December 11, 2008Current Opinion in Cardiology
Bridge or continue Coumadin for device surgery: a randomized controlled trial rationale and design
Why the study?
Does continuing oral anticoagulation reduce clinically significant hematoma compared to bridging anticoagulation in patients requiring cardiac arrhythmia device surgery?
Population
Patients requiring cardiac arrhythmia device surgery who are on chronic oral anticoagulation therapy
Comparison
Continued oral anticoagulation without cessation vs Bridging anticoagulation with temporary…
Design
Randomized, single-blind
Authors
Discussion
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Implication
Planned RCT leaves open optimal periprocedural OAC strategy in device surgery; results will test hematoma reduction with continuation versus bridging.
Key Points
- The study aims to determine whether continuing oral anticoagulation reduces hematoma risk compared to bridging therapy during device surgery.
- Prospective, single-blind, randomized, controlled trial design
- Patients assigned to either bridging anticoagulation or continued oral anticoagulation
- Primary outcome focused on clinically significant hematoma incidence
- Observational data suggest a lower hematoma rate with continued oral anticoagulation strategy
- Bridging anticoagulation is associated with greater risk of arterial thromboembolic events
- The trial addresses a pressing clinical need for over 70,000 patients annually in North America
Structured PICO
Does continuing oral anticoagulation reduce clinically significant hematoma compared to bridging anticoagulation in patients requiring cardiac arrhythmia device surgery?
P
Population
Patients requiring cardiac arrhythmia device surgery who are on chronic oral anticoagulation therapy
I
Intervention
Continued oral anticoagulation without cessation
C
Comparator
Bridging anticoagulation with temporary discontinuation of oral anticoagulation
O
Outcome
Clinically significant hematomasafety
This paper describes the rationale and design of a randomized trial comparing continued oral anticoagulation versus bridging therapy for patients undergoing cardiac device surgery.
Cite This Study
Birnie et al. (2008) studied this question.