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      Nicorandil prior to primary percutaneous coronary intervention improves clinical outcomes in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials [Letter]

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      Drug Design, Development and Therapy

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          Abstract

          Dear editor Early myocardial revascularization by the primary percutaneous coronary intervention (PPCI) was an important treatment for patients with ST-segment elevated myocardial infarction (STEMI); thus, a proportion of STEMI subjects still have impaired cardiac function and increased cardiovascular mortality. Recently, we read with great interest the study by Xu et al.1 The authors performed a meta-analysis to evaluate the effectiveness of the administration of nicorandil during percutaneous coronary intervention in patients with acute myocardial infarction. They concluded that periprocedural nicorandil improves coronary blood flow, cardiac systolic function and prognosis in STEMI patients receiving primary PCI. The research appears informative clinically. Thus, we addressed some issues regarding this study. Firstly, although the heterogeneity was not detected according to the statistical methodology, the clinical heterogeneity was still observed between the included studies because of the different routes of nicorandil administration (such as intracoronary injection and intravenous nicorandil). Therefore, the random model should be selected to estimate the results. Secondly, Xu et al used the main adverse cardiac events (MACEs) as the hard points although the definition of MACE between the studies was not consistent.1 For instance, the study by Ishii et al defined the MACE as the composite of all-cause mortality and all-cause admission,2 while Feng et al described the MACE as the composite of cardiovascular death or unplanned readmission due to worsening congestive heart failure (HF).3 Moreover, Xu et al define the MACE in this meta-analysis as the composite outcomes of all-cause death, target vessel revascularization, recurrent angina or myocardial infarction, stroke and severe HF.1 In this situation, the study conducted by Fujiwara et al did not report the MACE events.4 Thus, Xu et al regarded the in-stent restenosis as the MACE event (in-stent restenosis occurred in 9 patients in the nicorandil group and 10 in the control group, respectively), which was the violation of the predefined protocol. Therefore, the conclusion that the administration of nicorandil can improve the clinical outcome was misleading. Thirdly, we are confused about the study by Feng et al. We found that they publish another report of the same trial (both are registered in the clinicaltrial.gov, the trial registration number was NCT02435797).5 However, in that report the total number of included patients was 120; thus, the number was 170 in another report. We believe that the authors should identify the difference between these two reports and confirm the authenticity of the study before included this confusing research in the meta-analysis. Lastly, the incidence of headache was not fewer after taking the nicorandil. Patients with acute myocardial infarction usually take the nitrates to improve myocardial ischemia after PCI. Thus, the combination of nitrates and nicorandil may increase the risk of headache, which may reduce patients’ therapeutic compliance. Therefore, the authors should comprehensively evaluate the efficacy and safety of the nicorandil.

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          Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment-elevation myocardial infarction.

          Intravenous nicorandil, a hybrid compound of ATP-sensitive potassium channel opener and nitric oxide donor, has been reported to ameliorate early functional and clinical problems in patients with acute myocardial infarction. However, its effects on the late phase remain unclear. This follow-up study to 5 years of a randomized, double-blinded trial was conducted among 368 patients with first ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). They were randomly assigned to receive 12 mg of nicorandil or a placebo intravenously just before reperfusion. We analyzed incidence of cardiovascular death or rehospitalization for congestive heart failure after PCI as well as various aspects of epicardial flow and microvascular function. Mean follow-up was 2.4 years (SD, 1.4). A total of 12 (6.5%) patients receiving nicorandil and 30 (16.4%) receiving placebo had cardiovascular death or hospital admission for congestive heart failure (hazard ratio, 0.39; 95% CI, 0.20 to 0.76; P=0.0058). Postprocedural TIMI 3 flow was obtained in 89.7% of the nicorandil group and in 81.4% of the placebo (hazard ratio, 1.99; 95% CI, 1.09 to 3.65; P=0.025). Corrected TIMI frame count was furthermore lower in the nicorandil group (21.0+/-9.1 versus 25.1+/-14.1; P=0.0009). ST-segment resolution >50% was observed in 79.5% and 61.2% of the nicorandil and placebo groups, respectively (hazard ratio, 2.45; 95% CI, 1.54 to 3.90; P=0.0002). The addition of intravenous nicorandil to PCI leads to beneficial clinical outcomes and prevents cardiovascular events of long duration and death in patients with ST-segment-elevation myocardial infarction.
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            Effects of Early Intracoronary Administration of Nicorandil During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

            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.
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              Nicorandil suppresses the increases in plasma level of matrix metalloproteinase activity and attenuates left ventricular remodeling in patients with acute myocardial infarction.

              Nicorandil, a hybrid KATP channel opener and nicotinamide nitrate, reduces no-reflow phenomenon and improves cardiac function in patients with acute myocardial infarction (AMI). We reported that nicorandil suppresses radical formation in patients with AMI undergoing primary percutaneous coronary intervention (PCI). In the present study, we tested the hypothesis that nicorandil treatment suppresses MMP activities and predicts ventricular remodeling in AMI. Sixty-two patients with AMI were randomized into nicorandil pretreatment (n = 31) and control (n = 31) groups after admission and underwent primary PCI. Nicorandil was administered as a bolus injection (4 mg) followed by constant infusion (8 mg/h) for 24 h just after admission. On days 1, 2, and 14 after the onset of AMI, the plasma levels of matrix metalloproteinase (MMP)-2 and MMP-9 were measured by enzyme-linked immunosorbent assay and the activities by gelatin zymography. There were no differences in the baseline clinical characteristics between the two groups. On day 1, there were no differences in both MMP-2 and MMP-9 levels and their activities between the two groups. However, both MMP-2 and MMP-9 levels and their activities were significantly lower in nicorandil than in control group on day 2 (MMP-2 level, 1 014 +/- 39 vs 1 174 +/- 44 ng/ml; MMP-9 level, 17 +/- 1 vs 23 +/- 2 ng/ml; both P < 005) and on day l4 (MMP-2 level, 970 +/- 38 vs 1 221 +/- 44 ng/ml; MMP-9 level, 17 +/- 1 vs 23 +/- 1 ng/ml; both P < 0.05). Left ventricular end-diastolic volume index (LVEDVI) at acute phase was not different between the two groups. At 6 months after AMI, LVEDVI was significantly smaller in nicorandil than in the control group (83 +/- 4 vs 96 +/- 4 ml/m2, P < 0.05). The change in LVEDVI from acute phase to 6 months was positively correlated with MMP-2 and MMP-9 levels and activities. Nicorandil suppresses the increases in MMP levels and activities and prevents the development of ventricular remodeling in AMI.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                DDDT
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                13 August 2019
                2019
                : 13
                : 2825-2826
                Affiliations
                [1 ] Department of Cardiology, The Second Clinical Medical College of Jinan University, Shenzhen People’s Hospital , Shenzhen 518020, People’s Republic of China
                Author notes
                Correspondence: Aixia LuDepartment of Cardiology, The Second Clinical Medical College of Jinan University, Shenzhen People’s Hospital , N0.1017 Dongmen North Road, Shenzhen518020, People’s Republic of ChinaTel +86 755 2553 3018Fax +86 755 2553 3497 Email luaixiashenzhen@163.com
                Article
                215061
                10.2147/DDDT.S215061
                6698177
                © 2019 Li et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                References: 5, Pages: 2
                Categories
                Letter

                Pharmacology & Pharmaceutical medicine

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