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
xxx
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
