Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial.
Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial.
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DOI：
10.1016/j.ahj.2010.09.007
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发表时间：
2010-11
影响因子：
4.8
通讯作者：
Harrington, Robert A.
中科院分区：
文献类型：
--
作者：
Melloni, Chiara;Rao, Sunil V.;Povsic, Thomas J.;Melton, Laura;Kim, Raymond J.;Kilaru, Rakhi;Patel, Manesh R.;Talan, Mark;Ferrucci, Luigi;Longo, Dan L.;Lakatta, Edward G.;Najjar, Samer S.;Harrington, Robert A.
尽管在药物和经皮治疗方面取得了进展，急性心肌梗死（MI）仍然是导致死亡的主要原因。动物缺血/再灌注模型表明，单剂量促红细胞生成素（EPO）可能通过动员内皮祖细胞（EPCs）来减少梗死面积、减少细胞凋亡和增加新生血管。REVEAL是一项随机、双盲、安慰剂对照、多中心试验，评估促生成素对大心肌梗死患者梗死面积和左心室重构的影响。该试验包括剂量递增安全性阶段和单剂量有效性阶段，使用可接受的最高促生成素剂量高达60000单位。在再灌注成功后的4小时内，多达250名接受初级或抢救性经皮冠状动脉介入治疗（PCI）的STEMI患者将被随机分配到静脉注射促生成素或安慰剂组。主要研究终点是梗死面积占左室质量的百分比，在研究用药后2-6天通过心脏磁共振成像测量。次要终点将评估EPC数的变化和心室重构指标的变化。REVEAL试验将评估在急性STEMI患者成功接受抢救或首次PCI治疗的患者中，最高耐受单剂量epoetin α的安全性和有效性。
Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin (EPO) may reduce infarct size, decrease apoptosis, and increase neovascularization, possibly through mobilization of endothelial progenitor cells (EPCs). REVEAL is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the effects of epoetin alfa on infarct size and left ventricular (LV) remodeling in patients with large MIs. The trial comprises a dose-escalation safety phase and a single-dose efficacy phase using the highest acceptable epoetin alfa dose up to 60,000 units. Up to 250 STEMI patients undergoing primary or rescue percutaneous coronary intervention (PCI) will be randomized to intravenous epoetin alfa or placebo within 4 hours of successful reperfusion. The primary study endpoint is infarct size expressed as a percentage of LV mass, as measured by cardiac magnetic resonance imaging 2–6 days post study medication administration. Secondary endpoints will assess changes in EPC numbers and changes in indices of ventricular remodeling. The REVEAL trial will evaluate the safety and efficacy of the highest tolerated single dose of epoetin alfa in patients who have undergone successful rescue or primary PCI for acute STEMI.
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