Objective: To compare the rate of stroke / systemic embolism and major bleeding in non-valvular AF patients prescribed ELIQUIS^®, rivaroxaban, dabigatran, or warfarin³

Propensity score matching of each of the six cohorts in ARISTOPHANES helped to account for key baseline characteristics⁴

Propensity score matching of each of the six cohorts in ARISTOPHANES helped to account for key baseline characteristics³

Following PSM, the patient populations in ARISTOPHANES displayed similar baseline characteristics between treatment groups^​3

ARISTOTLE clinical trial demonstrated similar baseline characteristics of the patients between the two groups (Eliquis vs. Warfarin). In patients with atrial fibrillation, Eliquis was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.²

Methods: Randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke.²​

Objective: The primary outcome was ischemic or hemorrhagic stroke or systemic embolism and secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.^​2

A full list of baseline characteristics from the ARISTOPHANES real-world analysis and the ARISTOTLE clinical trial can be found in their respective publications.^2,3​

*End date was selected as it was the last date before the US moved from ICD-9 codes to ICD-10 codes. Due to this coding switch, the researchers wanted to keep outcome definitions consistent.³
†Data in this study were pooled from the US Centres for Medicare and Medicaid Services Medicare data, and commercial claims databases in the US: Truven MarketScan®, IMS PharMetrics PlusTM, Optum® Clinformatics® Data Mart, and the Humana Research database.^​3
‡Patients were matched 1:1 in each dataset, using propensity scores generated by logistic regression based on demographics, Charlson Comorbidity Index (CCI) score, baseline bleeding and stroke / systemic embolism history, comorbidities, and baseline co-medications.³
§Outcomes were based on hospitalisations with stroke / systemic embolism or major bleeding as the principal or first listed diagnosis.^​3
#In ARISTOTLE, the primary objective to determine whether ELIQUIS® was non-inferior to warfarin in reducing the rate of stroke (ischaemic or haemorrhagic) or systemic embolism among nonvalvular AF patients with at least one other risk factor for stroke. The primary safety outcome was major bleeding, according to the ISTH criteria.² In the ARISTOPHANES US real-world analysis, the primary effectiveness outcome was stroke / systemic embolism, including ischæmic stroke, haemorrhagic stroke, and systemic embolism. The primary safety outcome was stroke / systemic embolism, including ischaemic stroke, haemorrhagic stroke, and systemic embolism. The primary safety outcome was major bleeding, including gastrointestinal bleeding, intracranial bleeding, and bleeding from other sites. The analysis included outcomes that occurred on treatment, and were identified using the ICD-9 codes given as the principal first listed diagnosis of inpatient claims.^​3

AF: Atrial Fibrillation; ICD-9: International Classification of Diseases, 9th Revision; ISTH: International Society on Thrombosis and Haemostasis; NOAC: Non-vitamin K antagonist Oral Anticoagulant; OAC: Oral Anticoagulant; PSM: Propensity Score Matching; RCT: Randomised Controlled Trial.

Adapted from Lip GYH, et al. Stroke. 2018^3​

ELIQUIS® was associated with lower rate of stroke/SE and major bleeding compared with dabigatran (stroke/SE: HR, 0.72; 95% CI, 0.60–0.85; MB: HR, 0.78; 95% CI, 0.70–0.87)^​3

Adapted from Lip GYH, et al. Stroke. 2018³​

SE, systemic embolism; MB, major bleeding; HR, hazard ratio; CI, confidence interval.

References: 1. Eliquis 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992. 3. Lip GYH, Keshishian A, Li X, et al. Effectiveness and safety of Oral Anticoagulants among nonvalvular atrial fibrillation Patients. Stroke. 2018;49(12):2933-2944.

