Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin

Paolo Prandoni; Anthonie W.A. Lensing; Martin H. Prins; Martin Gebel; Akos F. Pap; Martin Homering; Rupert Bauersachs; Jan Beyer-Westendorf; Henri Bounameaux; Alexander T. Cohen; Bruce L. Davidson; Bonno van Bellen; Peter Verhamme; Philip S. Wells; Zhong Yuan; Bennett Levitan; Jeffrey I. Weitz

doi:10.1016/j.thromres.2018.06.009

Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin

Paolo Prandoni, Anthonie W.A. Lensing, Martin H. Prins, Martin Gebel, Akos F. Pap, Martin Homering, Rupert Bauersachs, Jan Beyer-Westendorf, Henri Bounameaux, Alexander T. Cohen, Bruce L. Davidson, Bonno van Bellen, Peter Verhamme, Philip S. Wells, Zhong Yuan, Bennett Levitan, Jeffrey I. Weitz

Research output: Contribution to journal › Article › peer-review

11 Citations (Scopus)

Abstract

Background
Full- or lower-dose anticoagulant therapy or aspirin can be used for extended therapy in patients with venous thromboembolism (VTE), but information on their relative benefit-risk profiles is limited.

Methods
Data from the EINSTEIN-CHOICE trial were used to compare the benefit-risk profiles of extended treatment with rivaroxaban (20 or 10 mg once daily) and aspirin (100 mg once daily) in VTE patients who had completed 6 to 12 months of anticoagulation therapy. One-year cumulative incidences of recurrent VTE and major bleeding were estimated and benefits and risks were calculated by determining the between group differences in a hypothetical population of 10,000 VTE patients treated for 1 year.

Findings
A total of 1107 patients were treated with 20 mg of rivaroxaban, 1127 with 10 mg of rivaroxaban, and 1131 with aspirin. The cumulative incidences of recurrent VTE in the rivaroxaban 20-mg, rivaroxaban 10-mg and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively, whereas the cumulative incidences of major bleeding were 0.7%, 0.4% and 0.5%, respectively. The incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups than in the aspirin group. For 10,000 patients treated for 1 year, there would be 284 (95% confidence interval [CI] 106 to 462) and 339 (95% CI 165 to 512) fewer events with rivaroxaban 20 mg or 10 mg than with aspirin.

Interpretation
Compared with aspirin, extended anticoagulation with once daily rivaroxaban reduces recurrent VTE with a favourable benefit-risk profile.

Original language	English
Pages (from-to)	121-129
Number of pages	9
Journal	Thrombosis Research
Volume	168
Early online date	10 Jul 2018
DOIs	https://doi.org/10.1016/j.thromres.2018.06.009
Publication status	Published - 2018

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10.1016/j.thromres.2018.06.009

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Prandoni, P., Lensing, A. W. A., Prins, M. H., Gebel, M., Pap, A. F., Homering, M., Bauersachs, R., Beyer-Westendorf, J., Bounameaux, H., Cohen, A. T., Davidson, B. L., van Bellen, B., Verhamme, P., Wells, P. S., Yuan, Z., Levitan, B., & Weitz, J. I. (2018). Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin. Thrombosis Research, 168, 121-129. https://doi.org/10.1016/j.thromres.2018.06.009

@article{d1e3b08cc3bc4680a479bbdd2be7c902,

title = "Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin",

abstract = "BackgroundFull- or lower-dose anticoagulant therapy or aspirin can be used for extended therapy in patients with venous thromboembolism (VTE), but information on their relative benefit-risk profiles is limited.MethodsData from the EINSTEIN-CHOICE trial were used to compare the benefit-risk profiles of extended treatment with rivaroxaban (20 or 10 mg once daily) and aspirin (100 mg once daily) in VTE patients who had completed 6 to 12 months of anticoagulation therapy. One-year cumulative incidences of recurrent VTE and major bleeding were estimated and benefits and risks were calculated by determining the between group differences in a hypothetical population of 10,000 VTE patients treated for 1 year.FindingsA total of 1107 patients were treated with 20 mg of rivaroxaban, 1127 with 10 mg of rivaroxaban, and 1131 with aspirin. The cumulative incidences of recurrent VTE in the rivaroxaban 20-mg, rivaroxaban 10-mg and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively, whereas the cumulative incidences of major bleeding were 0.7%, 0.4% and 0.5%, respectively. The incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups than in the aspirin group. For 10,000 patients treated for 1 year, there would be 284 (95% confidence interval [CI] 106 to 462) and 339 (95% CI 165 to 512) fewer events with rivaroxaban 20 mg or 10 mg than with aspirin.InterpretationCompared with aspirin, extended anticoagulation with once daily rivaroxaban reduces recurrent VTE with a favourable benefit-risk profile.",

