Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management - One-year results from the ACUITY trial
Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management - One-year results from the ACUITY trial
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DOI：
10.1001/jama.298.21.2497
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发表时间：
2007-12-05
影响因子：
120.7
通讯作者：
Pocock, Stuart J.
中科院分区：
文献类型：
--
作者：
Stone, Gregg W.;Ware, James H.;Pocock, Stuart J.
研究背景在ACUITY试验中，中、高危急性冠脉综合征（ACS）患者接受早期侵入性治疗后30天随访，比伐卢定单药治疗与肝素加糖蛋白（GP）IIb/IIIa抑制剂相比，不良缺血事件发生率非劣效，大出血发生率降低。对接受经皮冠状动脉介入治疗（PCI）的患者选择性地延迟上游使用GP IIb/IIIa抑制剂导致严重出血的显著减少，尽管不能排除复合缺血的小幅增加。在17个国家的450个学术和社区机构进行了为期1年的临床随访的开放标签试验。在2003年8月23日至2005年12月5日期间，共纳入了13819例接受侵入性治疗的中高危ACS患者。干预患者被分为肝素+GP IIb/IIIa抑制剂组（n= 4603）、比伐卢定+GP IIb/IIIa抑制剂组（n= 4604）或比伐卢定单药治疗组（n= 4612）。在这些患者中，4605例被分配到常规上游GP IIb/IIIa给药组，4602例被推迟到选择性GP IIb/IIIa抑制剂给药组。主要结果测量复合缺血（死亡、心肌梗塞、结果肝素+GP IIb/IIIa抑制剂组1年时复合缺血发生率为15.4%，比伐卢定联合GP IIb/ IIIa抑制剂组（与肝素联合GP IIb/ IIIa抑制剂组相比，HR，1.05; 95% CI，0.95 - 1.16; P= 0.35），比伐卢定单药治疗组为16.2%（HR，1.06; 95% CI，0.95-1.17; P= 0.29）。1年时，肝素+GP IIb/ IIIa抑制剂组患者的死亡率估计为3.9%，比伐卢定+GP IIb/ IIIa抑制剂组为3.9%（HR，0.99; 95% CI，0.80-1.22; P= 0.92），3.8%分配给比伐卢定单药治疗（HR，0.96; 95% CI，0.77-1.18; P= 0.67）。16.3%的延迟给药患者发生复合性缺血，而15.2%的上游给药患者发生复合性缺血（HR为1.08; 95% CI为0.97-1.20; P= 0.15）。结论在1年时，中度和高度缺血患者的复合缺血率或死亡率无统计学显著差异，结果发现，接受3种治疗方法侵入性治疗的危险ACS患者中，接受常规上游GP IIb/ IIIa抑制剂给药的患者与接受PCI治疗的患者推迟使用GP IIb/ IIIa抑制剂的患者之间，复合缺血的发生率无统计学显著差异。政府标识符：NCT 00093158。
Context At 30-day follow-up, patients with moderate-and high-risk acute coronary syndromes (ACS) undergoing early invasive treatment in the ACUITY trial with bivalirudin monotherapy vs heparin plus glycoprotein ( GP) IIb/IIIa inhibitors had noninferior rates of adverse ischemic events with reduced rates of major bleeding. Deferred upstream use of GP IIb/IIIa inhibitors for selective administration to patients undergoing percutaneous coronary intervention (PCI) resulted in a significant reduction in major bleeding, although a small increase in composite ischemia could not be excluded.Objective To determine 1-year ischemic outcomes for patients in the ACUITY trial.Design, Setting, and Patients A prospective, randomized, open-label trial with 1-year clinical follow-up at 450 academic and community-based institutions in 17 countries. A total of 13 819 patients with moderate- and high-risk ACS undergoing invasive treatment were enrolled between August 23, 2003, and December 5, 2005.Interventions Patients were assigned to heparin plus GP IIb/IIIa inhibitors (n= 4603), bivalirudin plus GP IIb/IIIa inhibitors ( n= 4604), or bivalirudin monotherapy ( n= 4612). Of these patients, 4605 were assigned to routine upstream GP IIb/IIIa administration and 4602 were deferred to selective GP IIb/IIIa inhibitor administration.Main Outcome Measure Composite ischemia ( death, myocardial infarction, or unplanned revascularization for ischemia) at 1 year.Results Composite ischemia at 1 year occurred in 15.4% of patients assigned to heparin plus GP IIb/IIIa inhibitors and 16.0% assigned to bivalirudin plus GP IIb/ IIIa inhibitors ( compared with heparin plus GP IIb/ IIIa inhibitors, HR, 1.05; 95% Cl, 0.951.16; P=.35), and 16.2% assigned to bivalirudin monotherapy (HR, 1.06; 95% Cl, 0.95-1.17; P=.29). Mortality at 1 year occurred in an estimated 3.9% of patients assigned to heparin plus GP IIb/ IIIa inhibitors, 3.9% assigned to bivalirudin plus GP IIb/ IIIa inhibitors ( HR, 0.99; 95% Cl, 0.80-1.22; P=.92), and 3.8% assigned to bivalirudin monotherapy ( HR, 0.96; 95% Cl, 0.77-1.18; P=.67). Composite ischemia occurred in 16.3% of patients assigned to deferred use compared with 15.2% of patients assigned to upstream administration ( HR, 1.08; 95% Cl, 0.97-1.20; P=.15).Conclusions At 1 year, no statistically significant difference in rates of composite ischemia or mortality among patients with moderate- and high-risk ACS undergoing invasive treatment with the 3 therapies was found. There was no statistically significant difference in the rates of composite ischemia between patients receiving routine upstream administration of GP IIb/ IIIa inhibitors vs deferring their use for patients undergoing PCI.Trial Registration clinicaltrials. gov Identifier: NCT00093158.