Is the combination of antithrombotics and low-

dose anticoagulants worthwhile in PAD –

The VOYAGER trial

Thomas HW Stadlbauer

Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar,

Technical University of Munich

Department of Vascular and Endovascular Surgery

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Disclosure

Speaker name: Thomas Stadlbauer

I have the following potential conflicts of interest to report:

Study-Investigator: Bayer

Lecturer: Bayer, Daiichi Sankyo, Bristol Myer Squibb,

Pfizer

Travel grant: Bristol Myers Squibb, Pfizer, Daiichi Sankyo

Department of Vascular and Endovascular Surgery

• TIMI 51 in ACS

• COMPASS in stable CHD and/or PAD

There is merging evidence for the combination of

antithrombotics and low-dose anticoagulants to reduce

MACE and MALE rates in patients with cardiovascular

disease

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: TIMI 51

> 90% DAPT

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: TIMI 51

RRR 20%

for MACE

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: TIMI 51

Riva Placebo

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: COMPASS (stable CHD / PAD)

Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-

6736(17)32409-1

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: COMPASS (PAD)

Rivaroxaban 2 x 2.5 mg Rivaroxaban 2 x 5 mg

+

Aspirin 100 mg Aspirin 100 mg

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: COMPASS

MACE

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: COMPASS

MALE

Major Bleeding

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: VOAYGER-PAD

• 6,500 patients with symptomatic PAD after endovascular or surgical

revascularization procedure at the lower limb

• 1:1 randomization to rivaroxaban or matching placebo

Study population

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: VOAYGER-PAD

• 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)

Study design

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

Study design

Department of Vascular and Endovascular Surgery

Primary Efficacy Objective

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

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

Department of Vascular and Endovascular Surgery

Primary Safety Objective

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

To evaluate the overall safety and tolerability of rivaroxaban

added to ASA compared to ASA alone.

Primary Safety Variable:

➢ Major bleeding events according to the Thrombolysis in

Myocardial Infarction (TIMI) classification.

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

12/2017:

64xx

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

Department of Vascular and Endovascular Surgery

Combination of antithrombotics and low-dose

anticoagulants: Voyager-PAD

Safety

Department of Vascular and Endovascular Surgery

• Ongoing event-driven, multicenter, double-blind, randomized, placebo-

controlled 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

Take Home Messages: VOYAGER-PAD

NN

Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar,

Technical University of Munich