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随机对照试验研究远程缺血预处理在 ST 段抬高型心肌梗死患者经皮冠状动脉介入治疗中的辅助作用(RIC-STEMI)。

Randomized controlled trial of remote ischaemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI).

机构信息

Department of Cardiology, Hospital de Braga, Braga, Portugal.

Department of Surgery and Physiology, Cardiovascular R&D Unit, Faculty of Medicine, University of Porto, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal.

出版信息

Basic Res Cardiol. 2018 Mar 7;113(3):14. doi: 10.1007/s00395-018-0672-3.

DOI:10.1007/s00395-018-0672-3
PMID:29516192
Abstract

To test whether remote ischaemic conditioning (RIC) as adjuvant to standard of care (SOC) would prevent progression towards heart failure (HF) after ST-elevation myocardial infarction (STEMI). Single-centre parallel 1:1 randomized trial (computerized block-randomization, concealed allocation) to assess superiority of RIC (3 cycles of intermittent 5 min lower limb ischaemia) over SOC in consecutive STEMI patients (NCT02313961, clinical trials.gov). From 258 patients randomized to RIC or SOC, 9 and 4% were excluded because of unconfirmed diagnosis and previously unrecognized exclusion criteria, respectively. Combined primary outcome of cardiac mortality and hospitalization for HF was reduced in RIC compared with SOC (n = 231 and 217, respectively; HR = 0.35, 95% CI 0.15-0.78) as well as each outcome in isolation. No difference was found in serum troponin I levels between groups. Median and maximum follow-up time were 2.1 and 3.7 years, respectively. In-hospital HF (RR = 0.68, 95% CI 0.47-0.98), need for diuretics (RR = 0.68, 95% CI 0.48-0.97) and inotropes and/or intra-aortic balloon pump (RR = 0.17, 95% CI 0.04-0.76) were decreased in RIC. On planned 12 months follow-up echocardiography (n = 193 and 173 in RIC and SOC, respectively) ejection fraction (EF) recovery was enhanced in patients presenting with impaired left ventricular (LV) function (10% absolute difference in median EF compared with SOC; P < 0.001). In addition to previously reported improved myocardial salvage index and reduced infarct size RIC was shown beneficial in a combined hard clinical endpoint of cardiac mortality and hospitalization for HF. Improved EF recovery was also documented in patients with impaired LV function.

摘要

目的

检验辅助标准治疗(SOC)的远程缺血预处理(RIC)是否可预防 ST 段抬高型心肌梗死(STEMI)后心力衰竭(HF)的进展。

方法

单中心平行 1:1 随机试验(计算机分组,隐藏分组),评估连续 STEMI 患者中 RIC(3 个周期间歇性 5 分钟下肢缺血)与 SOC 的优势(NCT02313961,clinicaltrials.gov)。258 例随机分配至 RIC 或 SOC 的患者中,分别有 9%和 4%因诊断不明确和未识别的排除标准而被排除。与 SOC 相比,RIC 组的心脏死亡率和 HF 住院联合主要结局(n=231 和 217,HR=0.35,95%CI 0.15-0.78)以及各单独结局均降低。两组间血清肌钙蛋白 I 水平无差异。中位和最大随访时间分别为 2.1 年和 3.7 年。住院期间 HF(RR=0.68,95%CI 0.47-0.98)、利尿剂(RR=0.68,95%CI 0.48-0.97)、正性肌力药和/或主动脉内球囊泵(RR=0.17,95%CI 0.04-0.76)的使用率在 RIC 组降低。计划于 12 个月时行超声心动图随访(RIC 和 SOC 组分别为 n=193 和 173),左心室(LV)功能受损患者的射血分数(EF)恢复增强(与 SOC 相比,EF 中位数绝对差值为 10%;P<0.001)。除了之前报道的心肌挽救指数改善和梗死面积减少外,RIC 对心脏死亡率和 HF 住院的联合硬终点也有益。LV 功能受损患者的 EF 恢复也得到改善。

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