Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A prospective,randomized,sham-controlled phase II clinical trial

Background-remote ischemic preconditioning (ripc) has been shown to reduce infarct size in animal models. we hypothesized that ripc before an elective vascular operation would reduce the incidence and amount of a postoperative rise of the cardiac troponin level. methods and results-cardiac remote ischemic preconditioning prior to elective vascular surgery (cripes) was a prospective,randomized,sham-controlled phase 2 trial using ripc before elective vascular procedures. the ripc protocol consisted of 3 cycles of 5-minute forearm ischemia followed by 5 minutes of reperfusion. the primary endpoint was the proportion of subjects with a detectable increase in cardiac troponin i (ctni) and the distribution of such increases. from june 2011 to september 2015,201 male patients (69±7,years) were randomized to either ripc (n=100) or a sham procedure (n=101). indications for vascular surgery included an expanding abdominal aortic aneurysm (n=115),occlusive peripheral arterial disease of the lower extremities (n=37),or internal carotid artery stenosis (n=49). of the 201 patients,47 (23.5%) had an increase in ctni above the upper reference limit within 72 hours of the vascular operation,with no statistically significant difference between those patients assigned to ripc (n=22; 22.2%) versus sham procedure (n=25; 24.7%; p=0.67). among the cohort with increased ctni,the median peak values (interquartile range) in the ripc and control group were 0.048 (0.004-0.174) and 0.017 (0.003-0.105),respectively (p=0.54). conclusions-in this randomized,controlled trial of men with increased perioperative cardiac risks,elevation in cardiac troponins was common following vascular surgery,but was not reduced by a strategy of ripc. © 2016 the authors.