1 Departments of Medicine and Surgery, New York University School of Medicine, New York, NY, USA.
2 University of Toronto, Toronto, ON, Canada.
Vasc Med. 2018 Dec;23(6):523-530. doi: 10.1177/1358863X18775594. Epub 2018 Jul 11.
Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular morbidity and mortality. We sought to evaluate the risk of concomitant coronary artery disease (CAD) in patients with symptomatic PAD versus PAD without diagnosed CAD, and whether ticagrelor was superior to clopidogrel in reducing that risk. The EUCLID trial randomized 13,885 patients with PAD to antithrombotic monotherapy with ticagrelor or clopidogrel. CAD was defined as prior myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) surgery. Median follow-up was 30 months. Among 4032 (29%) patients with PAD and CAD, 63% had prior MI, 54% prior PCI, and 38% prior CABG. After adjustment for baseline characteristics, patients with PAD and CAD had significantly higher rates of the primary endpoint (cardiovascular death/MI/stroke, 15.3% vs 8.9%, hazard ratio (HR) 1.50, 95% CI: 1.13-1.99; p=0.005), but no statistically significant increase in acute limb ischemia (HR 1.28, 95% CI: 0.57-2.85; p=0.55) or major bleeding (HR 1.10, 95% CI: 0.49-2.48; p=0.81) versus PAD without CAD. Among patients with PAD and CAD, there was no differential treatment effect between ticagrelor versus clopidogrel for the primary efficacy endpoint (HR 1.02, 95% CI: 0.87-1.19; p=0.84), acute limb ischemia (HR 1.03, 95% CI: 0.63-1.69; p=0.89), or major bleeding (HR 1.06, 95% CI: 0.66-1.69; p=0.81). There was a statistically significant interaction between prior coronary stent placement and study treatment ( p=0.03) with a numerical reduction in the primary efficacy endpoint with ticagrelor versus clopidogrel (13.8% vs 16.8%, HR 0.82, 95% CI: 0.65-1.03; p=0.09). Patients with PAD and prior CAD had higher composite rates of cardiovascular death, MI, and ischemic stroke versus PAD without diagnosed CAD. There were no significant differences between ticagrelor and clopidogrel in cardiovascular events or major bleeding. ClinicalTrials.gov Identifier: NCT01732822.
患有外周动脉疾病（PAD）的患者心血管发病率和死亡率较高。我们旨在评估有症状 PAD 患者与无诊断 CAD 的 PAD 患者同时发生冠状动脉疾病（CAD）的风险，以及替格瑞洛是否优于氯吡格雷降低该风险。EUCLID 试验将 13885 名 PAD 患者随机分配至替格瑞洛或氯吡格雷的抗血栓单药治疗。CAD 定义为既往心肌梗死（MI）、经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG）。中位随访时间为 30 个月。在 4032 名（29%）有 CAD 和 PAD 的患者中，63%有既往 MI，54%有既往 PCI，38%有既往 CABG。在调整基线特征后，有 CAD 和 PAD 的患者主要终点（心血管死亡/MI/中风）发生率显著更高（15.3% vs 8.9%，风险比[HR]1.50，95%置信区间：1.13-1.99；p=0.005），但急性肢体缺血（HR 1.28，95%置信区间：0.57-2.85；p=0.55）或大出血（HR 1.10，95%置信区间：0.49-2.48；p=0.81）无统计学显著增加与无 CAD 的 PAD 相比。在有 CAD 和 PAD 的患者中，替格瑞洛与氯吡格雷在主要疗效终点（HR 1.02，95%置信区间：0.87-1.19；p=0.84）、急性肢体缺血（HR 1.03，95%置信区间：0.63-1.69；p=0.89）或大出血（HR 1.06，95%置信区间：0.66-1.69；p=0.81）方面无差异治疗效果。既往冠状动脉支架置入与研究治疗之间存在统计学显著交互作用（p=0.03），替格瑞洛与氯吡格雷相比，主要疗效终点有数值减少（13.8% vs 16.8%，HR 0.82，95%置信区间：0.65-1.03；p=0.09）。有既往 CAD 的 PAD 患者与无诊断 CAD 的 PAD 患者相比，心血管死亡、MI 和缺血性中风的复合率更高。替格瑞洛与氯吡格雷在心血管事件或大出血方面无显著差异。临床试验.gov 标识符：NCT01732822。
