A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery

被引:509
作者
Meybohm, P. [1 ,2 ]
Bein, B. [2 ]
Brosteanu, O. [4 ]
Cremer, J. [3 ]
Gruenewald, M. [2 ]
Stoppe, C. [7 ]
Coburn, M. [7 ]
Schaelte, G. [7 ]
Boening, A. [8 ]
Niemann, B. [8 ]
Roesner, J. [9 ]
Kletzin, F. [9 ]
Strouhal, U. [1 ]
Reyher, C. [1 ]
Laufenberg-Feldmann, R. [10 ]
Ferner, M. [10 ]
Brandes, I. F. [11 ]
Bauer, M. [11 ]
Stehr, S. N. [12 ,13 ]
Kortgen, A. [12 ,13 ]
Wittmann, M. [14 ]
Baumgarten, G. [14 ]
Meyer-Treschan, T. [15 ]
Kienbaum, P. [15 ]
Heringlake, M. [16 ]
Schoen, J. [16 ]
Sander, M. [17 ]
Treskatsch, S. [17 ]
Smul, T. [18 ]
Wolwender, E. [18 ]
Schilling, T. [19 ]
Fuernau, G. [5 ]
Hasenclever, D. [6 ]
Zacharowski, K. [1 ]
机构
[1] Univ Hosp Frankfurt, Dept Anesthesiol, Intens Care Med & Pain Therapy, D-60590 Frankfurt, Germany
[2] Univ Hosp Schleswig Holstein, Dept Anesthesiol & Intens Care Med, Kiel, Germany
[3] Univ Hosp Schleswig Holstein, Dept Cardiovasc Surg, Kiel, Germany
[4] Univ Leipzig, Ctr Heart, Clin Trial Ctr, D-04109 Leipzig, Germany
[5] Univ Leipzig, Ctr Heart, Dept Internal Med Cardiol, D-04109 Leipzig, Germany
[6] Univ Leipzig, Inst Med Informat Stat & Epidemiol, D-04109 Leipzig, Germany
[7] Univ Hosp Aachen, Dept Anesthesiol, Aachen, Germany
[8] Univ Giessen, Dept Cardiovasc Surg, D-35390 Giessen, Germany
[9] Univ Hosp Rostock, Clin Anesthesiol & Intens Care Med, Rostock, Germany
[10] Johannes Gutenberg Univ Mainz, Med Ctr, Dept Anesthesiol, Mainz, Germany
[11] Univ Hosp Gottingen, Dept Anesthesiol & Intens Care Med, Gottingen, Germany
[12] Jena Univ Hosp, Dept Anesthesiol & Intens Care Med, Jena, Germany
[13] Jena Univ Hosp, Ctr Sepsis Control & Care, Jena, Germany
[14] Univ Hosp Bonn, Dept Anesthesiol & Intens Care Med, Bonn, Germany
[15] Univ Hosp Dusseldorf, Dept Anesthesiol & Intens Care Med, Dusseldorf, Germany
[16] Med Univ Lubeck, Dept Anesthesiol & Intens Care Med, Lubeck, Germany
[17] Charite, Dept Anesthesiol & Intens Care Med, D-13353 Berlin, Germany
[18] Univ Hosp Wurzburg, Dept Anesthesiol, Wurzburg, Germany
[19] Univ Hosp Magdeburg, Dept Anesthesiol, Magdeburg, Germany
关键词
BYPASS GRAFT-SURGERY; RANDOMIZED CONTROLLED-TRIAL; ACUTE KIDNEY INJURY; CARDIAC-SURGERY; MYOCARDIAL-INFARCTION; DOUBLE-BLIND; METAANALYSIS; THERAPY; CARDIOPROTECTION; COMPLICATIONS;
D O I
10.1056/NEJMoa1413579
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium. No RIPC-related adverse events were observed. CONCLUSIONS Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery.
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收藏
页码:1397 / 1407
页数:11
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