Author Interviews, Heart Disease, NEJM, Surgical Research / 05.10.2015
Multicenter Trial Fails To Show Benefit of Remote Ischemic Preconditioning Prior To Heart Surgery
MedicalResearch.com Interview with:
Prof. Dr. med. Patrick Meybohm, MHBAConsultant for Anesthesiology and Intensive Care Medicine
University Hospital Frankfurt
Dept. Of Anesthesiology, Intensive Care Medicine and Pain Therapy
Frankfurt Germany
Medical Research: What is the background for this study? What are the main findings?
Prof. Meybohm: 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.
We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass. 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.
A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-Remote ischemic preconditioning 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.


























