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1.
Effectiveness and Safety of Intravenous Nicorandil Application in Patients With Acute Heart Failure With Low Baseline Blood Pressure.
Zhang, Y, Cai, Z, Ke, X, Qiu, W, Ke, S, Wu, Y
Heart, lung & circulation. 2022;(1):95-100
Abstract
AIM: To evaluate the effectiveness and safety of intravenous nicorandil application in patients with acute heart failure (AHF) with low baseline blood pressure (systolic blood pressure <110 mmHg). METHOD This prospective, controlled, single-centre study randomised 147 patients with AHF with low baseline blood pressure (including both emergent admission and newly developed low blood pressure while in hospital) to one of the following two groups: (1) control group (conventional diuretics, positive inotropic agents, and related therapy according to the guidelines); and (2) intervention group (intravenous [IV] nicorandil application plus routine care). Dyspnoea severity, the ratio of E to e' (E/e'), the incidence of side effects and adverse events, N-terminal pro-brain natriuretic peptide (NT-proBNP) level, left ventricular ejection fraction (LVEF; left ventricular systolic function) before discharge, average length of hospitalisation, LVEF and soluble suppression of tumorigenicity-2 (sST2) at 3 months after discharge, incidence of major adverse cardiac and cerebrovascular events (MACCE) and readmission rate within 3 months were recorded and compared between the two groups. RESULTS Compared to the control group, nicorandil relieved dyspnoea effectively and improved E/e' significantly; the level of NT-proBNP was lower, LVEF was higher before discharge, and average length of hospital stay was shorter in the intervention group. After 3 months, the LVEF was higher, sST2 was lower, and the readmission rate was lower in the intervention group; there was no statistically significant difference in MACCE. CONCLUSIONS Patients with AHF with low baseline blood pressure could benefit from IV nicorandil application in the urgent phase, but the long-term profits remained to be confirmed.
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Achieving Optimal Medical Therapy: Insights From the ORBITA Trial.
Foley, M, Rajkumar, CA, Shun-Shin, M, Ganesananthan, S, Seligman, H, Howard, J, Nowbar, AN, Keeble, TR, Davies, JR, Tang, KH, et al
Journal of the American Heart Association. 2021;(3):e017381
Abstract
Background In stable coronary artery disease, medications are used for 2 purposes: cardiovascular risk reduction and symptom improvement. In clinical trials and clinical practice, medication use is often not optimal. The ORBITA (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) trial was the first placebo-controlled trial of percutaneous coronary intervention. A key component of the ORBITA trial design was the inclusion of a medical optimization phase, aimed at ensuring that all patients were treated with guideline-directed truly optimal medical therapy. In this study, we report the medical therapy that was achieved. Methods and Results After enrollment into the ORBITA trial, all 200 patients entered a 6-week period of intensive medical therapy optimization, with initiation and uptitration of risk reduction and antianginal therapy. At the prerandomization stage, the median number of antianginals established was 3 (interquartile range, 2-4). A total of 195 patients (97.5%) reached the prespecified target of ≥2 antianginals; 136 (68.0%) did not stop any antianginals because of adverse effects, and the median number of antianginals stopped for adverse effects per patient was 0 (interquartile range, 0-1). Amlodipine and bisoprolol were well tolerated (stopped for adverse effects in 4/175 [2.3%] and 9/167 [5.4%], respectively). Ranolazine and ivabradine were also well tolerated (stopped for adverse effects in 1/20 [5.0%] and 1/18 [5.6%], respectively). Isosorbide mononitrate and nicorandil were stopped for adverse effects in 36 of 172 (20.9%) and 32 of 141 (22.7%) of patients, respectively. Statins were well tolerated and taken by 191 of 200 (95.5%) patients. Conclusions In the 12-week ORBITA trial period, medical therapy was successfully optimized and well tolerated, with few drug adverse effects leading to therapy cessation. Truly optimal medical therapy can be achieved in clinical trials, and translating this into longer-term clinical practice should be a focus of future study. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02062593.
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Myocardial protective effect of intracoronary administration of nicorandil and alprostadil via targeted perfusion microcatheter in patients undergoing elective percutaneous coronary intervention: A randomized controlled trial.
Zhang, W, Dai, J, Zheng, X, Xu, K, Yang, X, Shen, L, Wang, X, Hao, Z, Qiu, X, Jiang, L, et al
Medicine. 2021;(15):e25551
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Abstract
BACKGROUND The aim of the study was to evaluate the efficacy of nicorandil and alprostadil on myocardial protection in patients undergoing elective percutaneous coronary intervention (PCI). METHODS In this prospective, single-blinded, randomized controlled study, 90 consecutive patients scheduled for elective PCI for de novo coronary lesions were assigned to the nicorandil, alprostadil, and nitroglycerin groups in a 1:1:1 ratio. Drugs were administered intracoronary via a targeted perfusion microcatheter. The primary endpoint was the thrombolysis in myocardial infarction (TIMI) myocardial perfusion frame count (TMPFC). Additionally, the corrected TIMI frame count (cTFC), TIMI myocardial perfusion grade (TMPG), and incidence of periprocedural myocardial injury (PMI) were assessed. RESULTS Both nicorandil and alprostadil were significantly effective in reducing TMPFC (114.6 ± 33.7 vs 93.4 ± 30.9, P = .016; 114.3 ± 34.3 vs 94.7 ± 33.3, P = .029, respectively). Similar findings were observed in the improvement of cTFC (20.3 ± 10.5 vs 13.5 ± 5.0, P = .003; 20.2 ± 7.4 vs 15.2 ± 5.2, P = .003, respectively) and percentage of TMPG 3 (100% vs 82.8%, P = .052; 83.3% vs 96.7%, P = .196, respectively); whereas, nitroglycerin produced a limited effect on TMPFC (114.4 ± 30.9 vs 112.1 ± 31.9, P = .739), cTFC (19.4 ± 7.2 vs 19.3 ± 7.2, P = .936), and percentage of TMPG 3 (86.7% vs 86.7%, P = 1.000). No significant difference was found in the incidence of PMI (16.7% vs 16.0% vs 27.6%, P = .537), though it was comparatively lower in the nicorandil and alprostadil groups. Furthermore, the intracoronary administration of nicorandil and alprostadil had a mild effect on blood pressure and heart rate. CONCLUSIONS The intracoronary administration of nicorandil and alprostadil via a targeted perfusion microcatheter was more effective in improving myocardial perfusion in patients undergoing elective PCI than nitroglycerin.
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Standard vs. double dose of intravenous nicorandil in preventing contrast-induced nephropathy in patients with coronary heart disease undergoing elective coronary procedures.
Zeng, Z, Zhang, H, Zhang, P, Li, Y, Fu, N
Coronary artery disease. 2021;(3):256-257
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Efficacy of nicorandil on the prevention of contrast-induced nephropathy in patients with coronary heart disease undergoing percutaneous coronary intervention.
Zhang, X, Yang, S, Zhang, P, Fu, N
Coronary artery disease. 2020;(3):284-288
Abstract
OBJECTIVES The purpose of this study was to explore the effect of nicorandil on the incidence of contrast-induced nephropathy in patients with coronary heart disease undergoing percutaneous coronary intervention. METHODS This study randomized 300 patients undergoing percutaneous coronary intervention to receive conventional treatment in the control group (hydration only; n = 150) vs. nicorandil therapy (nicorandil 10 mg three times daily plus hydration; n = 150). The primary endpoint was the incidence of contrast-induced nephropathy, defined as rise in serum creatinine ≥44.2 μmol/L or >25% above baseline within 72 hours after exposure to contrast administered during percutaneous coronary intervention. Secondary endpoints included differences in post-percutaneous coronary intervention serum creatinine, blood urea nitrogen, creatinine clearance rate, cystatin-C, and occurrence of major adverse events. RESULTS Contrast-induced nephropathy incidence was 3.3% (5/150) in the nicorandil group vs. 10.7% (16/150) in the control group (P < 0.05). At 48 and 72 hours after contrast administration, cystatin-C levels were significantly lower and creatinine clearance rate were significantly higher with nicroandil therapy compared to conventional treatment (all P values <0.05). No statistical difference was observed in the incidence of major post-procedure side effect events in hospital and fourteen days of follow-up period between the nicorandil group and control group (3.3% vs. 4.0%, P > 0.05). CONCLUSION Compared to conventional treatment, oral nicorandil therapy was associated with less contrast-induced nephropathy and improved renal function following contrast administration during percutaneous coronary intervention.
