Joo-Yong Hahn1, Young Bin Song, Eun Kyoung Kim, Cheol Woong Yu, Jang-Whan Bae, Woo-Young Chung, Seung-Hyuk Choi, Jin-Ho Choi, Jang-Ho Bae, Kyung Joo An, Jong-Seon Park, Ju Hyeon Oh, Sang-Wook Kim, Jin-Yong Hwang, Jae Kean Ryu, Hun Sik Park, Do-Sun Lim, Hyeon-Cheol Gwon. 1. Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (J.-Y. Hahn; Y.B.S., E.K.K., S.-H.C., J.-H.C., H.-C.G.); Sejong General Hospital, Bucheon, Korea (C.W.Y.); Chungbuk National University Hospital, Cheongju, Korea (J.-W.B.); Seoul National University, Boramae Medical Center, Seoul, Korea (W.-Y.C.); Konyang University Hospital, Daejon, Korea (J.-H.B.); KEPCO Medical Center, Seoul, Korea (K.J.A.); Yeungnam University Hospital, Daegu, Korea (J.-S.P.); Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea (J.H.O.); Chung-Ang University Hospital, Seoul, Korea (S.-W.K.); Gyeongsang National University Hospital, Jinju, Korea (J.-Y. Hwang); Daegu Catholic University Medical Center, Daegu, Korea (J.K.R.); Kyungpook National University Hospital, Daegu, Korea (H.S.P.); and Korea University Anam Hospital, Seoul, Korea (D.-S.L.).
Abstract
BACKGROUND:Ischemic postconditioning has been reported to reduce infarct size in patients with ST-segment-elevation myocardial infarction. However, cardioprotective effects of postconditioning have not been demonstrated in a large-scale trial. METHODS AND RESULTS: We performed a multicenter, prospective, randomized, open-label, blinded end-point trial. A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction within 12 hours after symptom onset were randomly assigned to the postconditioning group or to the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow as follows: The angioplasty balloon was positioned at the culprit lesion and inflated 4 times for 1 minute with low-pressure (<6 atm) inflations, each separated by 1 minute of deflation. The primary end point was complete ST-segment resolution (percentage resolution of ST-segment elevation >70%) measured at 30 minutes after PCI. Complete ST-segment resolution occurred in 40.5% of patients in the postconditioning group and 41.5% of patients in the conventional PCI group (absolute difference, -1.0%; 95% confidence interval, -8.4 to 6.4; P=0.79). The rate of myocardial blush grade of 0 or 1 and the rate of major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis) at 30 days did not differ significantly between the postconditioning group and the conventional PCI group (17.2% versus 22.4% [P=0.20] and 4.3% versus 3.7% [P=0.70], respectively). CONCLUSION:Ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment-elevation myocardial infarction undergoing primary PCI with current standard practice.
RCT Entities:
BACKGROUND: Ischemic postconditioning has been reported to reduce infarct size in patients with ST-segment-elevation myocardial infarction. However, cardioprotective effects of postconditioning have not been demonstrated in a large-scale trial. METHODS AND RESULTS: We performed a multicenter, prospective, randomized, open-label, blinded end-point trial. A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction within 12 hours after symptom onset were randomly assigned to the postconditioning group or to the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow as follows: The angioplasty balloon was positioned at the culprit lesion and inflated 4 times for 1 minute with low-pressure (<6 atm) inflations, each separated by 1 minute of deflation. The primary end point was complete ST-segment resolution (percentage resolution of ST-segment elevation >70%) measured at 30 minutes after PCI. Complete ST-segment resolution occurred in 40.5% of patients in the postconditioning group and 41.5% of patients in the conventional PCI group (absolute difference, -1.0%; 95% confidence interval, -8.4 to 6.4; P=0.79). The rate of myocardial blush grade of 0 or 1 and the rate of major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis) at 30 days did not differ significantly between the postconditioning group and the conventional PCI group (17.2% versus 22.4% [P=0.20] and 4.3% versus 3.7% [P=0.70], respectively). CONCLUSION: Ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment-elevation myocardial infarction undergoing primary PCI with current standard practice.