Author + information
- Scott Kaatz,
- Jeffrey Berger,
- Philip S. Wells,
- Roger Seheult,
- Veronica Ashton,
- François Laliberté,
- Concetta Crivera,
- Dominique Lejeune,
- Yongling Xiao,
- Jeff Schein,
- Peter Wildgoose,
- Patrick Lefebvre and
- Alok A. Khorana
Background: A benefit-risk analysis using the EINSTEIN-extension trial data showed that extended rivaroxaban treatment has a favorable profile compared with placebo. In this study, we assessed the benefit-risk of extended rivaroxaban treatment (vs. 6 months of treatment) in a real-world setting among VTE patients.
Methods: Truven Health Analytics MarketScan Databases data (02/2011 to 04/2015) was used. The study included adult patients who initiated rivaroxaban within 7 days after a first VTE and were treated for at least 6 months. Patients treated for 6 months were compared to patients that received extended treatment beyond 6 months. The reciprocal of the one-year Kaplan-Meier (KM) rate differences of recurrent VTE, major bleeding event, and composite recurrent VTE or major bleeding was used to calculate number needed to treat (NNT), number needed to harm (NNH), and net clinical benefit (NCB), respectively, among the overall and unprovoked VTE populations. Baseline confounding was controlled for using the inverse probability of treatment weights method based on propensity score.
Results: A total of 2,676 and 1,127 (65.9% and 70.4% unprovoked VTE, respectively) rivaroxaban users formed the 6-month and extended treatment cohorts, respectively. In the overall analysis, the 1-year KM rate difference of recurrent VTE was 1.98% (extended vs. 6-month: 1.72% vs. 3.70%, log-rank p = 0.02) indicating that one recurrent VTE would be avoided for every 51 (NNT) patients receiving extended treatment. There was no significant difference in major bleeding events between the extended vs. 6-month cohorts (extended vs. 6-month: 1.53% vs. 1.32%, log-rank p = 0.79).
Conclusions: Patients receiving rivaroxaban extended treatment more than 6 months have a favorable benefit-risk profile compared to patients receiving rivaroxaban for 6 months.
Room 147 B
Saturday, March 18, 2017, 8:12 a.m.-8:22 a.m.
Session Title: Highlighted Original Research: Pulmonary Hypertension and Venous Thrombo-embolic Disease and the Year in Review
Abstract Category: 35. Pulmonary Hypertension and Pulmonary Thrombo-embolic Disease
Presentation Number: 904-04
- 2017 American College of Cardiology Foundation