Anticoagulant-induced Bleeding, Atrial Fibrillation, Frailty, Stroke
Conditions
Brief summary
The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin K oral anticoagulants (NOAC) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.
Detailed description
Data sources of use for this study are: Medicare Database, Optum Database, and MarketScan Research Database. All data from years 2013-2020 (available data may vary depending on the database) will be analyzed in the study. This study follows a sequential cohort monitoring design. The monitoring analysis will include 1) retrospective analysis of available data (2013-2018) at the time of first analysis (April 2021) and 2) prospective analysis of new data (2019-2020) as they become available to the researchers. Within each database and by frailty status (frail vs non-frail), the investigators will emulate annual updating of data by creating a propensity score (PS)-matched cohort of new users every 1-year interval. Each sequential cohort will be followed for development of the outcomes of interest. At the end of each interval, time-to-event data from all sequential cohorts will be pooled for outcome analysis. The surveillance will be performed by frailty status (frail vs non-frail) at the time of drug initiation.
Interventions
DRUGWarfarin
Initiation of warfarin, identified using prescription fill in pharmacy claims
DRUGDabigatran
Initiation of dabigatran, identified using prescription fill in pharmacy claims
DRUGRivaroxaban
Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
DRUGApixaban
Initiation of apixaban, identified using prescription fill in pharmacy claims
DRUGEdoxaban
Initiation of edoxaban, identified using prescription fill in pharmacy claims
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initiation of a NOAC or warfarin (day 0 is the initiation day) * Continuous enrollment in medical and drug insurance in \[-183, 0\] days * Diagnosis of AF in \[-183, 0\] days * CHA2DS2-VASc score ≥2 (moderate or high risk for stroke) * No prior use of NOAC or warfarin in \[-183, -1\] days * No recent hospitalization for stroke or major bleeding in \[-60, 0\] days * No recent nursing facility stay in \[-60, 0\] days
Exclusion criteria
* Contraindication to either drug in \[-183, 0\] days * Valvular heart disease or mechanical heart valve in \[-183, 0\] days * Intracranial or retroperitoneal hemorrhage in \[-183, 0\] days * Chronic kidney disease stage V, end-stage renal disease, or dialysis in \[-183, 0\] days * Other indications for anticoagulation therapy in \[-183, 0\] days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with composite events of stroke or systemic embolism | January 2013 - December 2020 (after drug initiation) | Stroke OR systemic embolism, identified by relevant diagnoses in the claims data |
| Number of patients with major bleeding | January 2013 - December 2020 (after drug initiation) | Major bleeding, identified by relevant diagnoses in the claims data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with all-cause mortality | January 2013 - December 2020 (after drug initiation) | All-cause mortality is defined by the National Death Index file or vital status information in the claims data. |
Countries
United States
Outcome results
None listed