Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial.
Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial.
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DOI：
10.1177/1526602818760488
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发表时间：
2018-04
期刊：
影响因子：
--
通讯作者：
ePAD Investigators
中科院分区：
文献类型：
--
作者：
Moll F;Baumgartner I;Jaff M;Nwachuku C;Tangelder M;Ansel G;Adams G;Zeller T;Rundback J;Grosso M;Lin M;Mercur MF;Minar E;ePAD Investigators
目的：报道一项针对动脉血栓主要成分的口服抗凝剂依多沙班预防血管内治疗(EVT)后再通的安全性(大出血风险)和潜在疗效的随机研究。方法：自2012年2月至2014年6月，203例股骨干静脉曲张患者随机接受阿司匹林+依多沙班或阿司匹林+氯吡格雷治疗3个月，纳入Edoxaban外周动脉疾病研究(ClinicalTrials.gov编号NCT01802775)。随机将101名患者(平均年龄68.0±10.4岁；67名男性)分为依多沙班组和102名患者(平均年龄66.7±8.6岁；78名男性)。主要安全终点是出血，根据TIMI(心肌梗死血栓溶解)标准和ISTH(国际血栓和止血学会)标准分类；有效终点是再狭窄/再闭塞率。结果：依多沙班组未发生重大或危及生命的出血事件，而按TIMI标准，氯吡格雷组有2例重大出血事件和2例危及生命的出血事件。根据ISTH分类，发生1起重大和1起危及生命的出血事件，而发生5起重大和2起危及生命的出血事件[相对危险度(RR)0.20，95%可信区间(CI)0.02~1.70]。使用TIMI或ISTH评估出血风险时，两种治疗方法的出血风险在统计学上没有差异。观察6个月后，依多沙班组再狭窄/再闭塞发生率低于氯吡格雷组(30.9%比34.7%；RR0.89，95%CI0.59比1.34，P=0.643)。结论：这些结果表明，与氯吡格雷和阿司匹林相比，接受EVT的患者使用依多沙班和阿司匹林发生重大和危及生命的出血事件的风险相似。再狭窄/再闭塞事件的发生率，虽然在统计学上没有差异，但依多沙班和阿司匹林的发生率较低，但需要足够大的试验来证实这些发现。
Purpose: To report a randomized study that investigated the safety (risk of major bleeds) and potential efficacy of edoxaban, an oral anticoagulant that targets the major components of arterial thrombi, to prevent loss of patency following endovascular treatment (EVT). Methods: Between February 2012 and June 2014, 203 patients who underwent femoropopliteal EVT were randomized to receive aspirin plus edoxaban or aspirin plus clopidogrel for 3 months in the Edoxaban in Peripheral Arterial Disease (ePAD) study (ClinicalTrials.gov identifier NCT01802775). Randomization assigned 101 patients (mean age 68.0±10.4 years; 67 men) to the edoxaban group and 102 patients (mean age 66.7±8.6 years; 78 men) to the clopidogrel group. The primary safety endpoint was bleeding as classified by the TIMI (Thrombolysis in Myocardial Infarction) criteria and ISTH (International Society of Thrombosis and Hemostasis) criteria; the efficacy endpoint was the rate of restenosis/reocclusion. Results: There were no major or life-threatening bleeding events in the edoxaban group, while there were 2 major and 2 life-threatening bleeding events in the clopidogrel group by the TIMI criteria. By the ISTH classification, there was 1 major and 1 life-threatening bleeding event vs 5 major and 2 life-threatening bleeding events, respectively [relative risk (RR) 0.20, 95% confidence interval (CI) 0.02 to 1.70]. The bleeding risk was not statistically different with either treatment when assessed by TIMI or ISTH. Following 6 months of observation, there was a lower incidence of restenosis/reocclusion with edoxaban compared with clopidogrel (30.9% vs 34.7%; RR 0.89, 95% CI 0.59 to 1.34, p=0.643). Conclusion: These results suggest that patients who have undergone EVT have similar risks for major and life-threatening bleeding events with edoxaban and aspirin compared with clopidogrel and aspirin. The incidence of restenosis/reocclusion events, while not statistically different, was lower with edoxaban and aspirin, but an adequately sized trial will be needed to confirm these findings.
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影响因子：
4.8
作者：
Chin, Chee Tang;Roe, Matthew T.;Ohman, E. Magnus
通讯作者：
Ohman, E. Magnus
DOI：
10.1161/hq0701.093520
发表时间：
2001-07-01
期刊：
Arteriosclerosis, thrombosis, and vascular biology
影响因子：
--
作者：
Hirsh, J;Anand, S S;Fuster, V
通讯作者：
Fuster, V
影响因子：
37.8
作者：
Kearney, M;Pieczek, A;Isner, JM
通讯作者：
Isner, JM
影响因子：
4.3
作者：
Koppensteiner, Renate;Spring, Silviana;van der Loo, Bemd
通讯作者：
van der Loo, Bemd
影响因子：
158.5
作者：
Schillinger, M;Sabeti, S;Minar, E
通讯作者：
Minar, E