Effect of Supersaturated Oxygen Delivery on Infarct Size After Percutaneous Coronary Intervention in Acute Myocardial Infarction
| Autor: | Gregg W, Stone, Jack L, Martin, Menko-Jan, de Boer, Massimo, Margheri, Ezio, Bramucci, James C, Blankenship, D Christopher, Metzger, Raymond J, Gibbons, Barbara S, Lindsay, Bonnie H, Weiner, Alexandra J, Lansky, Mitchell W, Krucoff, Martin, Fahy, W John, Boscardin, J, Crump |
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| Rok vydání: | 2009 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Population Myocardial Infarction law.invention Electrocardiography Randomized controlled trial law Internal medicine Multicenter trial Angioplasty Humans Medicine Prospective Studies Myocardial infarction Angioplasty Balloon Coronary education Creatine Kinase Aged education.field_of_study Dose-Response Relationship Drug medicine.diagnostic_test business.industry Percutaneous coronary intervention Bayes Theorem Middle Aged medicine.disease Troponin Oxygen Treatment Outcome medicine.anatomical_structure Cardiology Female Cardiology and Cardiovascular Medicine business Biomarkers Artery |
| Zdroj: | Circulation: Cardiovascular Interventions. 2:366-375 |
| ISSN: | 1941-7632 1941-7640 |
| Popis: | 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 (SSO 2 ) 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 SSO 2 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 SSO 2 . The pooled adjusted infarct size was 25% (7%, 42%) with control compared with 18.5% (3.5%, 34.5%) after SSO 2 ( P Wilcoxon =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 SSO 2 by intention-to-treat, and 5.1�1.5% for control and 4.7�1.5% for SSO 2 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 SSO 2 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 |
| Databáze: | OpenAIRE |
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