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Nicorandil for Periprocedural Myocardial Injury in Elective Percutaneous Coronary Intervention: A Meta-Analysis of 10 Randomized Controlled Trials.
Yi, B, Luo, J, Jiang, Y, Mo, S, Xiao, X, Chen, X, Rong, J
Angiology. 2020;(7):609-615
Abstract
The clinical outcomes of nicorandil in percutaneous coronary intervention (PCI) are conflicting. We sought to evaluate the effects of nicorandil on periprocedural myocardial injury (PMI) in elective PCI. Eligible studies that reported the effect of nicorandil on PMI in elective PCI were obtained from PubMed, Web of Science, and Cochrane Library (up to October 28, 2019). The outcomes were PMI and major adverse cardiovascular and cerebrovascular events (MACCEs). Ten randomized controlled trials with 1304 patients undergoing elective PCI were evaluated. Nicorandil significantly reduced the incidence of PMI (odds ratio [OR] = 0.48; P = .0003); however, there was no significant difference in MACCEs (OR = 0.80; P = .45) between the 2 groups. Subgroup analyses showed that nicorandil significantly lowered the PMI risk when only patients with stable coronary artery disease (OR = 0.41; P = .0008) were considered and when nicorandil was administered intravenously (OR = 0.41; P = .0007) or orally (OR = 0.33; P = .0001). This meta-analysis suggests that nicorandil could reduce the incidence of PMI without increasing the occurrence of MACCEs in elective PCI. The effect of nicorandil in lowering the PMI risk is associated with the diagnosis of the patients and the route of nicorandil administration.
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The effect of nicorandil in patients with cardiac syndrome X: A meta-analysis of randomized controlled trials.
Jia, Q, Shi, S, Yuan, G, Shi, J, Shi, S, Wei, Y, Hu, Y
Medicine. 2020;(37):e22167
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BACKGROUND The prevalence of cardiac syndrome X (CSX) is considerable. Some patients show recurrent angina attacks and have a poor prognosis. However, the knowledge of CSX pathophysiological mechanism is still limited, and the treatment fails to achieve a satisfactory suppression of symptoms. Nicorandil has a beneficial effect on improving coronary microvascular dysfunction (CMD). This study aims to evaluate the clinical effects and safety of nicorandil on CSX patients. METHODS The Cochrane Library, Pubmed, EMBASE, ClinicalTrials.gov and 4 Chinese databases were searched to identify relevant studies. The Cochrane "Risk of bias" tool was used to assess the methodological quality of eligible studies. Meta-analysis was performed by RevMan 5.3 software. The Eggers test and meta-regression were performed by software Stata 14.0. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS Twenty four randomized controlled trials (RCTs) involving 2323 patients were included. Most of the included studies were classified as having an unclear risk of bias because of poor reported methodology. The main outcomes are angina symptoms improvement, resting electrocardiogram (ECG) improvement, treadmill test result, and endothelial function. Meta-analysis showed that nicorandil had some benefit on improving angina symptoms (RR 1.24, 95% CI 1.19 to 1.29, I = 20%, P < .00001), resting ECG (RR = 1.24, 95% IC: 1.15 to 1.33, I = 0%, P < .00001), and prolonged the time to 1 mm ST-segment depression in treadmill test result (WMD = 38.41, 95% IC: 18.46 to 58.36, I = 0%, P = .0002). Besides nicorandil could reduce the level of endothelin-1 (ET-1) (SMD = -2.22, 95% IC: -2.61 to -1.83, I = 77%, P < .00001) and increase the level of nitric oxide (NO) (WMD = 27.45, 95% IC: 125.65 to 29.24, I = 81%, P < .00001). No serious adverse drug event was reported. The Eggers test showed that significant statistical publication bias was detected (Eggers test P = .000). The quality of evidence ranged from very low to low. CONCLUSIONS Nicorandil shows the potential of improving angina symptoms, ECG, and endothelial dysfunction in patients with CSX. However, there is insufficient evidence for the clinical benefits of nicorandil due to the very low-quality evidence.
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The Efficacy and Safety of Nicorandil for Periprocedural Myocardial Injury in Patients Undergoing PCI: A Meta-Analysis.
