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Title: [The effect on myocardial perfusion and clinical outcome of intracoronary nicorandil injection prior to percutaneous coronary intervention in ST-segment elevation myocardial infarction].
Author: Wang ZQ, Chen MX, Liu DL, Zheng WX, Cao XZ, Chen H, Huang MF, Luo ZR.
Journal: Zhonghua Xin Xue Guan Bing Za Zhi; 2017 Jan 25; 45(1):26-33. PubMed ID: 28100342.
Abstract:
Objective: To investigate the effect of intracoronary administration of nicorandil prior to primary percutaneous coronary intervention (PPCI) on myocardial perfusion and short-term clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Methods: A total of 158 patients with STEMI undergoing PPCI from January 2014 to December 2015 in Fuzhou General Hospital were enrolled consecutively in this prospective controlled randomized trial. Patients were assigned into three groups with random number table: the nicorandil group (patients received intracoronary administration of 6 mg nicorandil after guide wire or balloon successfully crossed the target lesion, n=53), the nitroglycerin group (patients received intracoronary administration of 300 μg nitroglycerin after after guide wire or balloon successfully crossed the target lesion, n=52) and the control group(patients received routine treatment, n=53). The primary outcomes were myocardial perfusion, including the levels of corrected TIMI frame count (cTFC), and the incidence of no reflow or slow flow after PPCI. The secondary outcomes included the incidence of major adverse cardiovascular events (MACE) during hospitalization (all-cause death, reperfusion arrhythmia within 2 hours after PPCI, angina within 24 hours after PPCI, new heart failure or worsening cardiac function, and repeat revascularization) and within 3 months of follow-up (all-cause death, nonfatal myocardial infarction, repeat revascularization, post-infarction angina, and re-hospitalization for congestive heart failure). Results: The age of enrolled patients was (62.9±11.3) years old, and 130 cases (82.3%) of them were male. The median time of symptom-onset to balloon was 4.50 (3.20, 6.43) hours. There were significantly difference in cTFC immediately after PPCI((21.68±7.43)frames, (24.74±8.66)frames, and(27.06±10.40)frames), incidence of no reflow or slow flow after PPCI(5.7%(3/53), 13.5%(7/52), and 22.6%(12/53)), ST-segment resolution at 2 hours after procedure(90.6%(48/53), 84.6%(44/52), and 74.5%(38/53)), and reperfusion arrhythmia at 2 hours after procedure(15.1%(8/53), 36.6%(19/52), and 34.0%(18/53)) among the 3 groups(P<0.01 or 0.05). In the multivariate logistic regression models, intracoronary administration of nicorandil could lower the cTFC level (OR=0.17, 95%CI 0.10-0.41, P=0.001), acted as a protecting factor on lowering the incidence of no reflow or slow flow (OR=0.13, 95%CI 0.02-0.96, P=0.045) and reperfusion arrhythmia (OR=0.26, 95%CI 0.09-0.74, P=0.012), as well as facilitating the ST-segment resolution at 2 hours after procedure (OR=4.62, 95%CI 1.14-18.82, P=0.033). However, observed parameters were similar between intracoronary administration of nitroglycerin group compared with control group (all P>0.05). MACE within 3 months of follow-up were similar among the 3 groups(all P>0.05). Conclusion: Intracoronary administration of nicorandil prior to balloon dilation can significantly improve the myocardial perfusion and reduce the occurrence of reperfusion arrhythmia during PPCI for STEMI, but does not affect the short-term prognosis in STEMI patients. 目的： 探讨预防性冠状动脉内注射尼可地尔对急性ST段抬高型心肌梗死(STEMI)患者直接经皮冠状动脉介入治疗(PPCI)术后即刻心肌血流灌注及短期预后的影响。 方法： 采用前瞻性随机对照研究设计，连续入选2014年1月至2015年12月在南京军区福州总医院行PPCI的STEMI患者158例。采用随机数字表法，将患者分为尼可地尔组(在导丝或球囊通过病变后，在冠状动脉内注射尼可地尔6 mg，共53例)、硝酸甘油组(在导丝或球囊通过病变后，冠状动脉内注射硝酸甘油300 μg，共52例)和常规治疗组(直接进行球囊扩张及支架置入，共53例)。主要观察指标为术后即刻心肌血流灌注[包括校正的TIMI血流帧数(cTFC)和无复流或慢血流的发生率]，次要观察指标包括住院期间主要不良心血管事件(包括全因死亡、术后2 h内再灌注心律失常、术后24 h内心绞痛、新发心力衰竭或原有心力衰竭加重和靶血管再次血运重建)和术后3个月主要不良心血管事件(包括全因死亡、再发非致死性心肌梗死、靶血管再次血运重建、梗死后心绞痛和因心力衰竭再入院)。 结果： 患者年龄(62.9±11.3)岁，男性130例(占82.3%)。发病至球囊扩张时间的中位数为4.50(3.20，6.43)h。尼可地尔组、硝酸甘油组和常规治疗组术后即刻cTFC分别为(21.68±7.43)帧、(24.74±8.66)帧和(27.06±10.40)帧，术后发生无复流或慢血流比例分别为5.7%(3/53)、13.5%(7/52)和22.6%(12/53)，术后2 h内ST段回落比例分别为90.6%(48/53)、84.6%(44/52)和74.5%(38/53)，术后2 h内再灌注心律失常发生率分别为15.1%(8/53)、36.6%(19/52)和34.0%(18/53)，3组之间差异均有统计学意义(P<0.01或0.05)。多因素logistic回归分析显示，与常规治疗比较，应用尼可地尔可以降低术后即刻cTFC值(OR＝0.17，95%CI 0.10～0.41，P＝0.001)，是术后发生无复流或慢血流(OR＝0.13，95%CI 0.02～0.96，P＝0.045)和住院期间发生再灌注心律失常(OR＝0.26，95%CI 0.09～0.74，P＝0.012)的保护因素，并可以促进术后2 h内心电图ST段回落(OR＝4.62，95%CI 1.14～18.82，P＝0.033)；应用硝酸甘油对术后即刻cTFC、发生无复流或慢血流、术后2 h内ST段回落和住院期间发生再灌注心律失常均无影响(P均>0.05)。术后3个月主要不良心血管事件比例3组之间差异均无统计学意义(P均>0.05)。 结论： PPCI术前预防性冠状动脉内注射尼可地尔可以改善STEMI患者术后即刻心肌血流灌注水平，减少再灌注心律失常的发生，但并不改善短期预后。.

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