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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

Standard

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, Vol. 20, No. 5, 05.2022, p. 1193-1205.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Berkowitz, SD, Bauersachs, RM, Szarek, M, Nehler, MR, Debus, ES, Patel, MR, Anand, SS, Capell, WH, Hess, CN, Hsia, J, Leeper, NJ, Brasil, D, Mátyás, L, Diaz, R, Brodmann, M, Muehlhofer, E, Haskell, LP & Bonaca, MP 2022, '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', J THROMB HAEMOST, vol. 20, no. 5, pp. 1193-1205. https://doi.org/10.1111/jth.15673

APA

Berkowitz, S. D., Bauersachs, R. M., Szarek, M., Nehler, M. R., Debus, E. S., Patel, M. R., Anand, S. S., Capell, W. H., Hess, C. N., Hsia, J., Leeper, N. J., Brasil, D., Mátyás, L., Diaz, R., Brodmann, M., Muehlhofer, E., Haskell, L. P., & Bonaca, M. P. (2022). 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. J THROMB HAEMOST, 20(5), 1193-1205. https://doi.org/10.1111/jth.15673

Vancouver

Berkowitz SD, Bauersachs RM, Szarek M, Nehler MR, Debus ES, Patel MR et al. 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. J THROMB HAEMOST. 2022 May;20(5):1193-1205. https://doi.org/10.1111/jth.15673

Bibtex

@article{1e245ce6963249e8a1f83e6d831cca58,
title = "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",
abstract = "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.",
keywords = "Anticoagulants/therapeutic use, Arteries, Aspirin/therapeutic use, Endovascular Procedures/adverse effects, Humans, Lower Extremity/blood supply, Peripheral Arterial Disease/drug therapy, Platelet Aggregation Inhibitors/therapeutic use, Rivaroxaban, Thrombosis/etiology",
author = "Berkowitz, {Scott D} and Bauersachs, {Rupert M} and Michael Szarek and Nehler, {Mark R} and Debus, {E Sebastian} and Patel, {Manesh R} and Anand, {Sonia S} and Capell, {Warren H} and Hess, {Connie N} and Judy Hsia and Leeper, {Nicholas J} and David Brasil and Lajos M{\'a}ty{\'a}s and Rafael Diaz and Marianne Brodmann and Eva Muehlhofer and Haskell, {Lloyd P} and Bonaca, {Marc P}",
note = "{\textcopyright} 2022 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.",
year = "2022",
month = may,
doi = "10.1111/jth.15673",
language = "English",
volume = "20",
pages = "1193--1205",
journal = "J THROMB HAEMOST",
issn = "1538-7933",
publisher = "Wiley-Blackwell",
number = "5",

}

RIS

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 -