Effect of Remote Ischemic Preconditioning on Myocardial Injury in Noncardiac Surgery: the PRINCE Randomized Clinical Trial.

IF 35.5 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Circulation Pub Date : 2025-06-13 DOI:10.1161/CIRCULATIONAHA.125.075254

Massimiliano Greco, Gaetano Lombardi, Claudia Brusasco, Marina Pieri, Agostino Roasio, Fabrizio Monaco, Levan Berikashvili, Alessandro Belletti, Francesco Meroi, Stefano Fresilli, Aituar Kabibulatov, Giuseppe Giardina, Andrea Russo, Federico Mattia Oliva, Sergey Efremov, Rosalba Lembo, Lini Wang, Simone Vietri, Elena Momesso, Filippo D'Amico, Kristina Kadantseva, Rosa Labanca, Pavel Ryzhkov, Marilena Marmiere, Valery Subbotin, Alessandro Pruna, Nerlep Rana, Francesca Livi, Hugo Mantilla-Gutierrez, Fabio Guarracino, Lorenzo Schiavoni, Ivan Šitum, Marco Micali, Stefano Bosso, Anastasia Smirnova, Giuseppe Fresta, Andrey Cherednichenko, Luigi Beretta, Giacomo Monti, Lian Kah Ti, Pasquale Sansone, Francesco Corradi, Maurizio Cecconi, Andrey Yavorovskiy, Chong Lei, Aidos Konkayev, Tiziana Bove, Valery Likhvantsev, Alberto Zangrillo, Giovanni Landoni, Rinaldo Bellomo, Remo Daniel Covello, Stefano Turi

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引用次数: 0

Abstract

Background: Major noncardiac surgery carries high rates of postoperative myocardial injury and other complications. Remote ischemic preconditioning (RIPC) was reported to decrease these complications. However, such supportive evidence lacks robustness.

Methods: In a multinational, double-blind trial, we randomly assigned adult high-risk patients undergoing noncardiac surgical procedures to receive RIPC or sham-RIPC after the induction of general anesthesia and before surgery. RIPC involved three 5-minute ischemic cycles, each followed by 5 minutes of reperfusion, using a blood-pressure cuff inflated to 200 mmHg. The primary endpoint was the rate of myocardial injury defined by an increase in postoperative troponin levels above the highest 99th percentile of reference values. Secondary outcomes included myocardial infarction, stroke, acute kidney injury, need for intensive care unit, length of hospital stay and 30-day all-cause mortality.

Results: We recruited 1213 patients in 25 hospitals and 8 countries. We randomly assigned 599 to RIPC and 614 to sham-RIPC. The most frequent surgical procedures were abdominal and intrathoracic surgeries (406 patients, 33.6%). RIPC was applied to the upper limb in 1,014 patients (84.8%) and to the lower limb in 182 patients (15.2%). Postoperative myocardial injury occurred in 215/566 patients (38.0%) in the RIPC group and in 223/596 patients (37.4%) in the sham-RIPC group (relative risk, 1.02; 95% confidence interval, 0.88 to 1.18; P=0.84). There were no significant differences in the rate of any secondary outcomes. We observed eleven episodes of limb petechiae (10 [1.7%] in the RIPC group vs 1 [0.2%] in the sham-RIPC group) and 34 (6.0%) hospital readmissions in the RIPC group vs 20 (3.5%) in the sham-RIPC group.

Conclusions: Among adult patients undergoing noncardiac surgery, RIPC did not reduce myocardial injury or other postoperative complications.

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远程缺血预处理对非心脏手术心肌损伤的影响：PRINCE随机临床试验

背景：重大非心脏手术术后心肌损伤和其他并发症的发生率很高。据报道，远程缺血预处理（RIPC）可减少这些并发症。然而，这种支持性证据缺乏稳健性。方法：在一项多国双盲试验中，我们随机分配接受非心脏手术的成人高危患者，在全身麻醉诱导后和术前接受RIPC或假RIPC。RIPC包括3个5分钟的缺血循环，每个循环之后是5分钟的再灌注，使用血压袖带膨胀至200 mmHg。主要终点是心肌损伤率，即术后肌钙蛋白水平高于参考值的最高99个百分位数。次要结局包括心肌梗死、中风、急性肾损伤、需要重症监护病房、住院时间和30天全因死亡率。结果：我们在8个国家的25家医院招募了1213名患者。我们随机将599人分配给RIPC， 614人分配给假RIPC。最常见的外科手术是腹部和胸部手术（406例，33.6%）。RIPC应用于上肢1014例（84.8%），下肢182例（15.2%）。RIPC组术后心肌损伤发生率215/566例（38.0%），假RIPC组术后心肌损伤发生率223/596例（37.4%）(相对危险度1.02；95%置信区间为0.88 ~ 1.18；P = 0.84)。在任何次要结果的发生率上没有显著差异。我们观察到11例肢体积点发作（RIPC组为10例[1.7%]，假RIPC组为1例[0.2%]），RIPC组为34例（6.0%）再入院，假RIPC组为20例（3.5%）。结论：在接受非心脏手术的成年患者中，RIPC并没有减少心肌损伤或其他术后并发症。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Circulation 医学-外周血管病

CiteScore

45.70

自引率

2.10%

发文量

1473

审稿时长

2 months

期刊介绍： Circulation is a platform that publishes a diverse range of content related to cardiovascular health and disease. This includes original research manuscripts, review articles, and other contributions spanning observational studies, clinical trials, epidemiology, health services, outcomes studies, and advancements in basic and translational research. The journal serves as a vital resource for professionals and researchers in the field of cardiovascular health, providing a comprehensive platform for disseminating knowledge and fostering advancements in the understanding and management of cardiovascular issues.