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

Holger.Lawall@gmail.com

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