Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Am Heart J. 2013 Sep;166(3):466-73. doi: 10.1016/j.ahj.2013.05.019. Epub 2013 Jul 25.
In the EARLY ACS trial, routine early eptifibatide was not superior to delayed provisional use at percutaneous coronary intervention (PCI); however, among PCI-treated patients, numerically fewer ischemic end points occurred in the upstream eptifibatide group. We sought to further explore this finding using methods for examination of treatment effect in this postrandomization subgroup.
Of 9,406 patients in the EARLY ACS primary analysis cohort, 9,166 (97.4%) underwent coronary angiography. We used Cox proportional hazards regression modeling, with PCI as a time-dependent covariate, to examine the effect of routine early versus delayed provisional eptifibatide among 5,541 patients undergoing PCI and to explore the interaction between treatment with PCI and randomized treatment strategy. After multivariable adjustment, compared with delayed provisional use, routine early eptifibatide was associated with lower rate of 30-day death or myocardial infarction (MI) after PCI (hazard ratio [HR] 0.80, 95% CI 0.68-0.95) but not with medical management (HR 0.97, 95% CI 0.74-1.29); PCI × randomized treatment interaction term P = .24. Excluding PCI-related MI, the adjusted HR for 30-day death or MI for routine early eptifibatide versus delayed provisional use was 0.80 (95% CI 0.60-1.08) for post-PCI treatment and 1.01 (95% CI 0.79-1.34) for medical management; PCI × randomized treatment interaction term P = .28.
Consistent with previous literature, upstream treatment with eptifibatide was associated with improved outcomes in high-risk non-ST-segment elevation acute coronary syndrome patients treated with PCI; however, a nonsignificant interaction term precludes a definite conclusion.
在 EARLY ACS 试验中,常规早期依替巴肽与经皮冠状动脉介入治疗(PCI)时的延迟性临时使用相比并无优势;然而,在接受 PCI 治疗的患者中,上游依替巴肽组的缺血终点事件数量较少。我们试图使用该随机分组亚组中治疗效果评估方法进一步探讨这一发现。
在 EARLY ACS 主要分析队列的 9406 例患者中,9166 例(97.4%)接受了冠状动脉造影。我们使用 Cox 比例风险回归模型,将 PCI 作为一个时变协变量,来检验 5541 例行 PCI 治疗的患者中常规早期与延迟性临时依替巴肽的治疗效果,并探讨治疗与随机治疗策略之间的相互作用。经过多变量调整后,与延迟性临时使用相比,常规早期依替巴肽与 PCI 后 30 天的死亡或心肌梗死(MI)发生率降低相关(风险比 [HR]0.80,95%置信区间 [CI]0.68-0.95),但与药物治疗无关(HR 0.97,95%CI0.74-1.29);PCI×随机治疗交互作用 P =.24。排除与 PCI 相关的 MI 后,常规早期依替巴肽与延迟性临时使用相比,30 天的死亡或 MI 的调整 HR 分别为 0.80(95%CI0.60-1.08)和 1.01(95%CI0.79-1.34)。PCI×随机治疗交互作用 P =.28。
与既往文献一致,在接受 PCI 治疗的高危非 ST 段抬高急性冠状动脉综合征患者中,上游依替巴肽治疗与改善预后相关;然而,无统计学意义的交互作用项无法得出明确结论。