Real-world evidence on patients aged 80 and older presented from ARISTOPHANES study evaluating oral anticoagulants among patients with non-valvular atrial fibrillation- BMS + Pfizer

The Bristol-Myers Squibb-Pfizer Alliance presented new real-world evidence (RWE) from a sub-analysis of the ARISTOPHANES study comparing the safety and effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs), including Eliquis (apixaban), in non-valvular atrial fibrillation (NVAF) patient populations aged 80 and older (n=46,208).

In the analysis, apixaban use was associated with lower rates of both stroke/systemic embolism (S/SE) and major bleeding (MB) compared to dabigatran ([S/SE hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.47-0.89]; [MB HR: 0.60, 95% CI: 0.49-0.73]) or rivaroxaban ([S/SE HR: 0.72, 95% CI: 0.59-0.86]; [MB HR: 0.50, 95% CI: 0.45-0.55]). Dabigatran was associated with lower rates of MB compared to rivaroxaban (HR: 0.77, 95% CI: 0.67-0.90). Comprehensive details of this retrospective database analysis are included in the study details section below. Please note that Eliquis increases the risk of bleeding and can cause serious, potentially fatal, bleeding.

In this sub-analysis of the ARISTOPHANES study (NCT03087487), patients aged 80 years and older with NVAF who initiated NOACs (apixaban, dabigatran, rivaroxaban) between January 1, 2013 and September 30, 2015 were identified using CMS Medicare and three U.S. commercial claims databases. These four databases cover more than 123 million beneficiaries annually (~38 percent of U.S. population). This analysis included pre-specified outcomes and utilized a statistical method called propensity score matching designed to help balance the characteristics in each treatment group. However, as with all real-world data analyses, the source and type of RWE may limit how results and outcomes can be applied to other patient populations. RWE studies should be used in conjunction with clinical trial evidence to support healthcare decision making. Under-treatment with anticoagulants is frequently seen among elderly populations, perhaps due to the increased bleeding risk that accompanies aging. Additional RWE from a sub-analysis of the ARISTOPHANES study comparing the safety and effectiveness of apixaban, rivaroxaban and dabigatran to warfarin in NVAF patients 80 years of age and older were also presented as a moderated poster.

One-to-one propensity score matching was conducted between each NOAC cohort, and Cox proportional hazards models were used to estimate the hazard ratios of S/SE and MB. Apixaban was associated with lower rates of both S/SE (HR: 0.65, 95% CI: 0.47-0.89, p=0.008) and lower rates of MB (HR: 0.60, 95% CI: 0.49-0.73, p<0.001) compared to dabigatran n="12,954)." apixaban was associated with lower rates of both s se hr: 0.72 95 ci: 0.59-0.86 p><0.001) and lower rates of mb hr: 0.50 95 ci: 0.45-0.55 p><0.001) compared to rivaroxaban n="37,116)." dabigatran was associated with lower rates of mb hr: 0.77 95 ci: 0.67-0.90 p><0.001) compared to rivaroxaban there was no statistically significant difference in s se rates for dabigatran compared to rivaroxaban hr: 1.11 95 ci: 0.84-1.46 p="0.481)" n="13,366)." limitations of real-world data analyses: real-world data have the potential to complement randomized controlled trial data by providing additional information about how a medicine performs in routine medical practice.>

Real-world data analyses have several limitations. For example, the source and type of data used may limit the generalizability of the results and of the endpoints. Observational real-world studies can only evaluate association and not causality. Due to these limitations, real-world data analyses are not used as stand-alone evidence to validate the efficacy and/or safety of a treatment. It is important to note that, at this time, there are no head-to-head clinical trials comparing direct oral anticoagulants.

BMS-Pfizer Alliance Real-Word Data (RWD) Program: ARISTOPHANES is part of the Bristol-Myers Squibb-Pfizer Alliance global RWD analysis program, ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program currently includes analyses of patients from 19 databases around the world, including anonymized medical records, medical and pharmacy health insurance claims data, and national health data systems. To date, the ACROPOLIS program includes a sample size of more than one million lives spanning 11 countries.

See-Lip GHY, Keshishian, Li X, et al. EEffectiveness and Safety of Non-Vitamin K Antagonist Oral Anticoagulants Among Very Elderly Patients with Non-Valvular Atrial Fibrillation: An Observational Study". Presented at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, Illinois.