Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer...
Transcript of Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer...
![Page 1: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/1.jpg)
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
![Page 2: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/2.jpg)
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
![Page 3: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/3.jpg)
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
![Page 4: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/4.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants
![Page 5: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/5.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: TIMI 51
> 90% DAPT
![Page 6: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/6.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: TIMI 51
RRR 20%
for MACE
![Page 7: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/7.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: TIMI 51
Riva Placebo
![Page 8: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/8.jpg)
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
![Page 9: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/9.jpg)
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
![Page 10: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/10.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: COMPASS
MACE
![Page 11: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/11.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: COMPASS
MALE
Major Bleeding
![Page 12: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/12.jpg)
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
![Page 13: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/13.jpg)
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
![Page 14: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/14.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: Voyager-PAD
Study design
![Page 15: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/15.jpg)
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
![Page 16: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/16.jpg)
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.
![Page 17: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/17.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: Voyager-PAD
12/2017:
64xx
![Page 18: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/18.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: Voyager-PAD
![Page 19: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/19.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: Voyager-PAD
![Page 20: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/20.jpg)
Department of Vascular and Endovascular Surgery
Combination of antithrombotics and low-dose
anticoagulants: Voyager-PAD
Safety
![Page 21: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/21.jpg)
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
![Page 22: Is the combination of antithrombotics and low- dose ... · The VOYAGER trial Thomas HW Stadlbauer Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical](https://reader033.fdocuments.us/reader033/viewer/2022053017/5f1c1e1686caac55ae084541/html5/thumbnails/22.jpg)
NN
Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar,
Technical University of Munich