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BRUISE CONTROL-2: Device pocket hematoma risk low for any anticoagulation strategy during surgery
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ANAHEIM, Calif. — Rates of device pocket hematoma were similarly low among patients who had continuation or interruption of direct oral anticoagulant therapy during surgery, according to results of the BRUISE CONTROL-2 trial presented at the American Heart Association Scientific Sessions.
According to the presentation from David H. Birnie, MD, staff cardiac electrophysiologist and director of the arrhythmia service at the University of Ottawa Heart Institute, oral anticoagulant use is common among patients who require a pacemaker or defibrillator surgery.
“Somewhere between a third and a quarter of these patients are on oral anticoagulation. We did a previous trial called BRUISE CONTROL-1 which demonstrated that if you continued warfarin at the time of device surgery, there was an 18% reduction in device pocket hematomas, but the growth of direct oral anticoagulants since that time [meant] we had to do another trial,” Birnie said. “The question really is, how to balance the risk of thromboembolism against the risk of bleeding?”
To establish a more definitive consensus on perioperative management of direct oral anticoagulants, Birnie and colleagues conducted a 662-patient, multicenter, single-blind randomized controlled trial at 15 centers in Canada and one in Israel.
The researchers hypothesized that performing device surgery without direct oral anticoagulant interruption would result in reduced rates of hematoma.
According to the presentation, when the study initially started, dabigatran (Pradaxa, Boehringer Ingelheim) was the sole direct oral anticoagulant with FDA approval, however, the approval of additional direct oral anticoagulants led to the inclusion of patients receiving apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto, Janssen).
Patients in the continuation group received anticoagulation throughout the surgical period and took a morning dose prior to surgery.
Patients in the interrupted anticoagulation cohort who were receiving rivaroxaban or apixaban ceased drug therapy after their last dose 2 days prior to surgery and those on dabigatran discontinued taking the drug at a time dependent on their glomerular filtration rate.
Twenty-four hours after surgery, all 3 drugs were resumed at the next regular dose timing.
The primary outcome was clinically significant hematoma defined as a hematoma that required re-operation, resulted in extended hospitalization or required interruption of all anticoagulation for more than 24 hours.
The Data and Safety Monitoring Board recommended early study termination at the second pre-specified analysis. All patients enrolled before this period were followed until the study was complete, Birnie said.
The researchers found no significant differences in any baseline characteristics or operative details, with the exception of intrapocket administration of prohemostatic agent and application of dressing postoperatively, both higher in the continued anticoagulation group (P = .035 for both).
According to Birnie, there was no difference in the primary outcome between the two cohorts; rates were 2.1% in both groups (P = .973), lower than expected.
There were also no differences between the groups in the individual components of the primary outcome, nor in any secondary outcomes, he said.
"Although it's a negative trial, I think it sends a very important message and a very good message to patients,” Birnie said. “Operating with continued [direct oral anticoagulants] should not be considered specifically as a strategy to reduce hematoma rate, but the take home message for clinicians is that either strategy may be reasonable depending on the clinical scenario." – by Dave Quaile
Reference:
Birnie DH, et al. LBS.01. CABG and EP Peri-procedural Dilemmas. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, California.
Disclosure: Birnie reports he receives funding from Bayer HealthCare, Boehringer Ingelheim and Bristol-Myers Squibb. The BRUISE CONTROL-2 study was funded by a grant from the Heart and Stroke Foundation of Canada.
Perspective
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Jagmeet P. Singh, MD, DPhil, FACC, FHRS
This is a landmark study. Just like BRUISE CONTROL-1, I think BRUISE CONTROL-2 is going to change practice. It shows that uninterrupted vs. interrupted direct oral anticoagulants in patients getting device surgery have a fairly comparable outcome in terms of bleeding risks or hematomas. There was a lot of contention as to how we should manage patients on direct oral anticoagulants getting device surgery. Now we know we can potentially continue the direct oral anticoagulants if a patient needs to be on one in the periprocedural period.
High-risk patients, such as those with complete heart block and those who require urgent intervention, who may be on direct oral anticoagulants no longer have to wait for their anticoagulant to wash out from their system. We can now feel more comfortable going ahead and doing the procedure in these situations, as well as in those patients that may need a cardioversion for AF in close proximity to their procedure.
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