Real-World Comparative Effectiveness
and Safety of Rivaroxaban and Warfarin
in Nonvalvular Atrial Fibrillation Patients
Fr...
Disclosures
● Financial support for the research was provided in whole by Janssen

Scientific Affairs, LLC (JSA)

● Franço...
Background
● Chronic anticoagulants are regularly used in the prevention of

stroke in patients with nonvalvular atrial fi...
Methods - Data Source
Symphony Health Solutions Patient Transactional Datasets from
May 2011 to July 2012
• Longitudinal p...
Methods - Study Sample
Inclusion criteria
• Newly initiated on rivaroxaban or warfarin (at least 180 days of
clinical acti...
Methods - Study Design
● Retrospective matched-cohort design ensured groups were well

balanced at baseline
● Each rivarox...
Methods - Study Endpoints
● Safety
• Major bleeding
• Gastrointestinal (GI) bleeding
● Effectiveness*
• Composite stroke a...
Statistical Methods
● Descriptive statistics to summarize the patient characteristics and

compared using standardized dif...
Patients Characteristics
Matched Cohort
Characteristics

Warfarin

(N=3,654)
Demographics
Age, years, mean (SD)
Gender, fe...
Hazard Ratios of Study Endpoints
Rivaroxaban vs. Warfarin
Hazard Ratios [95% CI]
Major bleeding

1.03 [0.68 - 1.56]

GI bl...
% of patients persistent with treatment

Treatment Persistence
100%

HR = 0.66 (0.60-0.72), P<0.001
90%

85%
81%

80%

War...
Limitations
● Claims database may contain inaccuracies or omissions in coded

procedures, diagnoses, or pharmacy claims

●...
Conclusions
● This analysis suggests that rivaroxaban and warfarin do not

differ significantly in real-world rates of com...
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Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final

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Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final

