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Risk of Recurrences in Patients With Unprovoked VTE Who Continued vs Discontinued Rivaroxaban Therapy After 3-Month Therapy
Pulmonary Vascular Disease SESSION TITLE: Pulmonary Embolism: Assessment and Outcomes SESSION TYPE: Original Investigation Slide PRESENTED ON: Sunday, October 23, 2016 at 04:30 PM - 05:30 PM
Risk of Recurrences in Patients With Unprovoked VTE Who Continued vs Discontinued Rivaroxaban Therapy After 3-Month Therapy Jeffrey Berger MD Roger Seheult MD François Laliberté MA Concetta Crivera PharmD Dominique Lejeune MA Yongling Xiao PhD Jeff Schein DrPH Patrick Lefebvre MA; and Scott Kaatz DO* New York University School of Medicine, New York, NY PURPOSE: The American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) recommend treatment with anticoagulation for at least 3 months for patients with VTE. However, data assessing treatment patterns of anticoagulants and associated outcomes in the clinical practice are limited. The objective of this study was to assess the risk of VTE recurrences and major bleeding in a real-world setting of VTE patients with rivaroxaban treatment.
RESULTS: A total of 3,763 and 1,051 rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (standard deviation [SD]) of the observation period was 159.8 (132.7) days in the continued cohort and 178.2 (192.7) days in the discontinued cohort. The Kaplan-Meier analysis showed patients in the continued cohort had significantly lower rates of VTE recurrences at 3 months (0.57% vs. 1.19%), 6 months (1.07% vs. 2.10%), and 12 months (1.45% vs. 2.60%); all log-rank test pvalues < 0.05. No statistically significant differences in the cumulative event rates for major bleeding were observed between the continued and the discontinued cohort at 3 months (0.51% vs. 0.72%), 6 months (0.79% vs. 0.72%), and 12 months (1.06% vs. 1.13%; all p-values > 0.05). CONCLUSIONS: Our study results suggest that patients with unprovoked VTE who received continued therapy after the first 3month treatment with rivaroxaban had significantly lower risk of VTE recurrences without an increasing risk of major bleeding. CLINICAL IMPLICATIONS: Patients receiving continuous rivaroxaban treatment for longer than 3 months had lower risk of VTE recurrences without increasing risk of major bleeding compared to patients receiving the minimal 3 months of therapy treatment. DISCLOSURE: Jeffrey Berger: Consultant fee, speaker bureau, advisory committee, etc.: Janssen Scientific Affairs Roger Seheult: Consultant fee, speaker bureau, advisory committee, etc.: Janssen Scientific Affairs François Laliberté: Grant monies (from industry related sources): Janssen Scientific Affairs Concetta Crivera: Employee: employee of Janssen Scientific Affairs Dominique Lejeune: Grant monies (from industry related sources): Janssen Scientific Affairs Yongling Xiao: Grant monies (from industry related sources): Janssen Scientific Affairs Jeff Schein: Employee: Janssen Scientific Affairs Patrick Lefebvre: Grant monies (from industry related sources): Janssen Scientific Affairs Scott Kaatz: Consultant fee, speaker bureau, advisory committee, etc.: Janssen Scientific Affairs No Product/Research Disclosure Information DOI:
http://dx.doi.org/10.1016/j.chest.2016.08.1264
Copyright ª 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
journal.publications.chestnet.org
1155A
PULMONARY VASCULAR DISEASE
METHODS: A retrospective study was conducted using the Truven Health Analytics MarketScan Databases from 02/2011 to 04/ 2015. The study included adult patients who initiated rivaroxaban therapy within 7 days after their first unprovoked VTEs (i.e., deep vein thrombosis [DVT] and pulmonary embolism [PE]) and continuously used rivaroxaban for at least 3 months. Unprovoked VTE was defined as not having recent surgery, cancer, pregnancy or estrogen therapy. The end of the first 3-month rivaroxaban treatment was defined as the index date. Patients treated for 3 months formed the discontinued cohort and patients treated for more than 3 months formed the continued cohort. Patients were followed from index date until end of continuous treatment for the continued cohort or end of data or re-initiation of oral anticoagulant therapy for the discontinued cohort. The outcomes included VTE recurrences identified as primary diagnosis documented during hospitalizations and major bleeding events identified by a validated algorithm (Cunningham et al., 2011). Kaplan-Meier rates for VTE recurrences and major bleeding events at 3, 6, and 12 months after the index date were compared between cohorts with adjustment for baseline confounding using the inverse probability of treatment weights (IPTW) method based on propensity score.
