Rationale and Design of the POSTEMI (Postconditioning in ST-Elevation Myocardial Infarction) Study

Abstract

Rapid reperfusion of the infarct-related coronary artery is essential in the treatment of acute ST-elevation myocardial infarction (STEMI). Paradoxically, restoration of the blood flow to the ischemic area may result in further injury to the myocardium. This phenomenon is described as ‘ischemia/reperfusion injury’ and the pathophysiological mechanisms are not fully elucidated. A cardioprotective effect of ischemic postconditioning (short repetitive cycles of reperfusion and re-occlusion) has been demonstrated in experimental studies and in pilot studies on patients with acute STEMI treated with primary percutaneous coronary intervention. We present the study design of the Postconditioning in ST-Elevation Myocardial Infarction (POSTEMI) study, which is a prospective, randomized, open-label clinical trial with blinded endpoint evaluation designed to evaluate the effect of postconditioning on final infarct size. Patients with acute STEMI with symptoms of less than 6 h and proximal or mid-coronary artery occlusion will be included. The primary endpoint is infarct size, assessed by cardiac MRI after 4 months. The secondary endpoints are to evaluate the effect of postconditioning on TIMI myocardial perfusion grade, resolution of ST-segment elevation, release of markers of ischemia, left ventricular function and final infarct size related to the area at risk. A total of 260 patients will be included in the study.

Local Ischemic Postconditioning during Primary Percutaneous Coronary Intervention: A Meta-Analysis

“…Five studies were excluded in the full text evaluation for the following reasons: 1 was possibly a duplicate [7], 1 was a retrospective chart review [8], 1 lacked any of our requisite outcomes [9], 1 was an ongoing study [10] and all the data of the 5th study were presented as medians and 25th and 75th percentiles [11]. Finally, by screening the whole article, we selected 13 studies for meta-analysis.…”

Ischemic Postconditioning with Lactate-Enriched Blood in Patients with Acute Myocardial Infarction

“…Limalanathan et al [1] and Tarantini et al [2] reported study designs for examining the protective effects of postconditioning in patients with acute myocardial infarction (MI) in volume 116 of Cardiology in 2010. However, recent clinical trials have not elucidated the protective effects of postconditioning [3,4].…”

Remote Ischemic Postconditioning: Does It Protect against Ischemic Damage in Percutaneous Coronary Revascularization? Justification and Design of a Randomized Placebo-Controlled Clinical Trial

“…Ischemic postconditioning has been shown to be efficient in the reduction of the myocardial damage that is associated with reperfusion in STACS, with promising initial results in animals and humans [6]. Some of these studies have included patients with STACS undergoing primary angioplasty who were randomized to receive or not receive short periods of ischemia-reperfusion produced by the inflation of the angioplasty balloon to reduce the size of the resulting infarct in comparison with a control group [7,8]. Patients with STACS may also benefit from remote ischemic preconditioning using cycles of ischemia-reperfusion in the limbs just before or after the primary angioplasty (remote periconditioning) [9].…”