Ellis Stephen G, Armstrong Paul, Betriu Amadeo, Brodie Bruce, Herrmann Howard, Montalescot Gilles, Neumann Franz-Josef, Smith John J, Topol Eric
Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Am Heart J. 2004 Apr;147(4):E16. doi: 10.1016/j.ahj.2003.07.025.
Percutaneous coronary intervention (PCI) has emerged as the strategy of choice in reestablishing effective flow in occluded infarct-related arteries in patients with acute myocardial infarction (MI) if it can be administered in a timely fashion. Patients who enter the catheterization laboratory with Thrombolysis In Myocardial Infarction (TIMI) grade 3 blood flow in the infarct-related vessel have better clinical outcomes than patients presenting with impaired flow. We hypothesize that a strategy of early pharmacologic reperfusion therapy with abciximab alone or in conjunction with reduced-dose reteplase, followed by PCI will improve the outcome of patients eligible for primary PCI.
The Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study is a 3000-patient, prospective, multicenter, randomized, double-blind, placebo-controlled trial. The study is designed to compare the efficacy and safety of early administration of reduced-dose reteplase and abciximab combination therapy or abciximab alone followed by PCI with abciximab alone administered just before PCI for acute MI. Patients will be randomized to one of these 2 facilitated PCI treatments or primary PCI in a 1:1:1 fashion. The primary efficacy end point of FINESSE is the composite of all-cause mortality or post-MI complications within 90 days of randomization. The primary safety outcome assessment will be Thrombolysis In Myocardial Infarction (TIMI) major bleeding.
The FINESSE study will answer important questions regarding the efficacy and safety of "upstream" medical therapy followed by planned intervention for patients with ST-elevation MI, potentially expanding the population eligible for a primary PCI approach. This study will also provide insight as to which facilitated regimen (reteplase/abciximab combination therapy or abciximab monotherapy) provides the best balance of efficacy and safety.
如果能及时实施，经皮冠状动脉介入治疗（PCI）已成为急性心肌梗死（MI）患者闭塞的梗死相关动脉重建有效血流的首选策略。梗死相关血管血流达到心肌梗死溶栓（TIMI）3级而进入导管室的患者，其临床结局优于血流受损的患者。我们假设，早期单独使用阿昔单抗或联合小剂量瑞替普酶进行药物再灌注治疗，随后进行PCI的策略，将改善适合直接PCI患者的结局。
促进再灌注速度以终止事件的辅助干预（FINESSE）研究是一项纳入3000例患者的前瞻性、多中心、随机、双盲、安慰剂对照试验。该研究旨在比较早期给予小剂量瑞替普酶与阿昔单抗联合治疗或单独使用阿昔单抗，随后进行PCI，与仅在PCI前给予阿昔单抗治疗急性心肌梗死的疗效和安全性。患者将以1:1:1的比例随机分为这两种辅助PCI治疗或直接PCI中的一种。FINESSE的主要疗效终点是随机分组后90天内全因死亡率或心肌梗死后并发症的复合终点。主要安全性结局评估将是心肌梗死溶栓（TIMI）大出血。
FINESSE研究将回答有关ST段抬高型心肌梗死患者“上游”药物治疗后进行计划性干预的疗效和安全性的重要问题，可能扩大适合直接PCI方法的人群。这项研究还将深入了解哪种辅助治疗方案（瑞替普酶/阿昔单抗联合治疗或阿昔单抗单药治疗）能提供最佳的疗效和安全性平衡。