Adapted from Lip GYH, et al. Stroke. 2018^​

Propensity score–matched hazard ratios of major bleeding for Eliquis® vs. rivaroxaban across subgroups favors Eliquis®^3​

Adapted from Lip GYH, et al. Stroke. 2018^​

Propensity score–matched hazard ratios of major bleeding for Eliquis® vs. dabigatran across subgroups favors Eliquis®³

Adapted from Lip GYH, et al. Stroke. 2018^​

*Outcomes were identified using ICD-9 codes in the principal or first listed diagnosis positions of inpatient claims.^​4
†When examining ELIQUIS vs. rivaroxaban, the following doses were used after propensity score matching: 76.8% of ELIQUIS patients received the standard dose of ELIQUIS 5 mg BD and 23.2% of patients received a reduced dose of ELIQUIS 2.5 mg BD; 70.5% of rivaroxaban patients received the standard dose of rivaroxaban 20 mg QD and 29.6% of patients received a reduced dose of rivaroxaban 10 / 15 mg QD.⁴​
‡When examining ELIQUIS vs. dabigatran, the following doses were used after propensity score matching: 82.0% of ELIQUIS patients received the standard dose of ELIQUIS 5 mg BD and 18.0% of patients received a reduced dose of ELIQUIS 2.5 mg BD; 84.0% of dabigatran patients received the standard dose of dabigatran 150 mg BD and 16.0% of patients received a reduced dose of dabigatran 75 mg BD.⁴

BD, Twice daily; CHA₂DS₂-VASc, Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular Disease, Age 65–74, Sex category (female); CI, Confidence Interval; HAS-BLED, Hypertension, Abnormal renal or liver function, Stroke, Bleeding, Labile international normalised ratio (INR), Elderly (>65 years), Drugs (nonsteroidal anti-inflammatory drug [NSAID], antiplatelets, alcohol); HR, Hazard Ratio; ICD-9, International Classification of Diseases, 9th Revision, NOAC, Non-vitamin K antagonist Oral Anticoagulant; PAD, Peripheral Artery Disease;PSM, Propensity Score Matching, QD, Once Daily; RCT, Randomised Controlled trial; SE, Systemic Embolism.

Adapted from Lip et al. 2018.³

ELIQUIS® was associated with a more favourable or comparable rate of stroke/systemic embolism rivaroxaban³

Adapted from Lip GYH, et al. Stroke. 2018^1​

ELIQUIS® was associated with more favourable or comparable rate of stroke / systemic  embolism vs. dabigatran (HR, 0.72; 95% CI, 0.60–0.85), with significant interactions between some patient subgroups^​3

Adapted from Lip GYH, et al. Stroke. 2018^1​

*Outcomes were identified using ICD-9 codes in the principal or first listed diagnosis positions of inpatient claims.^​4

†When examining ELIQUIS vs. rivaroxaban, the following doses were used after propensity score matching: 76.8% of ELIQUIS patients received the standard dose of ELIQUIS 5 mg BD and 23.2% of patients received a reduced dose of ELIQUIS 2.5 mg BD; 70.5% of rivaroxaban patients received the standard dose of rivaroxaban 20 mg QD and 29.6% of patients received a reduced dose of rivaroxaban 10 / 15 mg QD.⁴

‡When examining ELIQUIS vs. dabigatran, the following doses were used after propensity score matching: 82.0% of ELIQUIS patients received the standard dose of ELIQUIS 5 mg BD and 18.0% of patients received a reduced dose of ELIQUIS 2.5 mg BD; 84.0% of dabigatran patients received the standard dose of dabigatran 150 mg BD and 16.0% of patients received a reduced dose of dabigatran 75 mg BD.^​4

BD: Twice daily, CHA₂DS₂-VASc: Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular Disease, Age 65–74, Sex category (female); CI: Confidence Interval; HAS-BLED: Hypertension, Abnormal renal or liver function, Stroke, Bleeding, Labile international normalised ratio (INR), Elderly (>65 years), Drugs (nonsteroidal anti-inflammatory drug [NSAID], antiplatelets, alcohol); HR: Hazard Ratio; ICD-9: International Classification of Diseases, 9th Revision, NOAC: Non-vitamin K antagonist Oral Anticoagulant; PAD: Peripheral Artery Disease; PSM: Propensity Score Matching, QD: Once Daily; RCT: Randomised Controlled trial; SE: Systemic Embolism.​