Lu, Y, Hu, W, Song, Q, Wang, Q
Journal of interventional cardiology. 2020;:3293587
Abstract
PURPOSE To evaluate the efficacy and safety of nicorandil for periprocedural myocardial injury in patients undergoing PCI through meta-analysis of randomized controlled trials. METHODS We analyzed the clinical data of patients including the incidence of periprocedural myocardial injury (PMI) and major adverse cardiovascular events (MACE) from selected articles. RCTs were retrieved from medical literature databases. RR and 95% confidence intervals (CI) were calculated to compare the endpoints. RESULTS In total, 15 articles (16 trial comparisons) were retrieved which contained 2221 patients. In general, 1130 patients (50.9%) were randomized to the experimental group, whereas 1091 patients (49.1%) were randomized to the control group. The result showed that nicorandil significantly reduced the incidence of PMI and MACE after PCI compared to the control group. CONCLUSIONS Overall, early use of nicorandil in patients undergoing percutaneous coronary intervention (PCI) was associated with a significant reduction of PMI and MACE.
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Effects of Intracoronary Nicorandil on Myocardial Microcirculation and Clinical Outcomes in Patients with Acute Myocardial Infarction: A Meta-Analysis of Randomized Controlled Trials.
Shi, L, Chen, L, Qi, G, Tian, W, Zhao, S
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2020;(2):191-198
Abstract
BACKGROUND The amelioration of myocardial reperfusion in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PPCI) remains a significant issue. OBJECTIVE We conducted a meta-analysis of randomized controlled trials (RCTs) to better assess the effects of intracoronary nicorandil administration on myocardial microcirculation and clinical outcomes in these patients. METHODS The meta-analysis was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. A literature search was performed in the PubMed, Embase, Cochrane Library, and Web of Science databases up to April 2019, with no time or language limitations. Pooled risk ratios (RRs) were calculated to evaluate the treatment effects. RESULTS Seven RCTs involving a total of 562 patients were included. Compared with control, intracoronary nicorandil significantly reduced the incidence of thrombolysis in myocardial infarction (TIMI) grade ≤ 2 (RR 0.349; 95% confidence interval [CI] 0.199-0.611; P < 0.001) and TIMI myocardial perfusion grade ≤ 2 (RR 0.611; 95% CI 0.438-0.852; P = 0.004) and was associated with higher complete ST-segment resolution rates (RR 1.326; 95% CI 1.090-1.614; P = 0.005). However, no significant benefits were observed on clinical outcomes, including death (RR 0.370; 95% CI 0.085-1.618; P = 0.187), recurrent myocardial infarction (RR 0.507; 95% CI 0.156-1.655; P = 0.261), heart failure (RR 0.528; 95% CI 0.224-1.247; P = 0.145), and target lesion/vessel revascularization (RR 1.109; 95% CI 0.553-2.224; P = 0.770). CONCLUSIONS Intracoronary nicorandil can significantly improve myocardial microcirculation in patients with AMI undergoing PPCI, but it failed to offer clinically significant benefits.
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Effects of mitochondrial ATP-sensitive potassium channel activation (nicorandil) in patients with angina pectoris undergoing elective percutaneous coronary interventions: A meta-analysis of randomized controlled trials.
Zhu, H, Xu, X, Fang, X, Zheng, J, Chen, T, Huang, J
Medicine. 2019;(3):e14165
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AIMS: Nicorandil, which is a mitochondrial ATP-sensitive potassium channel opener, is believed to improve perioperative myocardial injury (PMI) in patients undergoing percutaneous coronary intervention (PCI), but recent studies have shown that nicorandil treatment did not improve functional and clinical outcomes in patients with angina pectoris who underwent elective PCI. We performed a meta-analysis to investigate the protective effect of nicorandil on perioperative injury in patients with angina pectoris who underwent elective PCI. METHODS The Medline, EMBASE, and Cochrane databases were searched for randomized clinical trials examining the effects of nicorandil. Two investigators independently selected suitable trials, extracted data, and assessed trial quality. RESULTS Seven studies of patients undergoing elective PCI, comprising a total of 979 patients, were included in this review. The results showed that nicorandil did not reduce the levels of markers of myocardial injury (standardized mean difference [SMD] 0.31 [95%CI -0.6, 1.22] for creatine kinase-MB [CK-MB] and 1.29 [95%CI -2.18, 4.76] for troponin I [TNI]), perioperative complications (relative risk [RR] 0.91 [95%CI 0.46-1.81]), target vessel revascularization (RR 0.79 [95%CI 0.50-1.25]) or major adverse cardiac events (MACE) (RR 0.83 [95%CI 0.49-1.43]). Nicorandil did reduce the corrected TIMI frame count (SMD-0.30 [95%CI -0.52, -0.09]). CONCLUSION Although nicorandil did not reduce the overall incidence of perioperative complications and the incidence of major adverse cardiac events (MACE) in patients with angina pectoris who underwent elective PCI, it could still improve no reflow and slow coronary flow.
