Dr. Holger Lawall
Rationale and design of the
VOYAGER-PAD Trial
Holger Lawall, MD
Praxis für Herzkreislauferkrankungen Ettlingen
Max Grundig Klinik Bühlerhöhe
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Dr. Holger Lawall
Conflict of interests
• Steering committee of the VOYAGER study
• BAYER Vital GmbH : advisory board, honoraries for
lectures
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Dr. Holger Lawall
VOYAGER-PAD
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EudraCT : 2014-005569-58
Dr. Holger Lawall
Rationale and background
• atherosclerotic stenosis and occlusion
• atheroma, underlying chronic inflammation
• plaque rupture and arterial thrombosis
PAD CAD
1 year risk 5,4 % 4,5 %
3 year risk 14,8 % 11,6 %
Dr. Holger Lawall
Background : high risk for CV events
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In hospital mortality
Re – revascularization
MI
Stroke
Renal failure
Major amputation in CLI
Dr. Holger Lawall
Outcome of PAD and CLI – Germany 2009-2011
RF 1-3 RF 4 RF 5 RF 6 Total p
Patients, n (% of all) 21,197 (50.6) 5,353 (12.8) 6,916 (16.5) 8,416 (20.1) 41,882 (100.0)
Angiography, n (%) 12,339 (58.2) 3,128 (58.4) 3,567 (51.6) 4,032 (47.9) 23,066 (55.1) < 0.001
Endovascular, n (%) 11,602 (54.7) 2,043 (38.2) 2,450 (35.4) 2,481 (29.5) 18,576 (44.4) < 0.001
Surgery, n (%) 5,068 (23.9) 2,130 (39.8) 1,312 (19.0) 2,083 (24.8) 10,593 (25.3) < 0.001
TEA, n (%) 2,736 (12.9) 932 (17.4) 514 (7.4) 807 (9.6) 4,989 (11.9) < 0.001
Bypass, n (%) 2,068 (9.8) 1,000 (18.7) 816 (11.8) 1,326 (15.8) 5,210 (12.4) < 0.001
Any revascularization, n (%) 15,963 (75.3) 3,817 (71.3) 3,518 (50.9) 4,140 (49.2) 27,438 (65.5) < 0.001
Acute renal failure, n (%) 76 (0.4) 73 (1.4) 127 (1.8) 235 (2.8) 511 (1.2) < 0.001
MI, n (%) 68 (0.3) 44 (0.8) 58 (0.8) 147 (1.7) 317 (0.8) < 0.001
Ischemic stroke, n (%) 33 (0.2) 21 (0.4) 29 (0.4) 63 (0.7) 146 (0.3) < 0.001
Table 2: Treatment, complications and outcomes during index hospitalization
N=41822
Reinecke H et al. Eur Heart J 2015; doi 10.193/eurheartj/evh006
Mortalität Claudicatio 2,2 %
Mortalität kritische Ischämie 8,4 %
Dr. Holger Lawall
Rivaroxaban
• predictable dose response
• clinically proven anti-ischemic and anti-
thombotic effects (MI, stroke)
• prevention of stent thrombosis
• will impact both traditional coronary
outcomes and peripheral vascular events
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COMPASS – Study : Riva 5 mg bid vs Riva 2,5 mg bid +ASS vs ASS alone
with history of CAD or PAD; n = 21.000 pat.
Dr. Holger Lawall
Primary composite endpoint
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Dr. Holger Lawall
Secondary endpoint
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Re-revascularization
major amputation
MACE: MI, stroke, ALI
cardiovasc mortality
all-cause mortality
Re –hospitalisation
VTE
Dr. Holger Lawall
Inclusion criteria : symptomatic pad
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Exclusion criteria
asymptomatic or mild pad without functional limitation
asymptomatic or minimally target lesion
prior revascularization less than 8 weeks before
randomisation
planned dual antiplatelet therapy longer than 30 days
planned DAPT for any other indication
need for anticoagulation (Hep. VKA, DOAK)
GFR < 15 ml/min
ALI prior 2 weeks before randomisation
ACS 6 months before randomisation
history of bleeding 6 months before randomisation
Dr. Holger Lawall
Study design
• event – driven study
• ASS plus Placebo vs. ASS plus Rivaroxaban 2,5 mg bid
• mean treatment 30 months (- 42 m.)
• 6.500 pat.
• prim. efficacy outcome endpoint : composite endpoint of
major thrombotic vascular events : MI, stroke, ALI, major
amputation, CV death (1015 pat.)
• prespecified : use of Clopidogrel, surgical vs. endovascular
• prim safety : bleeding (major, minor, (TIMI –classif.))
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Dr. Holger Lawall
VOYAGER-PAD
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Dr. Holger Lawall 13
Dr. Holger Lawall 14
Dr. Holger Lawall
Vielen Dank für Ihre
Aufmerksamkeit
Kontakt
Dr. med. Holger Lawall
Lindenweg 1 · 76275 Ettlingen
Fon 07243 / 94 57 694
Fax 07243 / 94 57 699
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