Journal article

Publication year: 2015

Pages: 1397-1407

Journal: New England Journal of Medicine

Volume number: 373

Issue number: 15

ISSN: 0028-4793

eISSN: 1533-4406

Open access status: Green

DOI Link: https://doi.org/10.1056/NEJMoa1413579

Publisher: Massachusetts Medical Society

Abstract: 

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.

Harvard Citation style: Meybohm, P., Bein, B., Brosteanu, O., Cremer, J., Gruenewald, M., Stoppe, C., et al. (2015) A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery, New England Journal of Medicine, 373(15), pp. 1397-1407. https://doi.org/10.1056/NEJMoa1413579

APA Citation style: Meybohm, P., Bein, B., Brosteanu, O., Cremer, J., Gruenewald, M., Stoppe, C., Coburn, M., Schaelte, G., Boening, A., Niemann, B., Roesner, J., Kletzin, F., Strouhal, U., Reyher, C., Laufenberg-Feldmann, R., Ferner, M., Brandes, I., Bauer, M., Stehr, S., ...Zacharowski, K. (2015). A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. New England Journal of Medicine. 373(15), 1397-1407. https://doi.org/10.1056/NEJMoa1413579