Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial
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Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial : Dual anticoagulant/antiplatelet regimen vs antiplatelet therapy alone. / Berkowitz, Scott D; Bauersachs, Rupert M; Szarek, Michael; Nehler, Mark R; Debus, E Sebastian; Patel, Manesh R; Anand, Sonia S; Capell, Warren H; Hess, Connie N; Hsia, Judy; Leeper, Nicholas J; Brasil, David; Mátyás, Lajos; Diaz, Rafael; Brodmann, Marianne; Muehlhofer, Eva; Haskell, Lloyd P; Bonaca, Marc P.
in: J THROMB HAEMOST, Jahrgang 20, Nr. 5, 05.2022, S. 1193-1205.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial
T2 - Dual anticoagulant/antiplatelet regimen vs antiplatelet therapy alone
AU - Berkowitz, Scott D
AU - Bauersachs, Rupert M
AU - Szarek, Michael
AU - Nehler, Mark R
AU - Debus, E Sebastian
AU - Patel, Manesh R
AU - Anand, Sonia S
AU - Capell, Warren H
AU - Hess, Connie N
AU - Hsia, Judy
AU - Leeper, Nicholas J
AU - Brasil, David
AU - Mátyás, Lajos
AU - Diaz, Rafael
AU - Brodmann, Marianne
AU - Muehlhofer, Eva
AU - Haskell, Lloyd P
AU - Bonaca, Marc P
N1 - © 2022 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.
PY - 2022/5
Y1 - 2022/5
N2 - BACKGROUND: Vascular disease burden after lower extremity revascularization (LER) comprises more than the first event, more vascular beds than the local arteries, and more than one clinical event type.OBJECTIVES: Assess total arterial and venous thrombotic burden after LER for symptomatic peripheral artery disease (PAD) and effect of low-dose anticoagulation added to low-dose antiplatelet therapy.PATIENTS/METHODS: VOYAGER PAD randomized 6564 symptomatic PAD patients undergoing LER to rivaroxaban 2.5 mg twice-daily or placebo on aspirin background. Marginal proportional-hazards models used to generate treatment hazard ratios and associated 95% CIs for first and total events; non-thrombotic deaths treated as competing terminal events. Incidence rates calculated as number of events per 100 patient-years follow-up.RESULTS: Over 2.5 years (median), first and total thrombotic event rates: 7.1 and 10.3 events/100 patient-years, respectively, in placebo group. Two-thirds (925/1372) of total thrombotic events (arterial 95%, venous 5%) were nonfatal first events. Nearly one-third of patients with first event had a second arterial or venous thrombotic event. Rivaroxaban plus aspirin reduced first and total arterial and venous thrombotic events to 5.4 and 7.9 events/100 patient-years, respectively, a reduction in total thrombotic events over aspirin of 23% (HR: 0.77, 95%CI: 0.67-0.89, p = .0005), preventing 6.1 total arterial and venous thrombotic events at 3 years.CONCLUSIONS: Assessing total arterial and venous thrombotic events, not just first events, provides more complete information about disease burden and absolute on-treatment impact. Following LER, judicious modulation of more than one coagulation pathway can provide broader benefit than intensifying inhibition of one hemostatic system component.
AB - BACKGROUND: Vascular disease burden after lower extremity revascularization (LER) comprises more than the first event, more vascular beds than the local arteries, and more than one clinical event type.OBJECTIVES: Assess total arterial and venous thrombotic burden after LER for symptomatic peripheral artery disease (PAD) and effect of low-dose anticoagulation added to low-dose antiplatelet therapy.PATIENTS/METHODS: VOYAGER PAD randomized 6564 symptomatic PAD patients undergoing LER to rivaroxaban 2.5 mg twice-daily or placebo on aspirin background. Marginal proportional-hazards models used to generate treatment hazard ratios and associated 95% CIs for first and total events; non-thrombotic deaths treated as competing terminal events. Incidence rates calculated as number of events per 100 patient-years follow-up.RESULTS: Over 2.5 years (median), first and total thrombotic event rates: 7.1 and 10.3 events/100 patient-years, respectively, in placebo group. Two-thirds (925/1372) of total thrombotic events (arterial 95%, venous 5%) were nonfatal first events. Nearly one-third of patients with first event had a second arterial or venous thrombotic event. Rivaroxaban plus aspirin reduced first and total arterial and venous thrombotic events to 5.4 and 7.9 events/100 patient-years, respectively, a reduction in total thrombotic events over aspirin of 23% (HR: 0.77, 95%CI: 0.67-0.89, p = .0005), preventing 6.1 total arterial and venous thrombotic events at 3 years.CONCLUSIONS: Assessing total arterial and venous thrombotic events, not just first events, provides more complete information about disease burden and absolute on-treatment impact. Following LER, judicious modulation of more than one coagulation pathway can provide broader benefit than intensifying inhibition of one hemostatic system component.
KW - Anticoagulants/therapeutic use
KW - Arteries
KW - Aspirin/therapeutic use
KW - Endovascular Procedures/adverse effects
KW - Humans
KW - Lower Extremity/blood supply
KW - Peripheral Arterial Disease/drug therapy
KW - Platelet Aggregation Inhibitors/therapeutic use
KW - Rivaroxaban
KW - Thrombosis/etiology
U2 - 10.1111/jth.15673
DO - 10.1111/jth.15673
M3 - SCORING: Journal article
C2 - 35170216
VL - 20
SP - 1193
EP - 1205
JO - J THROMB HAEMOST
JF - J THROMB HAEMOST
SN - 1538-7933
IS - 5
ER -