Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism

Abstract

Objective:

The phase III EINSTEIN DVT and EINSTEIN PE trials demonstrated the potential of oral rivaroxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The length of initial hospitalization in patients presenting with either symptomatic DVT or PE was assessed using hospitalization records from these trials.

Methods:

Analyses were carried out in the intention-to-treat population, using non-parametric and parametric statistical methods.

Results:

Overall, 52% (1781/3434) of EINSTEIN DVT patients and 90% (4328/4821) of EINSTEIN PE patients were admitted to hospital. The proportion of hospitalized patients with a length of stay of five or fewer days receiving rivaroxaban was 54% compared with 31% for enoxaparin/vitamin K antagonist (VKA) in patients with DVT. For patients with PE, the corresponding values were 45% and 33%. Stays of 6–10 days were observed in 29% of rivaroxaban-treated patients compared with 45% of enoxaparin/VKA-treated patients for DVT. For patients with PE, these values were 39% and 46% in the rivaroxaban and enoxaparin/VKA groups, respectively. Overall, length of stay was significantly shorter in the rivaroxaban group, compared with the enoxaparin/VKA group across all analyses performed (p < 0.0001). Across regions, the observed admission rates and length of stay duration varied greatly: Asia had the longest overall hospitalization rates, whereas the lowest rates were reported in North America, Australia and New Zealand. Nevertheless, a consistent trend was observed: length of hospital stay in patients with DVT or PE receiving rivaroxaban was shorter than, or at least similar to, patients receiving enoxaparin/VKA.

Conclusion:

A single-drug regimen with rivaroxaban may reduce the burden on healthcare systems and patients, and provides effective and well tolerated treatment. The studies shared an open-label design that allowed comparison of initial hospitalization, but limitations include the well monitored clinical trial setting in which decisions on admission and discharge could vary from real-world management.

Keywords::

• Deep vein thrombosis
• Hospitalization
• Length of stay
• Pulmonary embolism
• Rivaroxaban

Transparency

Declaration of funding

Funding for the study was provided by Bayer HealthCare Pharmaceuticals and Janssen Scientific Affairs LLC. The authors received no payment in preparation of this manuscript.

Declaration of financial/other relationships

B.v.B. has received sponsorship and a research grant from Bayer HealthCare Pharmaceuticals. He is a member of the advisory board for Xarelto and a member of the Bayer HealthCare Pharmaceutical speakers’ bureau. L.B. is an employee of Bayer HealthCare Pharmaceuticals and has stock ownership in Bayer HealthCare Pharmaceuticals. M.P. is a consultant advisor for Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Pfizer, Sanofi and ISIS Pharmaceuticals. F.C.d.C., A.W.A.L., and M.W. are employees of Bayer HealthCare Pharmaceuticals.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors acknowledge Kelly Farrell and Isabel Ruthven, who provided editorial assistance with funding from Bayer HealthCare Pharmaceuticals and Janssen Scientific Affairs LLC.