Editor's Choice - External Applicability of the COMPASS and VOYAGER-PAD Trials on Patients with Symptomatic Lower Extremity Artery Disease in France: The COPART Registry
- PMID: 34330647
- DOI: 10.1016/j.ejvs.2021.05.028
Editor's Choice - External Applicability of the COMPASS and VOYAGER-PAD Trials on Patients with Symptomatic Lower Extremity Artery Disease in France: The COPART Registry
Abstract
Objective: The aim of this study was to examine the external applicability of the COMPASS and the VOYAGER-PAD trials in patients with lower extremity artery disease (LEAD) in the real world.
Methods: This was a multicentre retrospective analysis of prospectively collected COPART data, a French multicentre registry of patients hospitalised for symptomatic LEAD. The proportion of patients eligible for the combination of rivaroxaban 2.5 mg twice daily plus aspirin based on either COMPASS or VOYAGER-PAD criteria is reported. The one year cumulative incidence of outcomes between eligible and non-eligible patients, as well as eligible patients vs. control arms of the COMPASS (LEAD patient subgroup) and the VOYAGER-PAD trials were compared. Analyses were performed using Cox models.
Results: Of 2 259 evaluable patients, only 679 (30.1%) were eligible for a low dose rivaroxaban plus aspirin regimen. Others were not eligible because of the need for anticoagulant (48.5% and 38.9% of patients meeting COMPASS and VOYAGER-PAD exclusion criteria, respectively) or dual antiplatelet therapy use (15.7% and 16.5%, respectively), high bleeding risk (14.4% and 11.6%, respectively), malignancy (26.1% and 21.0%, respectively), history of ischaemic/haemorrhagic stroke (21.1% and 19.8%, respectively), and severe renal failure (13.2% and 10.5%, respectively). COMPASS and VOYAGER-PAD eligible and ineligible patients were at higher risk of ischaemic events than participants in these trials. The one year cumulative incidences were 6.0% (95% CI 4.3 - 8.1) in the COMPASS eligible subset vs. 3.5% (95% CI 2.9 - 4.3) in the COMPASS control arm for major adverse cardiovascular events, and 27.9% (95% CI 19.9 - 38.3) in the VOYAGER-PAD eligible subset vs. 6.0% (95% CI 5.3 - 6.9) in the VOYAGER-PAD control arm for major adverse limb events.
Conclusion: Many patients hospitalised for symptomatic LEAD in France are not eligible for the low dose rivaroxaban plus aspirin combination. In turn, those eligible may potentially have greater absolute benefit because of higher risk than those enrolled in the trials.
Keywords: Amputation; Cohort studies; Mortality; Peripheral artery disease; Rivaroxaban.
Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
Similar articles
-
Editor's Choice - Revascularisation for Peripheral Artery Disease in France: Implications for the Implementation of VOYAGER-PAD.Eur J Vasc Endovasc Surg. 2024 Jun;67(6):969-978. doi: 10.1016/j.ejvs.2024.01.091. Epub 2024 Feb 3. Eur J Vasc Endovasc Surg. 2024. PMID: 38316351
-
Revascularisation for Symptomatic Peripheral Artery Disease: External Applicability of the VOYAGER PAD Trial.Eur J Vasc Endovasc Surg. 2022 Feb;63(2):285-294. doi: 10.1016/j.ejvs.2021.10.026. Epub 2021 Dec 16. Eur J Vasc Endovasc Surg. 2022. PMID: 34924303
-
Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial.JAMA Cardiol. 2021 Jan 1;6(1):21-29. doi: 10.1001/jamacardio.2020.4390. JAMA Cardiol. 2021. PMID: 32997098 Free PMC article. Clinical Trial.
-
COMPASS for Vascular Surgeons: Practical Considerations.Curr Opin Cardiol. 2019 Mar;34(2):178-184. doi: 10.1097/HCO.0000000000000597. Curr Opin Cardiol. 2019. PMID: 30543542 Review.
-
Antithrombotic Therapy in Patients with Peripheral Artery Disease: A Focused Review on Oral Anticoagulation.Int J Mol Sci. 2021 Jul 1;22(13):7113. doi: 10.3390/ijms22137113. Int J Mol Sci. 2021. PMID: 34281167 Free PMC article. Review.
Cited by
-
Oral factor Xa inhibitor underutilization following lower extremity peripheral vascular intervention.J Vasc Surg. 2023 Aug;78(2):498-505.e1. doi: 10.1016/j.jvs.2023.04.026. Epub 2023 Apr 24. J Vasc Surg. 2023. PMID: 37100234 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical