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DOACs vs. Vitamin K Antagonists During Cardiac Rhythm Device Surgery
Quick Takes
- Patients undergoing cardiac device surgery who use anticoagulants are at risk for bleeding complications.
- Use of interrupted DOAC therapy is associated with less bleeding than continued DOAC therapy, but at higher thrombotic risk.
- Patients using DAPT in addition to anticoagulation were at higher major bleeding risk than those without concurrent DAPT and anticoagulant use.
Study Questions:
What is the incidence of device-related bleeding and thrombotic events for patients using direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) who received interrupted or uninterrupted regimens?
Methods:
The authors conducted an observational two-center study of consecutive patients on chronic oral anticoagulants undergoing cardiac implantable electronic device (CIED) surgery between January 2018 and February 2021. CIED surgeries included new device implantation, upgrade, or replacement. Decisions to interrupt or continue anticoagulation were made by the primary clinician. Groups were matched 1:1 using propensity score methodology. Outcome measures included major bleeding (device-pocket hematoma, tamponade, hemothorax, transfusion, or surgical intervention), the individual components of bleeding, and thromboembolism (stroke, transient ischemic attack, myocardial infarction, pulmonary embolism, peripheral embolism, or deep vein thrombosis) within 30 days of the CIED surgery. A multivariable logistic regression model was developed to identify predictors of major bleeding.
Results:
The study included 1,975 patients (aged 73.8 ± 12.4 years). Among 1,326 patients on DOAC undergoing CIED surgery, 1,039 (78.2%) were interrupted and 287 (21.8%) were uninterrupted. There were 649 patients who used uninterrupted VKA. The rate of major bleeding was higher among patients who continued DOAC therapy (5.2%) as compared to those who interrupted DOAC therapy (1.7%) or who continued VKA therapy (2.1%; p = 0.03). The rate of thromboembolism was 1.4% in the group who interrupted DOAC therapy, while no events occurred in patients on continued DOAC therapy or VKA therapy (p = 0.04). Use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding.
Conclusions:
The authors conclude that continued DOAC therapy was associated with a higher risk of major bleeding but lower risk of thromboembolism for patients undergoing CIED surgery than interrupted DOAC therapy or VKA therapy.
Perspective:
Management of oral anticoagulation therapy for patients undergoing CIED surgery is complicated by competing risks of thromboembolism and bleeding. The BRUISE CONTROL-1 study found that uninterrupted VKA therapy is superior to interrupted therapy. However, the BRUSE CONTROL-2 study comparing interruption to continuous DOAC therapy was stopped early due to low event rates. This real-world data analysis suggests that interrupted DOAC therapy reduces bleeding risk at the cost of increased thrombotic risk. As such, clinicians need to determine if patients are at higher risk of bleeding or thromboembolism to determine if a continuous or interrupted DOAC regimen is most important. All clinicians should strive to reduce bleeding risk by de-prescribing/de-intensifying antiplatelet therapy when possible for patients using oral anticoagulant medications.
Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Cardiac Surgery and Arrhythmias
Keywords: Anticoagulation Therapy, Defibrillators, Implantable
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