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

Transcription

1 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

2 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

3 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

4 anticoagulants

5 anticoagulants: TIMI 51 > 90% DAPT

6 anticoagulants: TIMI 51 RRR 20% for MACE

7 anticoagulants: TIMI 51 Riva Placebo

8 anticoagulants: COMPASS (stable CHD / PAD) Lancet Nov 10. pii: S (17) doi: /S (17)

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

10 anticoagulants: COMPASS MACE

11 anticoagulants: COMPASS MALE Major Bleeding

12 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

13 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)

14 anticoagulants: Voyager-PAD Study design

15 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

16 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.

17 anticoagulants: Voyager-PAD 12/2017: 64xx

18 anticoagulants: Voyager-PAD

19 anticoagulants: Voyager-PAD

20 anticoagulants: Voyager-PAD Safety

21 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

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