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Preventive Effects of Nicorandil Against Contrast-Induced Nephropathy in Patients With Moderate Renal Insufficiency Undergoing Percutaneous Coronary Intervention.
Zhang, P, Li, WY, Yang, SC, Fu, NK, Liu, XG, Zhang, X, Cong, HL, Lin, WH, Tian, FS, Lu, CZ, et al
Angiology. 2020;(2):183-188
Abstract
We investigated the preventive effect of nicorandil on contrast-induced nephropathy (CIN) in patients with moderate renal insufficiency undergoing percutaneous coronary intervention (PCI). A total of 250 patients with a creatinine clearance (crCl) ≤60 mL/min undergoing PCI were randomly assigned to either a nicorandil group (nicorandil 10 mg 3 times/d and hydration; n = 125) or a control group (hydration only; n = 125). The first end point was the incidence of CIN defined as an increase in serum creatinine (Scr) levels by ≥0.5 mg/dL or ≥25% within 72 hours after exposure to the contrast medium. The secondary end points were (1) changes in Scr, blood urea nitrogen, and crCl and (2) the incidence of major adverse events during hospitalization. The incidence of CIN was 1.6% (2/125) in the nicorandil group and 9.6% (12/125) in the control group (P = .011). There was no obvious difference in the incidence of major adverse events during hospitalization between the nicorandil and the control group (4.0% vs 4.8%, P = 1.000). Multivariate logistic regression analysis showed that nicorandil was a protective factor for CIN (odds ratios = 0.126, 95% confidence interval: -19.996 to -0.932, P = .012). Prophylactic administration of nicorandil may prevent against CIN in patients with moderate renal insufficiency undergoing PCI.
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Comparison of double-dose vs. usual dose of nicorandil for the prevention of contrast-induced nephropathy after cardiac catheterization.
Zeng, Z, Fu, X, Zhang, X, Fu, N
International urology and nephrology. 2019;(11):1999-2004
Abstract
PURPOSE Contrast-associated nephropathy (CIN), the third main reason of the acute kidney injury (AKI) in inpatients, is a potentially severe side effect of angiography and the preventive role of nicorandil on CIN is still controversal. The aim of this clinical trial was to evaluate the preventive role of different doses of nicorandil on CIN in patients experiencing cardiac catheterization compared with hydration. METHODS We recorded outcomes from 330 patients who were randomly divided to either a double-dose (30 mg/day) nicorandil group or to a usual-dose (15 mg/day) nicorandil group or a control group (hydration only). The primary endpoint of the current research was the occurrence of CIN, which is defined as a relative elevation of SCr level of 25% above the baseline or an absolute increment of SCr of more than 44.2 µmol/L (0.5 mg/dL) within 48 or 72 h after contrast medium exposure. Additional endpoints were the changes in BUN, SCr, Cys-C, eGFR, and CRP level within 48 h after contrast agent exposure and major adverse events occurring during hospitalization and 14 days of follow-up. RESULTS 6 out of 111 patients (5.4%) had contrast-induced nephropathy in the double-dose group and it occured 11 out of 107 patients (10.3%) in the usual-dose group, 16 out of 112 patients (14.3%) in the control group. There was a significant difference in the occurrence of CIN between the double-dose group and the control group at 48 h after taking the radiocontrast medium (p = 0.026) while no such significant difference observed in the usual-dose group and the control group (p = 0.367), the double-dose group and usual-dose group (p = 0.180) as well. CONCLUSIONS Daily peri-procedural usual-dose nicorandil could just relieve contrast-induced renal injury, only double-dose nicorandil was associated with a reduced incidence of CI-AKI compared with hydration.
