[TCT2008]AMIHOT II：过饱和氧化治疗能够减小梗死面积
来源：医心网 发布时间：2008-10-15 08:17
AMIHOT II: Supersaturated Oxygen Therapy Reduced Infarct Size
（北京协和医院 鲁勖 翻译）
关键词:
• 产品正在等待FDA的批准.
根据AMIHOT II研究的最新结果，过饱和氧化治疗能够有效降低梗死面积，其效果超过了一期PCI治疗。
来自哥伦比亚大学医疗中心心血管研究室的Gregg W. Stone教授说，过饱和氧化治疗也被成为SSO2, 它能够将梗死面积缩小6.5% （p=.023）。研究的一期终点包括梗死面积以及30天的主要不良心脏事件，前者采用意向治疗分析法，后者采用意向治疗分析法和完成治疗分析法进行。
通过左室射血分数（LVEF）来对患者分级后发现，过饱和氧化治疗对梗死面积有着显著缩小的效果。LVEF小于40%的患者其梗死面积比非治疗组缩小了12.5%（对照组35%：治疗组22.5%）。LVEF超过40%的患者，其梗死面积比非治疗组小了3%（对照组15.5%：治疗组12.5%）。
在意向治疗(Intent-to-Treat)终点中，不良反应的发生率在治疗组中为5.4%，对照组为3.8%。死亡率在治疗组中为1.8%，对照组为0.0%，而梗死复发的比例在治疗组中为1.8%，对照组中为2.5%。另外TVR率在治疗组中为3.6%，对照组为3.8%。
在完成治疗分析(Per Protocol)中，两组的MACE发生率均为3.8%，死亡率在治疗组中1.1%，对照组为0.0%。在梗死发生率为治疗组1.6%，对照组2.6%。TVR率在治疗组为2.7%，对照组3.8%。两组中均没有患者出现中风。
Stone及其同事们在四个国家（美国，加拿大，荷兰和意大利）的20个中心随机抽取了300名病例。前壁心梗且TIMI在0-2之间的患者接受PCI再灌注加支架治疗，如果这些患者在6小时内TIMI恢复到2-3之间则接受入组。其中222名患者在90分钟内接受过饱和氧化治疗，而另外79名患者则接受常规治疗。梗死面积通过SPECT Tc-99测定。
Stone指出：“当心梗出现在高危患者中，且成功的在6小时内进行了PCI手术的患者中，过饱和氧化治疗能够良好的保护梗死区域，降低梗死面积。”目前，这一产品正在等待FDA的批准。我们希望明年早些时候能够拿到批文，并借此帮助那些高危患者获得更好的预后，因为他们没有其他更多的治疗方式可以选择。
（来源：www.tctmd.com）
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Key Points:
By TCTMD Staff
Supersaturated oxygen therapy reduced infarct size beyond that achieved by primary PCI, according to results of the AMIHOT II study.
Supersaturated oxygen therapy, or SSO2, reduced infarct size 6.5% (P=.023; see Figure), said Gregg W. Stone, MD, professor of medicine at Columbia University Medical Center and chairman of the Cardiovascular Research Foundation in New York.
Primary endpoints of the study included intent-to-treat efficacy as measured by infarct size (to determine superiority), and both intent-to-treat and per-protocol 30-day major adverse cardiac events (to determine noninferiority).
Stratifying patients by baseline LVEF showed a marked absolute reduction in infarct size with SSO2 therapy. Patients with baseline LVEF ,40% had a reduction in median infarct size of 12.5% (35% in controls vs. 22.5% in the SSO2 group). Patients with a baseline LVEF >40% had a reduction in infarct size of 3% (15.5% in controls vs. 12.5% in SSO2).
In the intent-to-treat endpoint, (99.5% probability of noninferiority) adverse events occurred in 5.4% of patients in the SSO2 group vs. 3.8% in the control group (see Table 1). Mortality was 1.8% in the SSO2 group vs. 0.0% in the control group, while reinfarction occured in 1.8% in the SSO2 group vs. 2.5% in the control group. In addition, TVR occured in 3.6% in the SSO2 group vs. 3.8% in the control group.
In the per protocol MACE endpoint (99.9% probability of noninferiority), adverse events occurred in 3.8% in both groups (see Table 2); death occurred in 1.1% in the SSO2 group and 0.0% in the control group; reinfarction occurred in 1.6% in the SSO2 group and 2.6% in the control group; TVR occurred in 2.7% in the SSO2 group vs. 3.8% in the control group. No patients had a stroke in either of the major adverse cardiac events endpoints.
Stone and colleagues randomized over 300 patients at 20 sites in four countries (United States, Canada, Netherlands and Italy) between September 13, 2005, and May 26, 2007. Patients with anterior acute MI with TIMI 0-2 flow that was reperfused by PCI with stenting within six hours achieved TIMI 2-3 flow before randomization. There were 222 patients in the SSO2 cohort who received SSO2 for 90 minutes, while the remaining 79 were in the standard therapy cohort. Infarct size was measured by Tcffice:smarttags" />-99m-sestamibi SPECT. "Among high-risk patients with acute anterior MI undergoing successful PCI within six hours of symptom onset, infusion of SSO2 into the myocardial infarct territory results in a significant reduction in infarct size," he said.
Stone said this product is pending FDA approval; data has been submitted to the FDA. "Hopefully early next year at some point this technology will be in your hand to help those patients at highest risk for which there really is no other therapeutic option," he said. Disclosures: Dr. Stone reports receiving research support from TherOx Inc. |
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