Fung Anthony Y, Saw Jacqueline, Starovoytov Andrew, Densem Cameron, Jokhi Percy, Walsh Simon J, Fox Rebecca S, Humphries Karin H, Aymong Eve, Ricci Donald R, Webb John G, Hamburger Jaap N, Carere Ronald G, Buller Christopher E
Vancouver General Hospital, British Columbia, Canada.
J Am Coll Cardiol. 2009 Mar 10;53(10):837-45. doi: 10.1016/j.jacc.2008.09.060.
The purpose of this study was to assess whether the early discontinuation of eptifibatide infusion in nonemergent percutaneous coronary intervention (PCI) is associated with a higher frequency of periprocedural ischemic myonecrosis.
The recommended regimen for eptifibatide is a double bolus followed by an infusion for 18 h. It is not known whether the infusion can be shortened if the PCI is uncomplicated.
We enrolled 624 patients with stable angina, acute coronary syndrome, or recent ST-segment elevation myocardial infarction (>48 h) who underwent successful coronary stenting and received eptifibatide. Patients were randomly assigned to receive either an 18-h infusion or an abbreviated infusion of <2 h. The primary end point was the incidence of periprocedural myonecrosis defined as troponin-I elevation >0.26 microg/l. Secondary end points included death, myocardial infarction, urgent target vessel revascularization at 30 days, and in-hospital major bleeding using the REPLACE-2 (Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events) trial criteria.
The incidence of periprocedural myonecrosis was 30.1% in the <2-h group versus 28.3% in the 18-h group (mean difference: 1.8%; upper bound of 95% confidence interval: 7.8%; p < 0.012 for noninferiority). The 30-day incidence of myocardial infarction, death, and target vessel revascularization was similar in both groups (p = NS). Major bleeding was less frequent in the <2-h group (1.0% vs. 4.2%, p = 0.02).
After uncomplicated PCI, eptifibatide infusion can be abbreviated safely to <2 h. It is not inferior to the standard 18-h infusion in preventing ischemic outcome, and it may be associated with less major bleeding. (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention [BRIEF PCI]; NCT00111566).
本研究旨在评估在非急诊经皮冠状动脉介入治疗（PCI）中早期停用依替巴肽输注是否与围手术期缺血性肌坏死的更高发生率相关。
依替巴肽的推荐方案是双剂量推注后输注18小时。对于无并发症的PCI，输注时间是否可以缩短尚不清楚。
我们纳入了624例患有稳定型心绞痛、急性冠状动脉综合征或近期ST段抬高型心肌梗死（>48小时）且成功进行冠状动脉支架置入并接受依替巴肽治疗的患者。患者被随机分配接受18小时输注或少于2小时的简化输注。主要终点是围手术期肌坏死的发生率，定义为肌钙蛋白I升高>0.26微克/升。次要终点包括死亡、心肌梗死、30天紧急靶血管血运重建以及使用REPLACE-2（PCI中Angiomax与减少临床事件的随机评估）试验标准的院内大出血。
少于2小时组围手术期肌坏死的发生率为30.1%，而18小时组为28.3%（平均差异：1.8%；95%置信区间上限：7.8%；非劣效性p<0.012）。两组30天心肌梗死、死亡和靶血管血运重建的发生率相似（p=无显著性差异）。少于2小时组大出血的发生率较低（1.0%对4.2%，p=0.02）。
在无并发症的PCI后，依替巴肽输注可安全缩短至少于2小时。在预防缺血性结局方面，它不劣于标准的18小时输注，并且可能与较少的大出血相关。（经皮冠状动脉介入治疗后依替巴肽的简化输注[BRIEF PCI]；NCT00111566）
