Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Number of patients with composite events of stroke or systemic embolism
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Warfarin
New users of warfarin
干预措施: Warfarin (Drug)
Dabigatran
New users of dabigatran
干预措施: Dabigatran (Drug)
Rivaroxaban
New users of rivaroxaban
干预措施: Rivaroxaban (Drug)
Apixaban
New users of apixaban
干预措施: Apixaban (Drug)
Edoxaban
New users of edoxaban
干预措施: Edoxaban (Drug)
结局指标
主要结局
Number of patients with composite events of stroke or systemic embolism
时间窗: 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
时间窗: January 2013 - December 2020 (after drug initiation)
Major bleeding, identified by relevant diagnoses in the claims data
次要结局
- Number of patients with all-cause mortality(January 2013 - December 2020 (after drug initiation))
研究者
Dae Hyun Kim, MD, MPH, ScD
Associate Professor
Brigham and Women's Hospital