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Effects of Nicorandil Versus Nitroglycerin on Arterial Oxygenation During Two-Lung Ventilation and One-Lung Ventilation in Patients With Risk Factors for Myocardial Ischemia: A Prospective, Randomized, Double-Blind Study.
Murakami, C, Kawano, H, Kinoshita, M, Kondo, A, Inoue, M
Journal of cardiothoracic and vascular anesthesia. 2019;(3):702-709
Abstract
OBJECTIVES To compare the effects of nicorandil and nitroglycerin on arterial oxygenation during two-lung ventilation (TLV) and one-lung ventilation (OLV) in patients with risk factors for myocardial ischemia. DESIGN A prospective, randomized, double-blind study. SETTING A tertiary care hospital. PARTICIPANTS Fifty-six patients scheduled for elective video-assisted thoracic surgery were assigned randomly to either the nicorandil group or the nitroglycerin group. INTERVENTIONS Patients in the nicorandil group received a bolus dose of nicorandil, 0.08 mg/kg during induction of anesthesia, followed by a continuous infusion at a rate of 0.08 mg/kg/h. Patients in the nitroglycerin group received a continuous infusion of nitroglycerin at a rate of 1 µg/kg/min from the induction of anesthesia. MEASUREMENTS AND MAIN RESULTS Arterial blood gas analysis was performed at the following points: before induction of anesthesia; during TLV; at 5, 10, 20, and 30 minutes after the initiation of OLV. PaO2 at TLV (479.7 ± 57.1 v 408.2 ± 70.9 mmHg, p < 0.001); and at 5 minutes (344.8 ± 85.1 v 282.6 ± 85.8 mmHg, p = 0.012), 20 minutes (215.7 ± 103.0 v 158.2 ± 74.5 mmHg, p = 0.027), and 30 minutes (198.8 ± 103.5 v 147.5 ± 64.1 mmHg, p = 0.039) after OLV was significantly higher in the nicorandil group than in the nitroglycerin group. CONCLUSION This study demonstrated that oxygenation during TLV and OLV was significantly higher in patients receiving nicorandil than in those receiving nitroglycerin.
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Effects of Early Intracoronary Administration of Nicorandil During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction.
Feng, C, Liu, Y, Wang, L, Niu, D, Han, B
Heart, lung & circulation. 2019;(6):858-865
Abstract
BACKGROUND 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. METHODS This randomised controlled trial involved 170 STEMI patients who underwent PCI. All patients underwent thrombectomy and tirofiban injection (10μg/kg) distal to the vascular lesion via a suction catheter, followed by nicorandil (84 patients; 2mg) or saline injection (86 patients; 2mL) at the same site. The primary endpoint (major adverse cardiac events, MACEs) was 6-month cardiovascular mortality or unplanned readmission rate due to worsening congestive heart failure. The secondary endpoints were thrombolysis in myocardial infarction (TIMI) grade, TIMI myocardial perfusion grade (TMPG), resolution of ST-segment elevation (defined as >50% decrease in ST elevation); and ventricular arrhythmias. RESULTS Upon Kaplan-Meier analysis, freedom from MACEs was 92.9% in the nicorandil group and 81.4% in the placebo (p=0.026). The numbers of patients achieving TIMI grade 3 (95.24% vs. 86.05%; p=0.040) and TMPG 3 (94.05% vs. 83.72%; p=0.033) were greater in the nicorandil group than in the control group. Resolution of ST-segment elevation occurred in 84.52% and 68.60% patients in the nicorandil and control groups, respectively (p=0.014). Ventricular arrhythmias occurred in 5.95% and 16.28% patients in the nicorandil and control groups, respectively (p=0.032). CONCLUSIONS Early administration of nicorandil distal to the vascular lesion during PCI in STEMI patients may reduce the incidence of reperfusion injury, and improve short-term clinical outcomes. TRIAL REGISTRATION NUMBER NCT02435797.
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Efficacy and safety of nicorandil on perioperative myocardial injury in patients undergoing elective percutaneous coronary intervention: results of the PENMIPCI trial.
Ye, Z, Lu, H, Su, Q, Long, M, Li, L
Drug design, development and therapy. 2018;:2591-2599
Abstract
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.