Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial

John W. Eikelboom; Jacqueline Bosch; Stuart J. Connolly; Jessica Tyrwitt; Keith A.A. Fox; Eva Muehlhofer; Christoph Neumann; Christoph Tasto; Shrikant I. Bangdiwala; Rafael Diaz; Marco Alings; Gilles R. Dagenais; Darryl P. Leong; Eva M. Lonn; Alvaro Avezum; Leopoldo S. Piegas; Petr Widimsky; Alexander N. Parkhomenko; Deepak L. Bhatt; Kelley R.H. Branch; Jeffrey L. Probstfield; Patricio Lopez-Jaramillo; Lars Rydén; Nana Pogosova; Katalin Keltai; Matyas Keltai; Georg Ertl; Stefan Stoerk; Antonio L. Dans; Fernando Lanas; Yan Liang; Jun Zhu; Christian Torp-Pedersen; Aldo P. Maggioni; Patrick J. Commerford; Tomasz J. Guzik; Thomas Vanassche; Peter Verhamme; Martin O'donnell; Andrew M. Tonkin; John D. Varigos; Dragos Vinereanu; Camillo Felix; Jae Hyung Kim; Khairul S. Ibrahim; Basil S. Lewis; Kaj P. Metsarinne; Victor Aboyans; Phillippe Gabriel Steg; Masatsugu Hori; Ajay Kakkar; Sonia S. Anand; Andre Lamy; Mukul Sharma; Salim Yusuf

doi:10.1093/ehjcvp/pvac023

Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial

John W. Eikelboom, Jacqueline Bosch, Stuart J. Connolly, Jessica Tyrwitt, Keith A.A. Fox, Eva Muehlhofer, Christoph Neumann, Christoph Tasto, Shrikant I. Bangdiwala, Rafael Diaz, Marco Alings, Gilles R. Dagenais, Darryl P. Leong, Eva M. Lonn, Alvaro Avezum, Leopoldo S. Piegas, Petr Widimsky, Alexander N. Parkhomenko, Deepak L. Bhatt, Kelley R.H. BranchJeffrey L. Probstfield, Patricio Lopez-Jaramillo, Lars Rydén, Nana Pogosova, Katalin Keltai, Matyas Keltai, Georg Ertl, Stefan Stoerk, Antonio L. Dans, Fernando Lanas, Yan Liang, Jun Zhu, Christian Torp-Pedersen, Aldo P. Maggioni, Patrick J. Commerford, Tomasz J. Guzik, Thomas Vanassche, Peter Verhamme, Martin O'donnell, Andrew M. Tonkin, John D. Varigos, Dragos Vinereanu, Camillo Felix, Jae Hyung Kim, Khairul S. Ibrahim, Basil S. Lewis, Kaj P. Metsarinne, Victor Aboyans, Phillippe Gabriel Steg, Masatsugu Hori, Ajay Kakkar, Sonia S. Anand, Andre Lamy, Mukul Sharma, Salim Yusuf

Research output: Articles / Notes › Scientific Article › peer-review

14 Scopus citations

Abstract

Aims: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). Methods and results: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. Conclusion: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.

Original language	English
Pages (from-to)	786-795
Number of pages	10
Journal	European Heart Journal - Cardiovascular Pharmacotherapy
Volume	8
Issue number	8
DOIs	https://doi.org/10.1093/ehjcvp/pvac023
State	Published - 1 Dec 2022
Externally published	Yes

Keywords

Aspirin
Coronary artery disease
Peripheral artery disease
Rivaroxaban

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10.1093/ehjcvp/pvac023

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Eikelboom, J. W., Bosch, J., Connolly, S. J., Tyrwitt, J., Fox, K. A. A., Muehlhofer, E., Neumann, C., Tasto, C., Bangdiwala, S. I., Diaz, R., Alings, M., Dagenais, G. R., Leong, D. P., Lonn, E. M., Avezum, A., Piegas, L. S., Widimsky, P., Parkhomenko, A. N., Bhatt, D. L., ... Yusuf, S. (2022). Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. European Heart Journal - Cardiovascular Pharmacotherapy, 8(8), 786-795. https://doi.org/10.1093/ehjcvp/pvac023

@article{d61dff91fdf14aa9ad475d0bfb303b47,

title = "Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial",

abstract = "Aims: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). Methods and results: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. Conclusion: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.",

keywords = "Aspirin, Coronary artery disease, Peripheral artery disease, Rivaroxaban",

author = "Eikelboom, {John W.} and Jacqueline Bosch and Connolly, {Stuart J.} and Jessica Tyrwitt and Fox, {Keith A.A.} and Eva Muehlhofer and Christoph Neumann and Christoph Tasto and Bangdiwala, {Shrikant I.} and Rafael Diaz and Marco Alings and Dagenais, {Gilles R.} and Leong, {Darryl P.} and Lonn, {Eva M.} and Alvaro Avezum and Piegas, {Leopoldo S.} and Petr Widimsky and Parkhomenko, {Alexander N.} and Bhatt, {Deepak L.} and Branch, {Kelley R.H.} and Probstfield, {Jeffrey L.} and Patricio Lopez-Jaramillo and Lars Ryd{\'e}n and Nana Pogosova and Katalin Keltai and Matyas Keltai and Georg Ertl and Stefan Stoerk and Dans, {Antonio L.} and Fernando Lanas and Yan Liang and Jun Zhu and Christian Torp-Pedersen and Maggioni, {Aldo P.} and Commerford, {Patrick J.} and Guzik, {Tomasz J.} and Thomas Vanassche and Peter Verhamme and Martin O'donnell and Tonkin, {Andrew M.} and Varigos, {John D.} and Dragos Vinereanu and Camillo Felix and Kim, {Jae Hyung} and Ibrahim, {Khairul S.} and Lewis, {Basil S.} and Metsarinne, {Kaj P.} and Victor Aboyans and Steg, {Phillippe Gabriel} and Masatsugu Hori and Ajay Kakkar and Anand, {Sonia S.} and Andre Lamy and Mukul Sharma and Salim Yusuf",