Risk of Recurrences in Patients With Unprovoked VTE Who Continued vs Discontinued Rivaroxaban Therapy After 3-Month Therapy Jeffrey Berger MD Roger Seheult MD François Laliberté MA Concetta Crivera PharmD Dominique Lejeune MA Yongling Xiao PhD Jeff Schein DrPH Patrick Lefebvre MA; and Scott Kaatz DO* New York University School of Medicine, New York, NY PURPOSE: The American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) recommend treatment with anticoagulation for at least 3 months for patients with VTE. However, data assessing treatment patterns of anticoagulants and associated outcomes in the clinical practice are limited. The objective of this study was to assess the risk of VTE recurrences and major bleeding in a real-world setting of VTE patients with rivaroxaban treatment.
RESULTS: A total of 3,763 and 1,051 rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (standard deviation [SD]) of the observation period was 159.8 (132.7) days in the continued cohort and 178.2 (192.7) days in the discontinued cohort. The Kaplan-Meier analysis showed patients in the continued cohort had significantly lower rates of VTE recurrences at 3 months (0.57% vs. 1.19%), 6 months (1.07% vs. 2.10%), and 12 months (1.45% vs. 2.60%); all log-rank test pvalues < 0.05. No statistically significant differences in the cumulative event rates for major bleeding were observed between the continued and the discontinued cohort at 3 months (0.51% vs. 0.72%), 6 months (0.79% vs. 0.72%), and 12 months (1.06% vs. 1.13%; all p-values > 0.05). CONCLUSIONS: Our study results suggest that patients with unprovoked VTE who received continued therapy after the first 3month treatment with rivaroxaban had significantly lower risk of VTE recurrences without an increasing risk of major bleeding. CLINICAL IMPLICATIONS: Patients receiving continuous rivaroxaban treatment for longer than 3 months had lower risk of VTE recurrences without increasing risk of major bleeding compared to patients receiving the minimal 3 months of therapy treatment. DISCLOSURE: Jeffrey Berger: Consultant fee, speaker bureau, advisory committee, etc.: Janssen Scientific Affairs Roger Seheult: Consultant fee, speaker bureau, advisory committee, etc.: Janssen Scientific Affairs François Laliberté: Grant monies (from industry related sources): Janssen Scientific Affairs Concetta Crivera: Employee: employee of Janssen Scientific Affairs Dominique Lejeune: Grant monies (from industry related sources): Janssen Scientific Affairs Yongling Xiao: Grant monies (from industry related sources): Janssen Scientific Affairs Jeff Schein: Employee: Janssen Scientific Affairs Patrick Lefebvre: Grant monies (from industry related sources): Janssen Scientific Affairs Scott Kaatz: Consultant fee, speaker bureau, advisory committee, etc.: Janssen Scientific Affairs No Product/Research Disclosure Information DOI:
http://dx.doi.org/10.1016/j.chest.2016.08.1264
Copyright ª 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
journal.publications.chestnet.org
1155A
PULMONARY VASCULAR DISEASE
METHODS: A retrospective study was conducted using the Truven Health Analytics MarketScan Databases from 02/2011 to 04/ 2015. The study included adult patients who initiated rivaroxaban therapy within 7 days after their first unprovoked VTEs (i.e., deep vein thrombosis [DVT] and pulmonary embolism [PE]) and continuously used rivaroxaban for at least 3 months. Unprovoked VTE was defined as not having recent surgery, cancer, pregnancy or estrogen therapy. The end of the first 3-month rivaroxaban treatment was defined as the index date. Patients treated for 3 months formed the discontinued cohort and patients treated for more than 3 months formed the continued cohort. Patients were followed from index date until end of continuous treatment for the continued cohort or end of data or re-initiation of oral anticoagulant therapy for the discontinued cohort. The outcomes included VTE recurrences identified as primary diagnosis documented during hospitalizations and major bleeding events identified by a validated algorithm (Cunningham et al., 2011). Kaplan-Meier rates for VTE recurrences and major bleeding events at 3, 6, and 12 months after the index date were compared between cohorts with adjustment for baseline confounding using the inverse probability of treatment weights (IPTW) method based on propensity score.