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Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System

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Abstract

Introduction

Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population.

Methods

The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student’s t tests were used to compare patients eligible versus ineligible patients.

Results

From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0–$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more).

Conclusion

Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

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Disclaimer

The opinions expressed reflect those of the authors and not necessarily those of the Department of Veterans Affairs or the US government.

Funding

This work was supported by a Department of Veterans Affairs Health Services Research & Development Service Investigator Initiated Grant (IIR 16–072), an American Heart Association Beginning Grant-in-Aid (14BGIA20460366), the American Diabetes Association Clinical Science and Epidemiology award (1-14-CE-44), and the Houston VA Health Services Research & Development Center for Innovations grant (CIN13-413).

Support for VA/CMS data provided by the Department of Veterans Affairs, VA Health Services Research and Development Service, VA Information Resource Center (Project Numbers SDR 02-237 and 98-004).

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Author notes

  1. Akash Kataruka and Dhruv Mahtta contributed equally to this work.

Authors and Affiliations

  1. Division of Cardiology, University of Washington, Seattle, WA, USA

    Akash Kataruka & Ravi S. Hira

  2. Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research & Development Center for Innovations, Houston, TX, USA

    Dhruv Mahtta, Julia M. Akeroyd & Salim S. Virani

  3. Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Boston, MA, USA

    Dhruv S. Kazi

  4. Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA

    Dhruv S. Kazi

  5. Harvard Medical School, Boston, MA, USA

    Dhruv S. Kazi

  6. Saint Luke’s Mid America Heart Institute, Kansas City, MO, USA

    John A. Spertus

  7. University of Missouri-Kansas City, Kansas City, MO, USA

    John A. Spertus

  8. Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA, USA

    Deepak L. Bhatt

  9. Department of Medicine, Section of Cardiology, Baylor College of Medicine, Houston, TX, USA

    Laura A. Petersen

  10. Section of Cardiovascular Research, Department of Medicine, Baylor College of Medicine, Houston, TX, USA

    Christie M. Ballantyne & Salim S. Virani

  11. Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA

    Christie M. Ballantyne & Salim S. Virani

  12. Health Services Research and Development (152), Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Blvd., Houston, TX, 77030, USA

    Salim S. Virani

Authors
  1. Akash Kataruka
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  2. Dhruv Mahtta
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  3. Julia M. Akeroyd
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  6. John A. Spertus
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  7. Deepak L. Bhatt
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  8. Laura A. Petersen
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  10. Salim S. Virani
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Corresponding author

Correspondence to Salim S. Virani.

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Conflict of Interest

AK: supported by T32HL007828 from NHLBI training grant. SSV: supported by research funding from the Department of Veterans Affairs Health Services Research & Development (IIR 16–352,072), World Heart Federation and Tahir and Jooma Family. SSV received honorarium from the American College of Cardiology (Associate Editor for Innovations, acc.org) and serves on the steering committee for the Patient and Provider Assessment of Lipid Management (PALM) registry at the Duke Clinical Research Institute (no financial remuneration). CMB: grant/research support—all significant (all paid to institution, not individual): Akcea, Amgen, Esperion, Novartis, Regeneron, Sanofi-Synthelabo, NIH, AHA, ADA. Consultant—Abbott Diagnostics, Akcea, Amarin, Amgen, Arrowhead, Astra Zeneca, Corvidia, Denka Seiken, Esperion, Intercept, Matinas BioPharma Inc., Merck, Novartis, Regeneron, Sanofi-Synthelabo. RSH: Consultant—Abbott Vascular Inc., ASAHI Intec. JAS: Consultant – Janssen. DLB: Advisory Board: Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, Takeda. DM, LAP, DSK and JMA have no disclosures.

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Kataruka, A., Mahtta, D., Akeroyd, J.M. et al. Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System. Cardiovasc Drugs Ther 35, 533–538 (2021). https://doi.org/10.1007/s10557-020-07061-2

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