Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial.

Moll, Frans; Baumgartner, Iris; Jaff, Michael; Nwachuku, Chuke; Tangelder, Marco; Ansel, Gary; Adams, George; Zeller, Thomas; Rundback, John; Grosso, Michael; Lin, Min; Mercur, Michele F; Minar, Erich (2018). Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial. Journal of endovascular therapy, 25(2), pp. 158-168. International Society of Endovascular Specialists 10.1177/1526602818760488

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Baumgartner, Iris

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1526-6028

Publisher:

International Society of Endovascular Specialists

Language:

English

Submitter:

Catherine Gut

Date Deposited:

11 Feb 2019 17:57

Last Modified:

11 Feb 2019 18:05

Publisher DOI:

10.1177/1526602818760488

PubMed ID:

29552984

Uncontrolled Keywords:

antiplatelet therapy aspirin bleeding clopidogrel edoxaban endovascular treatment femoropopliteal segment patency peripheral artery disease reocclusion restenosis

BORIS DOI:

10.7892/boris.123388

URI:

https://boris.unibe.ch/id/eprint/123388

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