Alok A Khorana1, Jeffrey S Berger2, Philip S Wells3, Roger Seheult4, Veronica Ashton5, François Laliberté6, Concetta Crivera5, Dominique Lejeune7, Jeff Schein5, Peter Wildgoose5, Patrick Lefebvre6, Scott Kaatz8. 1. Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio. 2. New York University School of Medicine, New York, New York. 3. The Ottawa Hospital, Ottawa, Ontario, Canada. 4. Loma Linda University School of Medicine, Loma Linda, California. 5. Janssen Scientific Affairs, LLC, Raritan, New Jersey. 6. Groupe d'analyse, Ltée, Montréal, Québec, Canada. 7. Groupe d'analyse, Ltée, Montréal, Québec, Canada. Electronic address: dominique.lejeune@analysisgroup.com. 8. Henry Ford Hospital, Detroit, Michigan.
Abstract
PURPOSE: The EINSTEIN-Extension trial showed that an extended rivaroxaban treatment significantly reduced the risk for venous thromboembolic (VTE) recurrence. The present study assessed the risk for VTE recurrence and major bleeding associated with extended rivaroxaban treatment in a clinical practice setting among patients with VTE. METHODS: A retrospective study was conducted using claims data from February 2011 to April 2015. It included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and who continuously used rivaroxaban for at least 3 months (index date: end of initial 3-month treatment). Categorized into discontinued and continued cohorts, patients were followed up from the index date until the end of continuous treatment (continued cohort) or end of data or reinitiation of oral anticoagulant therapy (discontinued cohort). Using inverse probability of treatment weights controlling for confounders, adjusted Kaplan-Meier rates of recurrent VTE and major bleeding events were compared. FINDINGS: The analysis showed that, compared with the discontinued cohort (n = 1,536), the continued cohort (n = 5,933) had a significantly lower VTE recurrence rate after an additional 3 months (0.70% vs 1.70%), 6 months (1.41% vs 2.34%), 9 months (1.82% vs 3.01%), and 12 months (1.97% vs 3.01%) of treatment (all, p < 0.05). The difference in the cumulative event rates for major bleeding was not statistically significant. Similar results were obtained in an analysis among patients with VTE receiving rivaroxaban for ≥6 months. IMPLICATIONS: Our results suggest that, in clinical practice settings, patients with VTE who continued rivaroxaban therapy after the initial 3- or 6-month treatment period had a significantly lower risk for VTE recurrence without a statistically significant increased risk for major bleeding.
PURPOSE: The EINSTEIN-Extension trial showed that an extended rivaroxaban treatment significantly reduced the risk for venous thromboembolic (VTE) recurrence. The present study assessed the risk for VTE recurrence and major bleeding associated with extended rivaroxaban treatment in a clinical practice setting among patients with VTE. METHODS: A retrospective study was conducted using claims data from February 2011 to April 2015. It included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and who continuously used rivaroxaban for at least 3 months (index date: end of initial 3-month treatment). Categorized into discontinued and continued cohorts, patients were followed up from the index date until the end of continuous treatment (continued cohort) or end of data or reinitiation of oral anticoagulant therapy (discontinued cohort). Using inverse probability of treatment weights controlling for confounders, adjusted Kaplan-Meier rates of recurrent VTE and major bleeding events were compared. FINDINGS: The analysis showed that, compared with the discontinued cohort (n = 1,536), the continued cohort (n = 5,933) had a significantly lower VTE recurrence rate after an additional 3 months (0.70% vs 1.70%), 6 months (1.41% vs 2.34%), 9 months (1.82% vs 3.01%), and 12 months (1.97% vs 3.01%) of treatment (all, p < 0.05). The difference in the cumulative event rates for major bleeding was not statistically significant. Similar results were obtained in an analysis among patients with VTE receiving rivaroxaban for ≥6 months. IMPLICATIONS: Our results suggest that, in clinical practice settings, patients with VTE who continued rivaroxaban therapy after the initial 3- or 6-month treatment period had a significantly lower risk for VTE recurrence without a statistically significant increased risk for major bleeding.
Authors: Pablo Demelo-Rodríguez; Francisco Galeano-Valle; Irene García-Fernández-Bravo; Sandra Piqueras-Ruiz; Luis Álvarez-Sala-Walther; Jorge Del Toro-Cervera Journal: Medicine (Baltimore) Date: 2019-01 Impact factor: 1.817
Authors: Jeffrey S Berger; Roger Seheult; François Laliberté; Concetta Crivera; Dominique Lejeune; Yongling Xiao; Jeff Schein; Patrick Lefebvre; Scott Kaatz Journal: Res Pract Thromb Haemost Date: 2017-11-15