note = "Publisher Copyright: {\textcopyright} 2022 The Author(s).",

year = "2022",

month = dec,

day = "1",

doi = "10.1093/ehjcvp/pvac023",

language = "Ingl{\'e}s",

volume = "8",

pages = "786--795",

journal = "European Heart Journal - Cardiovascular Pharmacotherapy",

issn = "2055-6837",

publisher = "Oxford University Press",

number = "8",

}

Eikelboom, JW, Bosch, J, Connolly, SJ, Tyrwitt, J, Fox, KAA, Muehlhofer, E, Neumann, C, Tasto, C, Bangdiwala, SI, Diaz, R, Alings, M, Dagenais, GR, Leong, DP, Lonn, EM, Avezum, A, Piegas, LS, Widimsky, P, Parkhomenko, AN, Bhatt, DL, Branch, KRH, Probstfield, JL, Lopez-Jaramillo, P, Rydén, L, Pogosova, N, Keltai, K, Keltai, M, Ertl, G, Stoerk, S, Dans, AL, Lanas, F, Liang, Y, Zhu, J, Torp-Pedersen, C, Maggioni, AP, Commerford, PJ, Guzik, TJ, Vanassche, T, Verhamme, P, O'donnell, M, Tonkin, AM, Varigos, JD, Vinereanu, D, Felix, C, Kim, JH, Ibrahim, KS, Lewis, BS, Metsarinne, KP, Aboyans, V, Steg, PG, Hori, M, Kakkar, A, Anand, SS, Lamy, A, Sharma, M & Yusuf, S 2022, 'Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial', European Heart Journal - Cardiovascular Pharmacotherapy, vol. 8, no. 8, pp. 786-795. https://doi.org/10.1093/ehjcvp/pvac023

Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. / Eikelboom, John W.; Bosch, Jacqueline; Connolly, Stuart J. et al.
In: European Heart Journal - Cardiovascular Pharmacotherapy, Vol. 8, No. 8, 01.12.2022, p. 786-795.

Research output: Articles / Notes › Scientific Article › peer-review

TY - JOUR

T1 - Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease

T2 - Outcomes During the Open Label Extension of the COMPASS trial

AU - Eikelboom, John W.

AU - Bosch, Jacqueline

AU - Connolly, Stuart J.

AU - Tyrwitt, Jessica

AU - Fox, Keith A.A.

AU - Muehlhofer, Eva

AU - Neumann, Christoph

AU - Tasto, Christoph

AU - Bangdiwala, Shrikant I.

AU - Diaz, Rafael

AU - Alings, Marco

AU - Dagenais, Gilles R.

AU - Leong, Darryl P.

AU - Lonn, Eva M.

AU - Avezum, Alvaro

AU - Piegas, Leopoldo S.

AU - Widimsky, Petr

AU - Parkhomenko, Alexander N.

AU - Bhatt, Deepak L.

AU - Branch, Kelley R.H.

AU - Probstfield, Jeffrey L.

AU - Lopez-Jaramillo, Patricio

AU - Rydén, Lars

AU - Pogosova, Nana

AU - Keltai, Katalin

AU - Keltai, Matyas

AU - Ertl, Georg

AU - Stoerk, Stefan

AU - Dans, Antonio L.

AU - Lanas, Fernando

AU - Liang, Yan

AU - Zhu, Jun

AU - Torp-Pedersen, Christian

AU - Maggioni, Aldo P.

AU - Commerford, Patrick J.

AU - Guzik, Tomasz J.

AU - Vanassche, Thomas

AU - Verhamme, Peter

AU - O'donnell, Martin

AU - Tonkin, Andrew M.

AU - Varigos, John D.

AU - Vinereanu, Dragos

AU - Felix, Camillo

AU - Kim, Jae Hyung

AU - Ibrahim, Khairul S.

AU - Lewis, Basil S.

AU - Metsarinne, Kaj P.

AU - Aboyans, Victor

AU - Steg, Phillippe Gabriel

AU - Hori, Masatsugu

AU - Kakkar, Ajay

AU - Anand, Sonia S.

AU - Lamy, Andre

AU - Sharma, Mukul

AU - Yusuf, Salim

PY - 2022/12/1

Y1 - 2022/12/1

N2 - Aims: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). Methods and results: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. Conclusion: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.

AB - Aims: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). Methods and results: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. Conclusion: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.

KW - Aspirin

KW - Coronary artery disease

KW - Peripheral artery disease

KW - Rivaroxaban

UR - http://www.scopus.com/inward/record.url?scp=85136221072&partnerID=8YFLogxK

U2 - 10.1093/ehjcvp/pvac023

DO - 10.1093/ehjcvp/pvac023

M3 - Artículo Científico

C2 - 35383832

AN - SCOPUS:85136221072

SN - 2055-6837

VL - 8

SP - 786

EP - 795

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

IS - 8

ER -

Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E et al. Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. European Heart Journal - Cardiovascular Pharmacotherapy. 2022 Dec 1;8(8):786-795. doi: 10.1093/ehjcvp/pvac023

Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial

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