Efficacy and safety of nicorandil on perioperative myocardial injury in patients undergoing elective percutaneous coronary intervention: results of the PENMIPCI trial

Abstract

BackgroundPrevious studies have indicated that nicorandil can reduce perioperative myocardial injury (PMI) in patients undergoing elective percutaneous coronary intervention (ePCI), but this conclusion is still controversial. Additionally, studies reporting on the safety of nicorandil are lacking. Therefore, we performed this prospective study to evaluate the efficacy and safety of nicorandil on PMI in patients undergoing ePCI.MethodsOne hundred and forty-six patients with coronary heart disease (CHD) scheduled to undergo ePCI were randomly assigned to the nicorandil group (n=74) or control group (n=72). The primary outcomes were the change in cardiac troponin T (cTnT) and creatine kinase-MB (CK-MB) at 12 and 24 hours after surgery. The secondary outcome was the incidence of major adverse cardiac events (MACE), which was a composite of cardiac death, nonfatal myocardial infarction, new heart failure or coronary revascularization.ResultsThere was no difference in age (54.76±5.93 vs 56.35±5.22) between the nicorandil group and the control group. In addition, no differences were observed in the cTnT and CK-MB levels between the two groups at admission (all P⩾0.05). Compared with those in the control group, the cTnT (0.15±0.12 vs 0.12±0.10 at 12 hours and 0.17±0.12 vs 0.13±0.10 at 24 hours) and CK-MB (15.35±8.23 vs 12.31±7.93 at 12 hours and 13.63±8.87 vs 11.13±5.71 at 24 hours) levels in the nicorandil group were significantly decreased after surgery (all P⩽0.05). Furthermore, nicorandil did not increase the incidence of MACE in the nicorandil group compared with the control group (12.16% vs 12.50%).ConclusionsNicorandil can reduce PMI in patients undergoing ePCI and does not increase the incidence of MACE.Clinical Trial RegistrationURL: http://www.chictr.org.cn/. Unique Identifier: ChiCTR-IOR-17012056.

The Efficacy and Safety of Nicorandil for Periprocedural Myocardial Injury in Patients Undergoing PCI: A Meta-Analysis

“…Additional studies were removed by screening of the full text. Finally, 15 articles [ 18 – 32 ] (16 trial comparisons) were enrolled which comprised 2221 patients ( Figure 1 ). Overall, there were 1130 patients (50.9%) who received nicorandil and 1091 patients (49.1%) in the control group.…”

“…All studies were randomized controlled trials. 15 studies [ 18 – 32 ] provided the process of randomization. Two studies [ 21 , 23 ] mentioned blinding of personnel and subjects.…”

“…Fourteen studies [ 18 – 32 ] (15 trial comparisons) reported MACE. In total, 137 out of 1097 patients in the nicorandil group experienced MACE, while 192 out of 1062 patients in the control group experienced PMI.…”

Efficacy and Safety of Nicorandil for Periprocedural Myocardial Injury in Patients Undergoing Pci

“…In any case, periprocedural myocardial injury (PMI) continues to address a significant clinical challenge in patients undergoing PCI, contributing to adverse cardiovascular outcomes (1). Nicorandil, a therapeutic solution combining ATP-sensitive potassium channel opener and nitric oxide donor, is attracting particular attention because of its vasodilating properties and protection from hypoxia (2). Despite the performance of nicorandil's promising pre-clinical testing, the effectiveness and safety of nicorandil in playing the role of primary mental infarction in patients undertaking coronary angioplasty is still unknown.…”