  1. 1. Real-World Comparative Effectiveness and Safety of Rivaroxaban and Warfarin in Nonvalvular Atrial Fibrillation Patients François Laliberté1; Michel Cloutier1; Winnie W. Nelson2; Craig I. Coleman3; Dominic Pilon1; CV Damaraju2; Jeffrey R. Schein2; Patrick Lefebvre1 1Analysis Group, Inc., Boston, MA; 2Janssen Scientific Affairs, LLC, Raritan, NJ; 3Univ of Connecticut & Hartford Hosp, Hartford, CT; AHA Scientific Session, November 16-20, 2013, Dallas, TX 1
  2. 2. Disclosures ● Financial support for the research was provided in whole by Janssen Scientific Affairs, LLC (JSA) ● François Laliberté, Michel Cloutier, Dominic Pilon, and Patrick Lefebvre are employees of Analysis Group Inc., a consulting company that has received research grants from JSA ● Craig I. Coleman is a Professor at University of Connecticut School of Pharmacy and Co-Director of the University of Connecticut/Hartford Hospital Evidence-Based Practice Center. He has received research grants from JSA and serves as a member of Janssen speaker bureau ● Winnie W. Nelson, CV Damaraju, and Jeffrey R. Schein are employees of JSA and stockholders of Johnson & Johnson 2
  3. 3. Background ● Chronic anticoagulants are regularly used in the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF) ● Until recently, warfarin and other oral vitamin-K antagonist (VKA) anticoagulants were the only oral anticoagulants available for stroke prevention ● Target-specific oral anticoagulants (e.g., rivaroxaban, dabigatran, apixaban) were approved for the prevention of stroke and systemic embolism in patients with NVAF ● The ROCKET-AF trial has demonstrated that rivaroxaban is effective in reducing the risk of stroke and systemic embolism ● The objective of this study was to assess real-world effectiveness, safety, and patients’ continued use of rivaroxaban and warfarin (i.e. persistence) 3
  4. 4. Methods - Data Source Symphony Health Solutions Patient Transactional Datasets from May 2011 to July 2012 • Longitudinal patient data source with data from adjudicated medical and pharmacy claims • Contains approximately 4.8 billion prescription claims across the U.S. for all payment types (e.g., commercials plans, Medicare Part D, assistance programs, and Medicaid) • Linked with claims from hospital and physician practices for over 190 million patients • Data de-identified in compliance with HIPAA 4
  5. 5. Methods - Study Sample Inclusion criteria • Newly initiated on rivaroxaban or warfarin (at least 180 days of clinical activity prior to the index date) • Age greater than or equal to 18 years • CHADS2 score ≥1 during the 180-day baseline period • ≥2 AF diagnoses (ICD-9-CM: 427.31) during baseline or follow-up Exclusion criteria • Patients with the following conditions: ─ Valvular involvement ─ Pregnancy ─ Malignant cancer ─ Transient causes of AF 5
  6. 6. Methods - Study Design ● Retrospective matched-cohort design ensured groups were well balanced at baseline ● Each rivaroxaban user matched with up to 4 warfarin users based on propensity score ● The observation period spanned from the index date until: − End of clinical activity, or − End of data availability ● In addition, for clinical endpoints, observation period is further restricted to − Switch of anticoagulant, or − 14 days after treatment discontinuation 6
  7. 7. Methods - Study Endpoints ● Safety • Major bleeding • Gastrointestinal (GI) bleeding ● Effectiveness* • Composite stroke and systemic embolism ─ Ischemic stroke ─ Hemorrhagic stroke ─ Systemic embolism • Venous thromboembolism (VTE) ─ Deep vein thrombosis (DVT) only ─ Pulmonary embolism (PE) with or without DVT ● Medication persistence to the index therapy * Events identified during a hospitalization or emergency department visit 7
  8. 8. Statistical Methods ● Descriptive statistics to summarize the patient characteristics and compared using standardized differences ● Cox proportional hazard regressions to calculate hazard ratios (HRs) of bleeding (major and GI), composite stroke and systemic embolism, and VTE events between groups ● Kaplan-Meier estimates and HRs to compare the time to non- persistence − Non-persistence defined as having a refill gap of 60 days or larger 8
  9. 9. Patients Characteristics Matched Cohort Characteristics Warfarin (N=3,654) Demographics Age, years, mean (SD) Gender, female, n (%) Quan-Charlson comorbidity index CHADS2 score Selected baseline risk factors , n(%) Age > 60 Prior stroke Hypertension Hyperlipidemia Diabetes Heart failure Rivaroxaban (N=13,876) Standardized Difference 73.3 (8.4) 1,865 (51.0%) 1.1 (1.3) 2.0 (1.0) 73.7 (8.3) 7,159 (51.6%) 1.2 (1.4) 2.0 (1.0) 4.6% 1.1% 3.3% 2.2% 3,313 (90.7%) 357 (9.8%) 2,626 (71.9%) 1,616 (44.2%) 919 (25.2%) 716 (19.6%) 12,681 (91.4%) 1434 (9.8%) 9,761 (70.3%) 6,032 (43.5%) 3,599 (25.9%) 2,858 (20.6%) 2.5% 3.4% 3.4% 1.5% 1.8% 2.5% 9
  10. 10. Hazard Ratios of Study Endpoints Rivaroxaban vs. Warfarin Hazard Ratios [95% CI] Major bleeding 1.03 [0.68 - 1.56] GI bleeding Composite stroke and systemic embolism† Ischemic stroke† 1.26 [0.98 - 1.62] Hemorrhagic stroke† 1.10 [0.12 - 9.86] Systemic embolism† 0.78 [0.17 - 3.50] DVT only† 0.55 [0.25 - 1.21] PE with or without DVT† 1.06 [0.40 - 2.80] 0.81 [0.58 - 1.15] 0.83 [0.59 - 1.18] 0 Rivaroxaban better 1 2 3 Warfarin better †Event identified during a hospitalization or emergency department visit 10
  11. 11. % of patients persistent with treatment Treatment Persistence 100% HR = 0.66 (0.60-0.72), P<0.001 90% 85% 81% 80% Warfarin User Cohort Rivaroxaban User Cohort 70% 76% 68% 60% 0 30 60 90 120 Time to event (days) 150 180 11
  12. 12. Limitations ● Claims database may contain inaccuracies or omissions in coded procedures, diagnoses, or pharmacy claims ● Propensity score matching only accounts for observable factors ● Despite matching, the observational nature of the analysis still carries the possibility of confounding ● Study was conducted when rivaroxaban was first available; use patterns may change over time 12
  13. 13. Conclusions ● This analysis suggests that rivaroxaban and warfarin do not differ significantly in real-world rates of composite stroke and systemic embolism, major bleeding, and GI bleeding ● Rivaroxaban was associated with a significantly higher treatment persistence compared with warfarin 13

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