Efficacy and safety of nicorandil on perioperative myocardial injury in patients undergoing elective percutaneous coronary intervention: results of the PENMIPCI trial
Authors Ye Z, Lu H, Su Q, Long M, Li L
Received 12 May 2018
Accepted for publication 27 June 2018
Published 22 August 2018 Volume 2018:12 Pages 2591—2599
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Anastasios Lymperopoulos
Ziliang Ye,1 Haili Lu,2 Qiang Su,1 Manyun Long,1 Lang Li1
On behalf of the PENMIPCI investigators
1Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People’s Republic of China; 2Department of Orthodontics, The Affiliated Dental Hospital of Guangxi Medical University, Nanning, Guangxi, People’s Republic of China
Background: Previous 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.
Methods: One 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.
Results: There 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%).
Conclusions: Nicorandil can reduce PMI in patients undergoing ePCI and does not increase the incidence of MACE.
Clinical Trial Registration: URL: http://www.chictr.org.cn/. Unique Identifier: ChiCTR-IOR-17012056.
Keywords: nicorandil, perioperative myocardial injury, elective percutaneous coronary intervention
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