{"title":"初次经皮冠状动脉介入治疗前口服尼可地尔对无血流循环的影响：一项随机对照试验。","authors":"Tarek Abdel-Hameed Nagib Ahmed, Shimaa Sayed Khidr, Ahmed Abdelnaser Abdelrady, Salwa Roshdy Demitry, Heba Mahmoud El-Naggar","doi":"10.1007/s00392-025-02734-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Prior studies and meta-analyses showed cardioprotective benefits of intravenous or intracoronary nicorandil administration in ST-segment elevation myocardial infarction (STEMI). However, little is known about the efficacy of oral nicorandil in this context, especially that parenteral forms are not widely available.</p><p><strong>Aim: </strong>To investigate the impact of oral nicorandil administered before primary percutaneous coronary intervention (PPCI) on no-reflow and to assess the in-hospital and 3-month major adverse cardiac events (MACE).</p><p><strong>Methods: </strong>A total of 302 patients with STEMI undergoing PPCI were randomly assigned in a 1:1 fashion to the Nicorandil-group, who received pre-PPCI oral nicorandil 20 mg followed by maintenance 20 mg b.i.d. for 3 months, and the Control-group. The primary endpoint was no-reflow defined as TIMI flow ≤ 2. Secondary endpoints included myocardial blush grade (MBG), ST-segment resolution, electrocardiographic repolarization dispersion, and in-hospital and 3-month MACE. Baseline and follow-up echocardiography were performed. A 3-month cardiac magnetic resonance (CMR) was performed in a subset of 50 patients.</p><p><strong>Results: </strong>Nicorandil-group showed significantly lower rates of no-reflow (11.9% vs 24.5%, p = 0.005), better MBG, higher rates of complete ST-resolution, and better indices of repolarization dispersion compared to the Control-group. Pre-PPCI nicorandil was among the independent protectors against no-reflow (OR = 0.43, 95%CI = 0.23-0.81, p = 0.01). The Nicorandil-group demonstrated significantly better LV function and lower MACE at follow-up. Three-month CMR data showed microvascular obstruction in two patients among the Control-group and none among the Nicorandil-group (p = 0.14).</p><p><strong>Conclusion: </strong>Oral nicorandil was associated with post-PPCI lower rates of no-reflow and improved myocardial reperfusion. Moreover, it showed improved LVEF and reduced MACE at 3 months.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of oral nicorandil administration prior to primary percutaneous coronary intervention on no-reflow: a randomized controlled trial.\",\"authors\":\"Tarek Abdel-Hameed Nagib Ahmed, Shimaa Sayed Khidr, Ahmed Abdelnaser Abdelrady, Salwa Roshdy Demitry, Heba Mahmoud El-Naggar\",\"doi\":\"10.1007/s00392-025-02734-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Prior studies and meta-analyses showed cardioprotective benefits of intravenous or intracoronary nicorandil administration in ST-segment elevation myocardial infarction (STEMI). However, little is known about the efficacy of oral nicorandil in this context, especially that parenteral forms are not widely available.</p><p><strong>Aim: </strong>To investigate the impact of oral nicorandil administered before primary percutaneous coronary intervention (PPCI) on no-reflow and to assess the in-hospital and 3-month major adverse cardiac events (MACE).</p><p><strong>Methods: </strong>A total of 302 patients with STEMI undergoing PPCI were randomly assigned in a 1:1 fashion to the Nicorandil-group, who received pre-PPCI oral nicorandil 20 mg followed by maintenance 20 mg b.i.d. for 3 months, and the Control-group. The primary endpoint was no-reflow defined as TIMI flow ≤ 2. Secondary endpoints included myocardial blush grade (MBG), ST-segment resolution, electrocardiographic repolarization dispersion, and in-hospital and 3-month MACE. Baseline and follow-up echocardiography were performed. A 3-month cardiac magnetic resonance (CMR) was performed in a subset of 50 patients.