Utilization, Safety, and Effectiveness of Direct Oral Anticoagulants in Non-Valvular Atrial Fibrillation

Project number: 
17-117
Approval date: 
Friday, September 22, 2017
Principal Investigator: 
Dormuth,Colin
Institution: 
University of British Columbia (UBC)
Funding Agency: 
Canadian Institutes of Health Research(CIHR)
Datasets requested: 
Not available
Research objective: 

RESEARCH QUESTIONS

Part 1: Safety and effectiveness (using intention to treat approach)

This part focuses on the following outcomes: stroke or systemic embolization, major bleeding, GI bleeding, all-cause mortality, and myocardial infarction in patients with non-valvular atrial fibrillation (NVAF).

- Objective 1: In matched cohorts of warfarin vs. DOAC users, estimate rates and compare the risk of the above outcomes (class comparison).

- Objective 2: In matched cohorts of dabigatran vs. rivaroxaban users, dabigatran vs apixaban users, and rivaroxaban vs. apixaban users, estimate rates and compare the risk of the above outcomes (head-to-head comparisons).

Part 2: Risk of major bleeding (using on-treatment approach) and utilization in patients with NVAF

- Objective 3: Compare the risk of major bleeding associated with use of DOACs vs. vitamin K antagonists (VKAs). Subgroup analysis includes patients that have chronic kidney disease, hepatic impairment, are elderly and are taking a contraindicated medication at the same time.

- Objective 4: Describe the utilization of DOACs in BC patients with NVAF, and characterize new DOAC users.

HYPOTHESES

- Objective 1: Safety and effectiveness of DOACs and warfarin for all end points will be similar.
- Objective 2: Different DOACs (dabigatran, rivaroxaban, apixaban) will have similar safety profiles.
- Objective 3: The risk of major bleeding of DOACs and VKAs will be similar in all subgroups.
- Objective 4: This is a descriptive study of utilization - no specific hypothesis is required.


Page last revised: October 3, 2017