Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Trials. 2010 Sep 21;11:89. doi: 10.1186/1745-6215-11-89.
In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.
METHODS/DESIGN: The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.
The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.
trialregister.nl NTR1108.
在直接经皮冠状动脉介入治疗（PCI）的背景下，非梗死相关动脉的慢性完全闭塞患者最近被确定为高危亚组。对于直接 PCI 后，非梗死相关动脉的慢性完全闭塞患者，是否应在最佳药物治疗的基础上，进一步行慢性完全闭塞的经皮冠状动脉介入治疗，目前尚不清楚。可能的有益效果包括减少不良的左心室重构和保留整体左心室功能，并在未来的冠状动脉事件中改善临床结局。
方法/设计：经皮冠状动脉介入治疗后评估 Xience V 和左心室功能对 ST 段抬高型心肌梗死患者（EXPLORE）试验是一项随机、前瞻性、多中心、双臂试验，终点评估采用盲法。300 例直接 PCI 治疗 ST 段抬高型心肌梗死伴非梗死相关动脉慢性完全闭塞的患者随机分为两组，一组在 7 天内行慢性完全闭塞的选择性经皮冠状动脉介入治疗，另一组接受标准药物治疗。在随机分组为介入组的患者中，将使用依维莫司洗脱冠状动脉支架。主要终点是 4 个月时心脏磁共振成像评估的左心室射血分数和左心室舒张末期容积。临床随访将持续 5 年。
正在进行的 EXPLORE 试验是第一项针对直接 PCI 治疗 ST 段抬高型心肌梗死患者后，非梗死相关动脉的慢性完全闭塞再通是否可导致更好的保留残余左心室射血分数、减少舒张末期容积和改善临床结局的随机临床试验。
trialregister.nl NTR1108。
