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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
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
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
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
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
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
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
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
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
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
% 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
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
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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Aos 213 01 nelson rivaroxaban effectiveness and safety in nvaf final

  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. % 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. 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. 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