Dabbous O H, Anderson F A, Gore J M, Eagle K A, Fox K A A, Mehta R H, Goldberg R J, Agnelli G, Steg P G
Center for Outcomes Research, University of Massachusetts Medical School, 365 Plantation Street, Suite 185, Worcester, MA 01605, USA.
Heart. 2008 Feb;94(2):159-65. doi: 10.1136/hrt.2006.105783. Epub 2007 Jun 17.
To compare the characteristics, management, and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) who would have been eligible for inclusion in clinical trials of glycoprotein (GP) IIb/IIIa inhibitors with those of ineligible patients.
Multinational, prospective, observational study (GRACE, Global Registry of Acute Coronary Events).
Patients hospitalised for a suspected acute coronary syndrome and enrolled in GRACE between April 1999 and December 2004.
29 039 patients with NSTE ACS.
Characteristics and outcomes were compared for trial-eligible (75.0%) and trial-ineligible (25.0%) patients.
GP IIb/IIIa inhibitors were administered to 20.0% of eligible and 15.3% of ineligible patients. Compared with eligible patients, ineligible patients who received GP IIb/IIIa inhibitors had significantly higher rates of hospital death (6.8% vs 3.7%) and major bleeding (4.9% vs 2.2%). After adjustment for their higher baseline risk, ineligible patients still experienced higher hospital death rates (adjusted odds ratio (OR) 1.60; 95% confidence interval (CI) 1.01 to 2.39), but not higher bleeding rates, than the eligible group. Use of GP IIb/IIIa inhibitors was associated with a trend towards lower 6-month mortality in eligible (OR 0.86, 95% CI 0.72 to 1.02) and ineligible (OR 0.82, 95% CI 0.65 to 1.05) patients compared with those in whom this therapy was not used.
GP IIb/IIIa inhibitors were markedly underused in the real-world population, irrespective of whether patients were trial-eligible or not. Despite the higher risk of ineligible patients, the benefits of GP IIb/IIIa inhibitors appear to be no less than in eligible patients.
比较符合糖蛋白（GP）IIb/IIIa抑制剂临床试验纳入标准的非ST段抬高型急性冠脉综合征（NSTE ACS）患者与不符合标准患者的特征、治疗及预后情况。
多中心、前瞻性观察性研究（全球急性冠脉事件注册研究，GRACE）。
1999年4月至2004年12月期间因疑似急性冠脉综合征住院并纳入GRACE的患者。
29039例NSTE ACS患者。
比较符合试验标准（75.0%）和不符合试验标准（25.0%）患者的特征及预后。
20.0%的符合标准患者和15.3%的不符合标准患者接受了GP IIb/IIIa抑制剂治疗。与符合标准的患者相比，接受GP IIb/IIIa抑制剂治疗的不符合标准患者的院内死亡率（6.8%对3.7%）和大出血发生率（4.9%对2.2%）显著更高。在对其较高的基线风险进行调整后，不符合标准的患者仍比符合标准的患者有更高的院内死亡率（调整后的优势比（OR）为1.60；95%置信区间（CI）为1.01至2.39），但出血率并未更高。与未使用该疗法的患者相比，使用GP IIb/IIIa抑制剂的符合标准患者（OR为0.86，95%CI为0.72至1.02）和不符合标准患者（OR为0.82，95%CI为0.65至1.05）6个月死亡率有降低趋势。
在现实人群中，GP IIb/IIIa抑制剂的使用明显不足，无论患者是否符合试验标准。尽管不符合标准的患者风险较高，但GP IIb/IIIa抑制剂的益处似乎并不低于符合标准的患者。
