05 Oct 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
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.
Medical Research: What should clinicians and patients take away from your report?
Prof. Meybohm: It has been suggested that the technique induces adaptive responses that markedly enhance the ability of vital organs (e.g., the heart) to withstand prolonged ischemic and reperfusion injury. Initial laboratory studies ofRemote ischemic preconditioning led to encouraging proof-of-principle human studies. Initial studies that used surrogate end points in patients. Other trials of RIPC in cardiac surgery failed to show beneficial effects. Possible explanations for the divergent results of the trials are that most of the positive trials used surrogate end points, were conducted at a single center, used a single-blind design, had a small sample size, or were not standardized with respect to the anesthesia regimen.
In this multicenter, double-blind, randomized trial involving 1403 patients who were scheduled to undergo elective cardiac surgery, upper- limb Remote Ischemic Preconditioning did not show a relevant clinical benefit.
Clinicians and patients may take away that any conclusion from smaller pilot trials should not be drawn until the results of a larger multi centre trial has been published (not) confirming previous findings, before clinical standard will be changed.
Medical Research: What recommendations do you have for future research as a result of this study?
Prof. Meybohm: Generalizability may be affected owing to the use of one type of anesthesia (propofol), which is uncommon in some areas, and owing to our exclusion criteria (e.g., urgent surgery, reoperations, recent myocardial infarction, and severe renal or liver disease). Other Remote ischemic preconditioning protocols (e.g., involving lower-limb RIPC, a longer duration of ischemia, or more cycles) may still be protective.
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Prof. Dr. med. Patrick Meybohm, MHBA (2015). Multicenter Trial Fails To Show Benefit of Remote Ischemic Preconditioning Prior To Heart Surgery