Published online before print September 15, 2009, doi: 10.1161/CIRCINTERVENTIONS.108.840066
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Original Articles |
Effect of Supersaturated Oxygen Delivery on Infarct Size After Percutaneous Coronary Intervention in Acute Myocardial Infarction
From the Columbia University Medical Center (G.W.S., A.J.L., M.F.), New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY; Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital (J.L.M.), Main Line Health, Bryn Mawr, Pa; Isala Clinics Weezenlanden (M.J.D.), Zwolle, the Netherland; Universitaria di Careggi (M.M.), Florence, Italy; Policlinico San Matteo (E.B.), Pavia, Italy; Geisinger Medical Center (J.C.B.), Danville, Pa; Wellmont Holston Med Center (D.C.M.), Kingsport, Tenn; Mayo Clinic Foundation (R.J.G.), Rochester, Minn; TherOx, Inc. (B.S.L.), Irvine, Calif; Worcester Medical Center (B.H.W.), Worcester, Mass; Duke Clinical Research Institute (M.W.K.), Durham, NC; and University of California (W.J.B.), San Francisco, San Francisco, Calif.
Correspondence to Gregg W. Stone, MD, Columbia University Medical Center, New York-Presbyterian Hospital, the Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New York, NY 10022. E-mail gs2184{at}columbia.edu
Received December 1, 2008; accepted July 30, 2009.
Background— Myocardial salvage is often suboptimal after percutaneous coronary intervention in ST-segment elevation myocardial infarction. Posthoc subgroup analysis from a previous trial (AMIHOT I) suggested that intracoronary delivery of supersaturated oxygen (SSO2) may reduce infarct size in patients with large ST-segment elevation myocardial infarction treated early.
Methods and Results— A prospective, multicenter trial was performed in which 301 patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset were randomized to a 90-minute intracoronary SSO2 infusion in the left anterior descending artery infarct territory (n=222) or control (n=79). The primary efficacy measure was infarct size in the intention-to-treat population (powered for superiority), and the primary safety measure was composite major adverse cardiovascular events at 30 days in the intention-to-treat and per-protocol populations (powered for noninferiority), with Bayesian hierarchical modeling used to allow partial pooling of evidence from AMIHOT I. Among 281 randomized patients with tc-99m-sestamibi single-photon emission computed tomography data in AMIHOT II, median (interquartile range) infarct size was 26.5% (8.5%, 44%) with control compared with 20% (6%, 37%) after SSO2. The pooled adjusted infarct size was 25% (7%, 42%) with control compared with 18.5% (3.5%, 34.5%) after SSO2 (PWilcoxon=0.02; Bayesian posterior probability of superiority, 96.9%). The Bayesian pooled 30-day mean (±SE) rates of major adverse cardiovascular events were 5.0±1.4% for control and 5.9±1.4% for SSO2 by intention-to-treat, and 5.1±1.5% for control and 4.7±1.5% for SSO2 by per-protocol analysis (posterior probability of noninferiority, 99.5% and 99.9%, respectively).
Conclusions— Among patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset, infusion of SSO2 into the left anterior descending artery infarct territory results in a significant reduction in infarct size with noninferior rates of major adverse cardiovascular events at 30 days.
Clinical Trial Registration— clinicaltrials.gov Identifier: NCT00175058
Key Words: myocardial infarction • infarct size • angioplasty • reperfusion
CLINICAL PERSPECTIVE
The online-only Data Supplement is available at http://circinterventions.ahajournals.org/cgi/content/full/CIRCINTERVENTIONS.108.840066/DC1.
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