Continuing NOACs During Device Surgery Does Not Reduce Pocket Hematoma

ANAHEIM, CA—For patients who are taking a non-vitamin K antagonist oral anticoagulant (NOAC) and require device surgery, it does not make a difference whether anticoagulation is interrupted or continued, the BRUISE CONTROL-2 trial suggests.

The rate of clinically significant pocket hematoma was 2.1% using either strategy (P = 0.973) among patients undergoing pacemaker or implantable cardioverter-defibrillator (ICD) surgery, according to David Birnie, MD (University of Ottawa Heart Institute, Canada).

Secondary outcomes, including ischemic stroke, did not differ between groups either, he reported at the American Heart Association 2017 Scientific Sessions.

“Operating with continued [NOAC use] should not be considered specifically as a strategy to reduce hematoma rate,” he said at a press conference. “But I think the take-home message for clinicians is that either strategy may be reasonable depending on the clinical scenario.”

He said clinicians might opt to continue anticoagulation when the risk of stroke is extremely high—in patients who just underwent ablation for A-fib or who might undergo cardioversion at the same time as device implantation, for example. On the other hand, if the stroke risk is low, then patients and physicians may prefer brief interruptions of NOAC therapy, he added.

Birnie explained that physicians often must decide what to do with anticoagulated patients, who represent roughly one-quarter to one-third of those undergoing device surgery. The original BRUISE CONTROL trial showed that among warfarin-treated patients, continuing anticoagulation versus interrupting and bridging with heparin reduced pocket hematomas by 80%.

The emergence of NOACs has resulted in the need for another trial, however, because there remains uncertainty about how to manage treatment around the time of device surgery to best balance the risks of thromboembolism and bleeding. Data from the major NOAC trials indicate that even brief interruptions of treatment increase the risk of stroke or systemic embolism, but bleeding complications—including pocket hematomas—can have important consequences as well, Birnie said, pointing to serious device-system infections.

Designed to evaluate approaches to perioperative NOAC management, BRUISE CONTROL-2, conducted at 15 centers in Canada and one in Israel, randomized patients with a CHA2DS2-VASc score of 2 or higher who were undergoing pacemaker or ICD surgery to continue NOAC therapy throughout the surgical period or interrupt treatment. In the interrupted group, patients taking rivaroxaban (Xarelto; Bayer/Janssen) or apixaban (Eliquis; Bristol-Myers Squibb) stopped treatment 2 days before surgery, whereas those taking dabigatran (Pradaxa; Boehringer Ingelheim) stopped at an interval that depended on their renal function. Treatment was then restarted at least 24 hours after surgery.

The researchers planned to enroll 846 patients, but the data and safety monitoring board recommended stopping the trial after the second prespecified interim analysis. Thus, the trial involved 662 patients, who had an average CHA2DS2-VASc score of 3.9. NOAC treatment was split relatively evenly among dabigatran, rivaroxaban, and apixaban.

The primary outcome was clinically significant hematomas, defined as those requiring reoperation, resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation for more than 24 hours. None of those differed between the continued and interrupted groups.

Secondary outcomes also occurred at similar rates in both arms. Of note, there was only one ischemic stroke in each group.

‘Best Outcome We Could Have Hoped for’

Mina Chung, MD (Cleveland Clinic, OH), who served as a discussant following Birnie’s presentation, congratulated the investigators “for really filling a void in our knowledge base and helping us to know what to do with our anticoagulation patients. Although it may be viewed as a negative study, this is probably the best outcome that we could have hoped for.”

Combined, BRUISE CONTROL and BRUISE CONTROL-2 indicate that “continued warfarin is preferred over interruption with heparin bridging in avoiding hematomas, and either continued or interrupted NOACs are acceptable for [cardiovascular implantable electronic device] procedures because there’s no increase in [stroke] or TIA with interrupted NOACs and no increase in clinically significant hematomas [with continued NOACs],” she said.

In addition, she said, BRUISE CONTROL-2 validated the approach to interrupting NOACs.

Looking to broader implications, Chung said bridging might still be advisable for some warfarin-treated patients with high thromboembolic risk, such as those with mechanical prosthetic valves or those who have had recent events.

As for NOACs, BRUISE CONTROL-2 suggests that withholding therapy for short periods of time might be used for other surgical procedures, she said. She noted, however, that certain patients, including those with low renal function, active device infection or a need for lead extraction, and rheumatic heart disease, were not included in the trial population.