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Effects of Nicorandil on All-Cause Mortality and Cardiac Events in CAD Patients Receiving PCI.
Zhang, X, Yu, Q, Yao, X, Liu, G, Li, J, Du, L
International heart journal. 2019;(4):886-898
Abstract
Current studies demonstrating the effects of nicorandil in the prognosis of coronary artery disease (CAD) patients who received percutaneous coronary intervention (PCI) are inconclusive due to the small sample size and small events rate.PubMed, OVID, CBM and CNKI databases were searched using a pre-specified search string to collect randomized controlled trials (RCTs) studying the effects of nicorandil on CAD patients receiving PCI. Data on all-cause mortality and cardiovascular events were collected. RevMan 5.3 software was used for meta-analysis. Subgroup analysis was conducted in patients receiving primary PCI (PPCI) and elective PCI (EPCI).A total of 18 RCTs were included in our final analysis. Nicorandil treatment significantly reduced total mortality in PPCI (Peto OR = 0.44, 95%CI 0.25-0.79, P = 0.006) and EPCI (Peto OR = 0.41, 95%CI 0.25-0.67, P = 0.0004), cardiovascular death in both PPCI (Peto OR = 0.41, 95%CI 0.20-0.84, P = 0.01) and EPCI (Peto OR = 0.40, 95%CI 0.20-0.80, P = 0.009), and heart failure in PPCI (RR = 0.36, 95%CI 0.22-0.59, P < 0.0001). When compared with placebo plus standard treatment or standard treatment alone, nicorandil plus standard treatment was associated with reduced total mortality in both PPCI and EPCI, CV death in EPCI, and heart failure in PPCI. Nicorandil is associated with lower risks of total mortality and CV death in PPCI and EPCI in those who received nicorandil > 28 days.Nicorandil as an adjunct therapy along with PCI is associated with reduced total mortality and cardiovascular death in PPCI and EPCI patients, and reduced heart failure in PPCI patients.
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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.
Xu, L, Wang, L, Li, K, Zhang, Z, Sun, H, Yang, X
Drug design, development and therapy. 2019;:1389-1400
Abstract
Background: Nicorandil prior to reperfusion by primary percutaneous coronary intervention (PCI) in patients with ST-segment elevated myocardial infarction (STEMI) has been suggested to be beneficial. However, results of previous randomized controlled trials (RCTs) were not consistent. We aimed to perform a meta-analysis to systematically evaluate the effect of periprocedural nicorandil in these patients. Methods: Related studies were obtained by searching PubMed, Embase and Cochrane's Library. Effects of perioperative nicorandil on the incidence of no-reflow phenomenon (NRP), corrected thrombolysis in myocardial infarction (TIMI) frame count (CTFC), wall motion score (WMS), left ventricular ejection fraction (LVEF), heart failure (HF) exacerbation of rehospitalization and incidence of major cardiovascular adverse events (MACE) were analyzed. Results: Eighteen RCTs with 2,055 patients were included. Treatment of nicorandil prior to PCI significantly reduced the incidence of NRP (risk ratio [RR]: 0.47, P<0.001), and reduced CTFC (weighed mean difference [WMD]: -4.54, P<0.001) immediately after PCI. Moreover, although nicorandil did not significantly affect WMS (WMD: 0.04, P=0.91), treatment of nicorandil significantly increased LVEF in STEMI patients undergoing primary PCI (WMD: 1.89%, P<0.001). In addition, nicorandil significantly reduced the risk of HF exacerbation or rehospitalization (RR: 0.44, P=0.001) and the incidence of MACE (RR: 0.68, P<0.001). Further analyses showed that effects of nicorandil on LVEF, HF exacerbation and MACE were consistent within one month after PCI and during follow-up. Conclusions: Periprocedural nicorandil improves coronary blood flow, cardiac systolic function and prognosis in STEMI patients receiving primary PCI.
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Effect of Nicorandil Administration on Preventing Contrast-Induced Nephropathy: A Meta-Analysis.
