwent PCI. All patients underwent thrombectomy and tirofiban injection (10μg/kg) distal to the vascular lesion via a suction catheter, followed by nicorandil (84 patients; 2mg) or saline injection (86 patients; 2mL) at the same site. The primary endpoint (major adverse cardiac events, MACEs) was 6-month cardiovascular mortality or unplanned readmission rate due to worsening congestive heart failure. The secondary endpoints were thrombolysis in myocardial infarction (TIMI) grade, TIMI myocardial perfusion grade (TMPG), resolution of ST-segment elevation (defined as >50% decrease in ST elevation); and ventricular arrhythmias. RESULTS: Upon Kaplan-Meier analysis, freedom from MACEs was 92.9% in the nicorandil group and 81.4% in the placebo (p=0.026). The numbers of patients achieving TIMI grade 3 (95.24% vs. 86.05%; p=0.040) and TMPG 3 (94.05% vs. 83.72%; p=0.033) were greater in the nicorandil group than in the control group. Resolution of ST-segment elevation occurred in 84.52% and 68.60% patients in the nicorandil and control groups, respectively (p=0.014). Ventricular arrhythmias occurred in 5.95% and 16.28% patients in the nicorandil and control groups, respectively (p=0.032). CONCLUSIONS: Early administration of nicorandil distal to the vascular lesion during PCI in STEMI patients may reduce the incidence of reperfusion injury, and improve short-term clinical outcomes. TRIAL REGISTRATION NUMBER: NCT02435797.
RCT Entities:
BACKGROUND: To determine whether nicorandil administration distal to the thrombus in the coronary artery during percutaneous coronary intervention (PCI) in acute ST-segment elevation myocardial infarction (STEMI) patients reduced the incidence of no-reflow phenomenon, reperfusion injury, and adverse events. METHODS: This randomised controlled trial involved 170 STEMI patients who underwent PCI. All patients underwent thrombectomy and tirofiban injection (10μg/kg) distal to the vascular lesion via a suction catheter, followed by nicorandil (84 patients; 2mg) or saline injection (86 patients; 2mL) at the same site. The primary endpoint (major adverse cardiac events, MACEs) was 6-month cardiovascular mortality or unplanned readmission rate due to worsening congestive heart failure. The secondary endpoints were thrombolysis in myocardial infarction (TIMI) grade, TIMI myocardial perfusion grade (TMPG), resolution of ST-segment elevation (defined as >50% decrease in ST elevation); and ventricular arrhythmias. RESULTS: Upon Kaplan-Meier analysis, freedom from MACEs was 92.9% in the nicorandil group and 81.4% in the placebo (p=0.026). The numbers of patients achieving TIMI grade 3 (95.24% vs. 86.05%; p=0.040) and TMPG 3 (94.05% vs. 83.72%; p=0.033) were greater in the nicorandil group than in the control group. Resolution of ST-segment elevation occurred in 84.52% and 68.60% patients in the nicorandil and control groups, respectively (p=0.014). Ventricular arrhythmias occurred in 5.95% and 16.28% patients in the nicorandil and control groups, respectively (p=0.032). CONCLUSIONS: Early administration of nicorandil distal to the vascular lesion during PCI in STEMI patients may reduce the incidence of reperfusion injury, and improve short-term clinical outcomes. TRIAL REGISTRATION NUMBER: NCT02435797.
Authors: Weiding Wang; Xu Zhang; Kangyin Chen; Li Yin; Mengqi Gong; Yang Liu; Gary Tse; Lin Wu; Guangping Li; Tong Liu Journal: Ann Noninvasive Electrocardiol Date: 2019-12-17 Impact factor: 1.468