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Sökning: WFRF:(Debus M.) > (2023) > Rivaroxaban in Pati...

Rivaroxaban in Patients with Symptomatic Peripheral Artery Disease after Lower Extremity Bypass Surgery with Venous and Prosthetic Conduits

Govsyeyev, Nicholas (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO, USA
Nehler, Mark (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO, USA
Conte, Michael (författare)
Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA, USA
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Debus, Sebastian (författare)
Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg, Germany
Chung, Jayer (författare)
Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, TX, USA
Dorigo, Walter (författare)
Department of Vascular Surgery, Careggi Polyclinic Hospital, University of Florence, Florence, Italy
Gudz, Ivan (författare)
Surgery department of Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine
Krievins, Dainis (författare)
Pauls Stradins university hospital, University of Latvia, Riga, Latvia
Mills, Joseph (författare)
Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, TX, USA
Moll, Frans (författare)
Vascular Surgery Department, University Medical Center, Utrecht, the Netherlands
Norgren, Lars, 1942- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper
Piffaretti, Gabriele (författare)
Department of Vascular Surgery, ASST dei Sette Laghi, Varese, Italy
Powell, Rick (författare)
Section of Vascular Surgery Dartmouth Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, Lebanon and Hanover, NH, USA
Szalay, David (författare)
Division of Vascular Surgery, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada
Sillesen, Henrik (författare)
Department of Vascular Surgery, Rigshospitalet, Institute of Clinical Medicine, University of Copenhagen, Denmark
Wohlauer, Max (författare)
Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO, USA
Szarek, Michael (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA; State University of New York, Downstate Health Sciences University, Brooklyn, USA
Bauersachs, Rupert M. (författare)
Cardioangiologic Center Bethanien, Frankfurt, Germany; Center for Thrombosis and Hemostasis, University of Mainz, Mainz, Germany
Anand, Sonia S. (författare)
Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada
Patel, Manesh R. (författare)
Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC, USA
Capell, Warren H. (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Medicine, Division of Endocrinology, University of Colorado School of Medicine, Aurora, CO, USA
Jaeger, Nicole (författare)
CPC Clinical Research, Aurora, CO, USA
Hess, Connie N. (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA
Muehlhofer, Eva (författare)
Bayer AG Research and Development, Wuppertal, Germany
Haskell, Lloyd P (författare)
Janssen Research and Development, Raritan, NJ, USA
Berkowitz, Scott D. (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA; Department of Medicine, Division of Hematology, University of Colorado School of Medicine, Aurora, CO, USA
Bonaca, Marc P. (författare)
CPC Clinical Research, Aurora, CO, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA
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 (creator_code:org_t)
Elsevier, 2023
2023
Engelska.
Ingår i: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 77:4, s. 1107-1118.e2
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. VOYAGER PAD demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit in patients undergoing surgical revascularization; however, the efficacy and safety in those treated by surgical bypass including stratified by bypass conduit (venous or prosthetic) has not been described.METHODS: In the VOYAGER PAD trial, patients with PAD after surgical and endovascular infrainguinal LER were randomized to rivaroxaban 2.5 mg twice daily or placebo and followed for a median of 28 months. The primary endpoint was a composite of acute limb ischemia (ALI), major amputation of vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Index procedure details including conduit type (venous or prosthetic) were collected at baseline.RESULTS: Among 6564 randomized, 2185 (33%) underwent surgical LER. Of these, surgical bypass was performed in 1448 (66%), using prosthetic conduit in 773 (53%) and venous in 646 (45%). Adjusting for baseline differences and anatomic factors, the risk for unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving prosthetic versus venous conduits (adjHR 2.53, 95% CI 1.65-3.90; p<0.001) while the risk for ALI was 3 times greater (adjHR 3.07, 95% CI 1.84-5.11; p<0.001). Rivaroxaban reduced the primary outcome in patients treated with bypass surgery (HR 0.78, 95% CI 0.62-0.98) with consistent benefits in those receiving venous (HR 0.66, 95% CI 0.49-0.96) and prosthetic (HR 0.87, 95% CI 0.66-1.15) conduits (pinteraction 0.254). In the overall trial, TIMI major bleeding was increased with rivaroxaban; however, numbers in those treated with bypass surgery were low (5 with rivaroxaban, 9 with placebo, HR 0.55, 95% CI 0.18-1.65) and not powered to show statistical significance.CONCLUSIONS: Surgical bypass with prosthetic conduit is associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjusting for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduces this risk, increases bleeding, but has a favorable benefit risk in patients treated with bypass surgery and regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)

Nyckelord

Antithrombotic therapy
Bypass
Conduit
Multicenter
Subgroup analysis

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ref (ämneskategori)
art (ämneskategori)

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