Zhan, B, Huang, X, Jiang, L, Bao, H, Cheng, X
Angiology. 2018;(7):568-573
Abstract
Several studies have investigated the effect of nicorandil on contrast-induced nephropathy (CIN) in patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI). However, the final results of these trials are not identical. This meta-analysis evaluated the role of nicorandil administration on CIN prevention. We searched databases to find randomized controlled trial (RCT) comparing nicorandil with hydration versus conventional hydration therapy on preventing CIN. Finally, 5 articles (805 patients) were included in our meta-analysis; the data showed that nicorandil was related to significant reduction in the risk of CIN (risk ratio = 0.37, 95% confidence interval [CI]: 0.22-0.61, P = .0001). We found not only the cystatin C level after operation was nonsignificant between 2 groups at the first 24 hours ( P = .65, 95% CI = -0.06 to 0.04) and 48 hours ( P = .19, 95% CI = -0.11 to 0.02) but also the serum creatinine level was nonsignificantly elevated, at 24 hours ( P = .46, 95% CI = -5.19 to 1.88) and 72 hours ( P = .49, 95% CI = -0.49 to 0.34). Our analysis suggested that the nicorandil treatment compared with conventional hydration can significantly reduce the risk of CIN.
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Nicorandil improves clinical outcomes in patients with stable angina pectoris requiring PCI: a systematic review and meta-analysis of 14 randomized trials.
Li, Y, Liu, H, Peng, W, Song, Z
Expert review of clinical pharmacology. 2018;(9):855-865
Abstract
Clinical trials concerning the effects of nicorandil in stable coronary artery disease (CAD) remain controversial. This study sought to evaluate the clinical outcomes of nicorandil following elective percutaneous coronary intervention (PCI). Areas covered: A meta-analysis including eligible randomized controlled trials (RCTs) with data on the nicorandil in stable CAD from Pubmed, EMBase, and Cochrane library (up to March 2018) was conducted. The primary end points were postprocedural incidence of myocardial infarction (MI) and contrast-induced nephropathy (CIN). The second end point was major adverse cerebrovascular and cardiovascular events (MACCE). Fourteen RCTs with a total of 1947 elective CAD patients were selected. Nicorandil significantly reduced the incidence of MI [n = 8; relative risk (RR) = 0.58; P = 0.001; I2 = 33.7%], and CIN (n = 5; RR = 0.36; P < 0.00001; I2 = 15.4%). However, There was no lowered risk of MACCE in nicorandil-treated patients [n = 10; odds RR = 0.75; P = 0.19; I2 = 0.0%]. Subsequent trial sequential analyses confirmed the effect of nicorandil on MI and CIN in PCI. Expert commentary: The present systematic review and meta-analysis suggests that nicorandil could improve clinical outcomes in terms of perioperative MI and CIN. However, the effect of nicorandil on the MACCE risk is not obvious. Future high-quality, large-scale clinical trials should majorly concern about the long-term clinical effect of nicorandil.
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Effect of nicorandil in patients with heart failure: a systematic review and meta-analysis.
Zhao, F, Chaugai, S, Chen, P, Wang, Y, Wang, DW
Cardiovascular therapeutics. 2014;(6):283-96
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BACKGROUND AND PURPOSE It is unclear whether nicorandil, a metabolic therapeutic drug, can be applied clinically to therapy of heart failure (HF). This meta-analysis evaluated therapeutic effects of nicorandil on HF patients. EXPERIMENTAL APPROACH We performed a systematic review and meta-analysis of published studies evaluating effect of nicorandil on HF patients. Studies were stratified according to controlled versus uncontrolled designs and analyzed using random-effects meta-analysis models. KEY RESULTS We identified a total of 20 studies with a total of 1222 patients. In five randomized controlled studies, nicorandil treatment resulted in reduction in all-cause mortality and hospitalization for cardiac causes (HR: 0.35, P < 0.001) and improved cardiac pump function (SMD: 0.31, P = 0.02). In 15 observational studies, nicorandil therapy increases cardiac pump function (SMD: 0.75, P < 0.001), improves NYHA functional class (WMD: -1.33, P < 0.001), decreases PCWP (WMD: -6.86 mm Hg, P < 0.001), and pulmonary arterial pressure (SMD: -0.84, P < 0.001). CONCLUSIONS AND IMPLICATIONS The use of nicorandil in HF patients exerts substantial beneficial effects, suggesting that it may be an additional therapeutic agent for HF.