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A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery

作者:Patrick Meybohm, Berthold Bein, Oana Brosteanu, Jochen T. Cremer, Matthias Gruenewald, Christian Stoppe, Mark Coburn, G. Schaelte, Andreas Böning, Bernd Niemann, Jan P. Roesner, Frank Kletzin, Ulrich Strouhal, Christian Reyher, Rita Laufenberg–Feldmann, Marion Ferner, Ivo Florian Brandes, Martin C.R. Bauer, Sebastian N. Stehr, Andreas Kortgen, Mária Wittmann, Georg Baumgarten, Tanja Meyer‐Treschan, Peter Kienbaum, Matthias Heringlake, Julika Schön, Michael Sander, Sascha Treskatsch, Thorsten M. Smul, Ewa Wolwender, Thomas Schilling, Georg Friedrich Fuernau, Dirk Hasenclever, Kai D. Zacharowski · 发表于:New England Journal of Medicine · 年份:2015 · DOI:10.1056/nejmoa1413579 · 被引用次数:645 · 研究领域:Cardiac Ischemia and Reperfusion、Organ Transplantation Techniques and Outcomes、Cardiac and Coronary Surgery Techniques

BACKGROUND: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains. METHODS: We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90. RESULTS: A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-RIPC group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis. No significant difference...