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 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 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

23 Citations (Scopus)

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
Journal	European heart journal. Cardiovascular pharmacotherapy
Volume	8
Issue number	8
Pages (from-to)	786-795
Number of pages	10
ISSN	2055-6837
DOIs	https://doi.org/10.1093/ehjcvp/pvac023
Publication status	Published - 2 Dec 2022
Externally published	Yes

Keywords

Aspirin
Drug Therapy, Combination
Humans
Infant
Myocardial Infarction/epidemiology
Peripheral Arterial Disease/diagnosis
Rivaroxaban
Stroke/epidemiology

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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., 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

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, 02.12.2022, p. 786-795.

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

Eikelboom, JW, Bosch, J, Connolly, SJ, Tyrwitt, J, Fox, KAA, Muehlhofer, E, Neumann, C, Tasto, C, Bangdiwala, S, 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, J-H, 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

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 2;8(8):786-795. Epub 2022 Apr 6. doi: 10.1093/ehjcvp/pvac023

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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, Drug Therapy, Combination, Humans, Infant, Myocardial Infarction/epidemiology, Peripheral Arterial Disease/diagnosis, Rivaroxaban, Stroke/epidemiology",

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 Shrikant Bangdiwala 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 Jae-Hyung Kim 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 = "{\textcopyright} The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.",

year = "2022",

month = dec,

day = "2",

doi = "10.1093/ehjcvp/pvac023",

language = "English",

volume = "8",

pages = "786--795",

journal = "European heart journal. Cardiovascular pharmacotherapy",

issn = "2055-6837",

publisher = "Oxford University Press",

number = "8",

}

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

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 - 2022/12/2

Y1 - 2022/12/2

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 - Drug Therapy, Combination

KW - Humans

KW - Infant

KW - Myocardial Infarction/epidemiology

KW - Peripheral Arterial Disease/diagnosis

KW - Rivaroxaban

KW - Stroke/epidemiology

UR - https://www.scopus.com/pages/publications/85136221072

U2 - 10.1093/ehjcvp/pvac023

DO - 10.1093/ehjcvp/pvac023

M3 - Journal article

C2 - 35383832

SN - 2055-6837

VL - 8

SP - 786

EP - 795

JO - European heart journal. Cardiovascular pharmacotherapy

JF - European heart journal. Cardiovascular pharmacotherapy

IS - 8

ER -

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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