Miyoshi Toru, Ejiri Kentaro, Kohno Kunihisa, Nakahama Makoto, Doi Masayuki, Munemasa Mitsuru, Murakami Masaaki, Takaishi Atsushi, Kawai Yusuke, Sato Tetsuya, Sato Katsumasa, Oka Takefumi, Takahashi Natsuki, Sakuragi Satoru, Mima Atsushi, Enko Kenki, Hosogi Shingo, Nanba Seiji, Hirami Ryoichi, Nakamura Kazufumi, Ito Hiroshi
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan.
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan.
Int J Cardiol. 2017 Jun 1;236:36-42. doi: 10.1016/j.ijcard.2017.02.028. Epub 2017 Feb 10.
The effect of remote ischemic preconditioning (RIPC) and nicorandil on periprocedural myocardial injury (pMI) in patients with planned percutaneous coronary intervention (PCI) remains controversial. The aim of this randomized trial was to evaluate the effect of RIPC or nicorandil on pMI following PCI in patients with stable coronary artery disease (CAD) compared with a control group.
Patients with stable CAD who planned to undergo PCI were assigned to a 1:1:1 ratio to control, RIPC, or intravenous nicorandil (6mg/h). Automated RIPC was performed by a device, which performs intermittent arm ischemia through three cycles of 5min of inflation and 5min of deflation of a pressure cuff. The primary outcome was the incidence of pMI, determined by an elevation in high-sensitive troponin T or creatine kinase myocardial band at 12 or 24h after PCI. The secondary outcomes were ischemic events during PCI and adverse clinical events at 8months after PCI.
A total of 391 patients were enrolled. The incidence of pMI following PCI was not significantly different between the control group (48.9%) and RIPC group (39.5%; p=0.14), or between the control group and nicorandil group (40.3%; p=0.17). There were no significant differences in ischemic events during PCI or adverse clinical events within 8months after PCI among the three groups.
This study demonstrated moderate reductions in biomarker release and pMI by RIPC or intravenous nicorandil prior to the PCI consistently, but may have failed to achieve statistical significance because the study was underpowered.
对于计划接受经皮冠状动脉介入治疗（PCI）的患者，远程缺血预处理（RIPC）和尼可地尔对围手术期心肌损伤（pMI）的影响仍存在争议。本随机试验的目的是评估与对照组相比，RIPC或尼可地尔对稳定型冠状动脉疾病（CAD）患者PCI术后pMI的影响。
计划接受PCI的稳定型CAD患者按1:1:1的比例分为对照组、RIPC组或静脉注射尼可地尔组（6mg/h）。RIPC由一种设备自动执行，该设备通过压力袖带充气5分钟和放气5分钟的三个循环来进行间歇性手臂缺血。主要结局是pMI的发生率，通过PCI术后12或24小时高敏肌钙蛋白T或肌酸激酶心肌同工酶的升高来确定。次要结局是PCI期间的缺血事件和PCI术后8个月的不良临床事件。
共纳入391例患者。对照组（48.9%）和RIPC组（39.5%；p=0.14）之间，以及对照组和尼可地尔组（40.3%；p=0.17）之间，PCI术后pMI的发生率无显著差异。三组之间在PCI期间的缺血事件或PCI术后8个月内的不良临床事件方面无显著差异。
本研究表明，在PCI之前，RIPC或静脉注射尼可地尔可使生物标志物释放和pMI适度降低，但可能由于研究效能不足而未能达到统计学显著性。
