Is the combination of antithrombotics and lowdose anticoagulants worthwhile in PAD The VOYAGER trial

Is the combination of antithrombotics and lowdose anticoagulants worthwhile in PAD The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich

Disclosure Speaker name: Thomas Stadlbauer I have the following potential conflicts of interest to report: Study-Investigator: Lecturer: Travel grant: Bayer Bayer, Daiichi Sankyo, Bristol Myer Squibb, Pfizer Bristol Myers Squibb, Pfizer, Daiichi Sankyo xxx

There is merging evidence for the combination of antithrombotics and low-dose anticoagulants to reduce MACE and MALE rates in patients with cardiovascular disease TIMI 51 in ACS COMPASS in stable CHD and/or PAD

anticoagulants

anticoagulants: TIMI 51 > 90% DAPT

anticoagulants: TIMI 51 RRR 20% for MACE

anticoagulants: TIMI 51 Riva Placebo

anticoagulants: COMPASS (stable CHD / PAD) Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1

anticoagulants: COMPASS (PAD) Rivaroxaban 2 x 2.5 mg + Aspirin 100 mg Rivaroxaban 2 x 5 mg Aspirin 100 mg

anticoagulants: COMPASS MACE

anticoagulants: COMPASS MALE Major Bleeding

anticoagulants: VOAYGER-PAD Study population 6,500 patients with symptomatic PAD after endovascular or surgical revascularization procedure at the lower limb 1:1 randomization to rivaroxaban or matching placebo

anticoagulants: VOAYGER-PAD Study design International, multicenter Randomized, placebo-controlled, double-blind Phase 3 Event-driven (1015 positively adjudicated endpoint events) Primary efficacy analyses based on intent-to-treat (ITT) population All patients will receive ASA therapy (unblinded, 100 mg ASA daily)

anticoagulants: Voyager-PAD Study design

anticoagulants: Voyager-PAD Primary Efficacy Objective To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of major thrombotic vascular events in symptomatic PAD patients undergoing lower extremity revascularization procedure: Myocardial infarction (MI) Ischemic stroke Cardiovascular (CV) death Acute limb ischemia (ALI) Major amputation of a vascular etiology

anticoagulants: Voyager-PAD Primary Safety Objective To evaluate the overall safety and tolerability of rivaroxaban added to ASAcompared to ASA alone. Primary Safety Variable: Major bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) classification.

anticoagulants: Voyager-PAD 12/2017: 64xx

anticoagulants: Voyager-PAD

anticoagulants: Voyager-PAD

anticoagulants: Voyager-PAD Safety

Take Home Messages: VOYAGER-PAD Ongoing event-driven, multicenter, double-blind, randomized, placebocontrolled trial comparing Aspirin alone with low-dose Rivaroxaban and Aspirin in symptomatic PAD patients undergoing surgical or endovascular revascularization Endpoints: MACE + MALE + Bleeding Recruitment almost completed (64xx of 6500 patients) Up to know: 1/3 surgical revascularization 2/3 endovascular revascularization

NN Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich