Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial
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Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. / Bauersachs, Rupert M; Szarek, Michael; Brodmann, Marianne; Gudz, Ivan; Debus, Eike Sebastian; Nehler, Mark R; Anand, Sonia S; Patel, Manesh R; Hess, Connie N; Capell, Warren H; Rogers, Kevin; Muehlhofer, Eva; Haskell, Lloyd P; Berkowitz, Scott D; Hiatt, William R; Bonaca, Marc P; VOYAGER PAD Committees and Investigators.
in: J AM COLL CARDIOL, Jahrgang 78, Nr. 4, 27.07.2021, S. 317-326.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial
AU - Bauersachs, Rupert M
AU - Szarek, Michael
AU - Brodmann, Marianne
AU - Gudz, Ivan
AU - Debus, Eike Sebastian
AU - Nehler, Mark R
AU - Anand, Sonia S
AU - Patel, Manesh R
AU - Hess, Connie N
AU - Capell, Warren H
AU - Rogers, Kevin
AU - Muehlhofer, Eva
AU - Haskell, Lloyd P
AU - Berkowitz, Scott D
AU - Hiatt, William R
AU - Bonaca, Marc P
AU - VOYAGER PAD Committees and Investigators
N1 - Copyright © 2021. Published by Elsevier Inc.
PY - 2021/7/27
Y1 - 2021/7/27
N2 - BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown.OBJECTIVES: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events.METHODS: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models.RESULTS: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) and total vascular events (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003). An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years.CONCLUSIONS: Patients with symptomatic PAD who are undergoing LER have a high total event burden that is significantly reduced with rivaroxaban. Total event reduction may be a useful metric to quantify the efficacy of rivaroxaban in this setting. (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities [VOYAGER PAD]; NCT02504216).
AB - BACKGROUND: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown.OBJECTIVES: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events.METHODS: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models.RESULTS: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) and total vascular events (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003). An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years.CONCLUSIONS: Patients with symptomatic PAD who are undergoing LER have a high total event burden that is significantly reduced with rivaroxaban. Total event reduction may be a useful metric to quantify the efficacy of rivaroxaban in this setting. (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities [VOYAGER PAD]; NCT02504216).
KW - Aged
KW - Dose-Response Relationship, Drug
KW - Drug Therapy, Combination
KW - Factor Xa Inhibitors/administration & dosage
KW - Global Health
KW - Humans
KW - Incidence
KW - Ischemia/epidemiology
KW - Lower Extremity/blood supply
KW - Male
KW - Middle Aged
KW - Peripheral Arterial Disease/complications
KW - Rivaroxaban/administration & dosage
KW - Treatment Outcome
KW - Vascular Surgical Procedures/methods
U2 - 10.1016/j.jacc.2021.05.003
DO - 10.1016/j.jacc.2021.05.003
M3 - SCORING: Journal article
C2 - 34010631
VL - 78
SP - 317
EP - 326
JO - J AM COLL CARDIOL
JF - J AM COLL CARDIOL
SN - 0735-1097
IS - 4
ER -