author = "Paolo Prandoni and Lensing, {Anthonie W.A.} and Prins, {Martin H.} and Martin Gebel and Pap, {Akos F.} and Martin Homering and Rupert Bauersachs and Jan Beyer-Westendorf and Henri Bounameaux and Cohen, {Alexander T.} and Davidson, {Bruce L.} and {van Bellen}, Bonno and Peter Verhamme and Wells, {Philip S.} and Zhong Yuan and Bennett Levitan and Weitz, {Jeffrey I.}",

year = "2018",

doi = "10.1016/j.thromres.2018.06.009",

language = "English",

volume = "168",

pages = "121--129",

journal = "Thrombosis Research",

issn = "0049-3848",

publisher = "Elsevier Limited",

}

Prandoni, P, Lensing, AWA, Prins, MH, Gebel, M, Pap, AF, Homering, M, Bauersachs, R, Beyer-Westendorf, J, Bounameaux, H, Cohen, AT, Davidson, BL, van Bellen, B, Verhamme, P, Wells, PS, Yuan, Z, Levitan, B & Weitz, JI 2018, 'Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin', Thrombosis Research, vol. 168, pp. 121-129. https://doi.org/10.1016/j.thromres.2018.06.009

TY - JOUR

T1 - Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin

AU - Prandoni, Paolo

AU - Lensing, Anthonie W.A.

AU - Prins, Martin H.

AU - Gebel, Martin

AU - Pap, Akos F.

AU - Homering, Martin

AU - Bauersachs, Rupert

AU - Beyer-Westendorf, Jan

AU - Bounameaux, Henri

AU - Cohen, Alexander T.

AU - Davidson, Bruce L.

AU - van Bellen, Bonno

AU - Verhamme, Peter

AU - Wells, Philip S.

AU - Yuan, Zhong

AU - Levitan, Bennett

AU - Weitz, Jeffrey I.

PY - 2018

Y1 - 2018

N2 - BackgroundFull- or lower-dose anticoagulant therapy or aspirin can be used for extended therapy in patients with venous thromboembolism (VTE), but information on their relative benefit-risk profiles is limited.MethodsData from the EINSTEIN-CHOICE trial were used to compare the benefit-risk profiles of extended treatment with rivaroxaban (20 or 10 mg once daily) and aspirin (100 mg once daily) in VTE patients who had completed 6 to 12 months of anticoagulation therapy. One-year cumulative incidences of recurrent VTE and major bleeding were estimated and benefits and risks were calculated by determining the between group differences in a hypothetical population of 10,000 VTE patients treated for 1 year.FindingsA total of 1107 patients were treated with 20 mg of rivaroxaban, 1127 with 10 mg of rivaroxaban, and 1131 with aspirin. The cumulative incidences of recurrent VTE in the rivaroxaban 20-mg, rivaroxaban 10-mg and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively, whereas the cumulative incidences of major bleeding were 0.7%, 0.4% and 0.5%, respectively. The incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups than in the aspirin group. For 10,000 patients treated for 1 year, there would be 284 (95% confidence interval [CI] 106 to 462) and 339 (95% CI 165 to 512) fewer events with rivaroxaban 20 mg or 10 mg than with aspirin.InterpretationCompared with aspirin, extended anticoagulation with once daily rivaroxaban reduces recurrent VTE with a favourable benefit-risk profile.

AB - BackgroundFull- or lower-dose anticoagulant therapy or aspirin can be used for extended therapy in patients with venous thromboembolism (VTE), but information on their relative benefit-risk profiles is limited.MethodsData from the EINSTEIN-CHOICE trial were used to compare the benefit-risk profiles of extended treatment with rivaroxaban (20 or 10 mg once daily) and aspirin (100 mg once daily) in VTE patients who had completed 6 to 12 months of anticoagulation therapy. One-year cumulative incidences of recurrent VTE and major bleeding were estimated and benefits and risks were calculated by determining the between group differences in a hypothetical population of 10,000 VTE patients treated for 1 year.FindingsA total of 1107 patients were treated with 20 mg of rivaroxaban, 1127 with 10 mg of rivaroxaban, and 1131 with aspirin. The cumulative incidences of recurrent VTE in the rivaroxaban 20-mg, rivaroxaban 10-mg and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively, whereas the cumulative incidences of major bleeding were 0.7%, 0.4% and 0.5%, respectively. The incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups than in the aspirin group. For 10,000 patients treated for 1 year, there would be 284 (95% confidence interval [CI] 106 to 462) and 339 (95% CI 165 to 512) fewer events with rivaroxaban 20 mg or 10 mg than with aspirin.InterpretationCompared with aspirin, extended anticoagulation with once daily rivaroxaban reduces recurrent VTE with a favourable benefit-risk profile.

U2 - 10.1016/j.thromres.2018.06.009

DO - 10.1016/j.thromres.2018.06.009

M3 - Article

SN - 0049-3848

VL - 168

SP - 121

EP - 129

JO - Thrombosis Research

JF - Thrombosis Research

ER -

Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin

Abstract

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