NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction

Circ Res. 2019 Mar;124(5):769-778. doi: 10.1161/CIRCRESAHA.118.314060.

Abstract

Rationale: Postconditioning at the time of primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction may reduce infarct size and improve myocardial salvage. However, clinical trials have shown inconsistent benefit.

Objective: We performed the first National Heart, Lung, and Blood Institute-sponsored trial of postconditioning in the United States using strict enrollment criteria to optimize the early benefits of postconditioning and assess its long-term effects on left ventricular (LV) function.

Methods and results: We randomized 122 ST-segment-elevation myocardial infarction patients to postconditioning (4, 30 seconds PTCA [percutaneous transluminal coronary angioplasty] inflations/deflations)+PCI (n=65) versus routine PCI (n=57). All subjects had an occluded major epicardial artery (thrombolysis in myocardial infarction=0) with ischemic times between 1 and 6 hours with no evidence of preinfarction angina or collateral blood flow. Cardiac magnetic resonance imaging measured at 2 days post-PCI showed no difference between the postconditioning group and control in regards to infarct size (22.5±14.5 versus 24.0±18.5 g), myocardial salvage index (30.3±15.6% versus 31.5±23.6%), or mean LV ejection fraction. Magnetic resonance imaging at 12 months showed a significant recovery of LV ejection fraction in both groups (61.0±11.4% and 61.4±9.1%; P<0.01). Subjects randomized to postconditioning experienced more favorable remodeling over 1 year (LV end-diastolic volume =157±34 to 150±38 mL) compared with the control group (157±40 to 165±45 mL; P<0.03) and reduced microvascular obstruction ( P=0.05) on baseline magnetic resonance imaging and significantly less adverse LV remodeling compared with control subjects with microvascular obstruction ( P<0.05). No significant adverse events were associated with the postconditioning protocol and all patients but one (hemorrhagic stroke) survived through 1 year of follow-up.

Conclusions: We found no early benefit of postconditioning on infarct size, myocardial salvage index, and LV function compared with routine PCI. However, postconditioning was associated with improved LV remodeling at 1 year of follow-up, especially in subjects with microvascular obstruction.

Clinical trial registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01324453.

Keywords: magnetic resonance imaging; myocardial infarction; percutaneous coronary intervention; postconditioning; reperfusion injury.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Coronary Circulation*
  • Female
  • Humans
  • Ischemic Postconditioning / adverse effects
  • Ischemic Postconditioning / methods*
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Minnesota
  • Myocardium / pathology
  • National Heart, Lung, and Blood Institute (U.S.)
  • Percutaneous Coronary Intervention* / adverse effects
  • Recovery of Function
  • ST Elevation Myocardial Infarction / diagnostic imaging
  • ST Elevation Myocardial Infarction / physiopathology
  • ST Elevation Myocardial Infarction / therapy*
  • Stroke Volume
  • Time Factors
  • Tissue Survival
  • Treatment Outcome
  • United States
  • Ventricular Function, Left
  • Ventricular Remodeling

Associated data

  • ClinicalTrials.gov/NCT01324453