</p><p><strong>Results: </strong>Nicorandil-group showed significantly lower rates of no-reflow (11.9% vs 24.5%, p = 0.005), better MBG, higher rates of complete ST-resolution, and better indices of repolarization dispersion compared to the Control-group. Pre-PPCI nicorandil was among the independent protectors against no-reflow (OR = 0.43, 95%CI = 0.23-0.81, p = 0.01). The Nicorandil-group demonstrated significantly better LV function and lower MACE at follow-up. Three-month CMR data showed microvascular obstruction in two patients among the Control-group and none among the Nicorandil-group (p = 0.14).</p><p><strong>Conclusion: </strong>Oral nicorandil was associated with post-PPCI lower rates of no-reflow and improved myocardial reperfusion. Moreover, it showed improved LVEF and reduced MACE at 3 months.</p>\",\"PeriodicalId\":10474,\"journal\":{\"name\":\"Clinical Research in Cardiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-08-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research in Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00392-025-02734-0\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research in Cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00392-025-02734-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：先前的研究和荟萃分析显示，在st段抬高型心肌梗死（STEMI）中静脉或冠状动脉内给予尼可地尔对心脏有保护作用。然而，在这种情况下，口服尼可地尔的疗效知之甚少，特别是肠外形式尚未广泛使用。目的：探讨首次经皮冠状动脉介入治疗（PPCI）前口服尼可地尔对无血流流的影响，并评估住院和3个月主要心脏不良事件（MACE）。方法：将302例行PPCI的STEMI患者按1:1的比例随机分为尼可地尔组和对照组。尼可地尔组在PPCI前口服尼可地尔20 mg，维持20 mg，每日1次，持续3个月。主要终点为无回流，定义为TIMI流量≤2。次要终点包括心肌红晕等级（MBG）、st段分辨率、心电图复极离散度、住院和3个月MACE。进行基线和随访超声心动图检查。对50例患者进行了为期3个月的心脏磁共振（CMR）检查。结果：与对照组相比，尼可地尔组无回流率显著降低（11.9% vs 24.5%, p = 0.005）， MBG更好，st段完全分辨率更高，复极化弥散指数更好。ppci前尼可地尔是预防无回流的独立保护剂之一（OR = 0.43, 95%CI = 0.23-0.81, p = 0.01）。尼可地尔组在随访中表现出较好的左室功能和较低的MACE。三个月CMR数据显示，对照组中有2例患者出现微血管阻塞，尼可地尔组无一例（p = 0.14）。结论：口服尼可地尔与ppci后较低的无回流率和改善的心肌再灌注有关。3个月时LVEF改善，MACE降低。
Impact of oral nicorandil administration prior to primary percutaneous coronary intervention on no-reflow: a randomized controlled trial.
Background: Prior studies and meta-analyses showed cardioprotective benefits of intravenous or intracoronary nicorandil administration in ST-segment elevation myocardial infarction (STEMI). However, little is known about the efficacy of oral nicorandil in this context, especially that parenteral forms are not widely available.
Aim: To investigate the impact of oral nicorandil administered before primary percutaneous coronary intervention (PPCI) on no-reflow and to assess the in-hospital and 3-month major adverse cardiac events (MACE).
Methods: A total of 302 patients with STEMI undergoing PPCI were randomly assigned in a 1:1 fashion to the Nicorandil-group, who received pre-PPCI oral nicorandil 20 mg followed by maintenance 20 mg b.i.d. for 3 months, and the Control-group. The primary endpoint was no-reflow defined as TIMI flow ≤ 2. Secondary endpoints included myocardial blush grade (MBG), ST-segment resolution, electrocardiographic repolarization dispersion, and in-hospital and 3-month MACE. Baseline and follow-up echocardiography were performed. A 3-month cardiac magnetic resonance (CMR) was performed in a subset of 50 patients.
Results: Nicorandil-group showed significantly lower rates of no-reflow (11.9% vs 24.5%, p = 0.005), better MBG, higher rates of complete ST-resolution, and better indices of repolarization dispersion compared to the Control-group. Pre-PPCI nicorandil was among the independent protectors against no-reflow (OR = 0.43, 95%CI = 0.23-0.81, p = 0.01). The Nicorandil-group demonstrated significantly better LV function and lower MACE at follow-up. Three-month CMR data showed microvascular obstruction in two patients among the Control-group and none among the Nicorandil-group (p = 0.14).
Conclusion: Oral nicorandil was associated with post-PPCI lower rates of no-reflow and improved myocardial reperfusion. Moreover, it showed improved LVEF and reduced MACE at 3 months.
期刊介绍：
Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery.
As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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