Columbia University Medical Center, New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY 10022, USA.
Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.
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.
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).
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.
ST 段抬高型心肌梗死患者经皮冠状动脉介入治疗后心肌挽救往往不理想。一项先前试验（AMIHOT I）的事后亚组分析表明，在早期接受治疗的大面积 ST 段抬高型心肌梗死患者中，冠状动脉内输送超饱和氧（SSO（2））可能会减少梗死面积。
一项前瞻性、多中心试验纳入 301 例症状发作后 6 小时内行经皮冠状动脉介入治疗的前壁 ST 段抬高型心肌梗死患者，随机分为左前降支梗死区（n=222）接受 90 分钟的冠状动脉内 SSO（2）输注或对照组（n=79）。主要疗效指标为意向治疗人群的梗死面积（优势检验效能），主要安全性指标为意向治疗和方案人群 30 天内的复合主要不良心血管事件（非劣效性检验效能），采用贝叶斯层次模型允许对 AMIHOT I 中的部分证据进行汇总。在 AMIHOT II 中，281 例接受 tc-99m-sestamibi 单光子发射计算机断层扫描数据的随机患者中，与对照组相比，SO（2）治疗后中位数（四分位距）梗死面积为 26.5%（8.5%，44%），而对照组为 20%（6%，37%）。调整后的累积梗死面积为对照组 25%（7%，42%），SO（2）治疗后为 18.5%（3.5%，34.5%）（P（Wilcoxon）=0.02；SO（2）的优势后验概率为 96.9%）。意向治疗的 30 天平均（+/-SE）主要不良心血管事件发生率为对照组 5.0+/-1.4%，SO（2）组为 5.9+/-1.4%，方案分析的对照组为 5.1+/-1.5%，SO（2）组为 4.7+/-1.5%（非劣效性后验概率分别为 99.5%和 99.9%）。
在症状发作后 6 小时内行经皮冠状动脉介入治疗的前壁 ST 段抬高型心肌梗死患者中，将 SSO（2）输注到左前降支梗死区可显著减少梗死面积，30 天的主要不良心血管事件发生率非劣效。
临床试验注册-ClinicalTrials.gov 标识符：NCT00175058。
