Continuous or interrupted DOACs during device surgery yields similar hematoma incidence
The incidence of clinically significant hematoma is similar in individuals with atrial fibrillation undergoing pacemaker or defibrillator surgery regardless of whether their direct oral anticoagulants (DOACs) are continued or interrupted perioperatively, results of the BRUISE CONTROL-2* trial show.
“The bottom line is that there was no difference between the two strategies and in both arms the event rate of device hematoma was extremely low. That’s good news for patients,” said study author Dr David Birnie from the University of Ottawa Heart Institute, Ottawa, Canada, who presented the findings at the American Heart Association (AHA) 2017 Scientific Sessions.
In this multicentre, single-blind trial, patients with atrial fibrillation and CHA2DS2-VASc score ≥2 (mean score 3.9) treated with dabigatran, rivaroxaban, or apixaban were randomized to receive either continuous (n=328, mean age 74.1 years, 74.7 percent male) or interrupted (n=334, mean age 73.4 years, 70.1 percent male) doses of their DOACs at time of pacemaker or defibrillator surgery. Those randomized to the interrupted group resumed DOACs ≥24 hours post-surgery.
Incidence of hematoma requiring re-operation, prolonged hospitalization, and/or anticoagulation cessation for >24 hours was comparable between patients whose DOACs were continued and interrupted (2.1 percent in each group; p=0.973). [AHA 2017, LBS.01]
The incidence of non-clinically significant hematoma also occurred at comparable rates between patients on continued and interrupted DOACs (3.4 percent vs 3.0 percent), while other secondary outcomes such as stroke, cardiac tamponade, and all-cause mortality were low in number and comparable between the two groups.
“BRUISE CONTROL-1 was very definitive that you continue warfarin for device surgery ... it can really reduce bleeding as opposed to heparin bridging. We didn’t know how the DOACs would compare,” said Birnie, on the reason behind the trial. [N Engl J Med 2013;368:2084-2093]
“There is uncertainty about how DOACs should be managed perioperatively around device surgery to balance the risks of thromboembolism and perioperative bleeding. Experience from the major DOAC clinical trials found that brief, temporary interruptions for procedures or surgery are associated with an approximately threefold increase in stroke or systemic embolism,” he said.
“On the other hand, device pocket hematomas … can necessitate prolonged cessation of anticoagulation which increases the risk of thromboembolism and is associated with a markedly increased risk of serious device system infection.”
“[The results of this trial show that] operating with continued DOAC should not be considered specifically as a strategy to reduce hematoma rate … either strategy may be reasonable depending on clinical scenario,” he said.
“For example, [if] a patient’s at very high risk of stroke, then it’s quite reasonable to do the operation without stopping the DOAC or just stopping it for one dose. And if a patient’s [at] much lower risk of stroke, then the risk-benefit ratio is different … it’s quite reasonable to temporarily stop it for three or four days and do the operation without [DOACs],” concluded Birnie.