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BRUISE CONTROL: Surgery with continued warfarin reduced adverse outcomes
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DENVER — A strategy of continued warfarin during implantable cardioverter defibrillator or pacemaker surgery reduced the incidence of device-pocket hematoma compared with bridging therapy with heparin, according to results from the BRUISE CONTROL trial.
Researchers for the multicenter, single blind, controlled trial randomly assigned 688 patients at high risk for thromboembolic events undergoing implant to bridging therapy with heparin or to continued warfarin (Coumadin, Bristol-Myers Squibb).
The primary outcome — clinically significant device-pocket hematoma — was reported in 3.5% of the continued-warfarin group compared with 16% of the heparin-bridging group (RR=0.19; 95% CI, 0.1-0.36).
“Device-pocket hematomas can have serious consequences for patients, such as the need for prolonged cessation of all oral anticoagulation therapy with the attendant risk of thromboembolism, prolongation of hospitalization, the need for further surgery (eg, hematoma evaluation) and an increased risk of infection,” researchers wrote in The New England Journal of Medicine.
Major surgical and thromboembolic complications were rare and similar between the two groups (heparin-bridging group: one episode of cardiac tamponade, one MI; continued-warfarin group: one stroke, one transient ischemic attack).
“We found that operating with continued warfarin was not associated with any major bleeding event and was favored by patients,” David H. Birnie, MD, director of arrhythmia service at University of Ottawa Heart Institute, Ontario, Canada, said at a press conference. “These results suggest a continuation of warfarin during defibrillator [or pacemaker] surgery is preferable to heparin bridging.”
The BRUISE CONTROL trial was stopped early due to efficacy after the second planned interim analyses found the primary outcome of clinically significant hematoma had been achieved. – by Deb Dellapena
For more information:
Birnie DH. PO01-48. Presented at: Heart Rhythm Society’s Annual Scientific Sessions; May 8-11, 2013; Denver.
Birnie DH. N Engl J Med. 2013;doi:10.1056/NEJMoa1302946.
Disclosure: The researchers report receiving a grant from the Canadian Institute of Health Research. Birnie reports receiving grants from Sanofi-Aventis.
Perspective
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John D. Day, MD, FHRS
Ten years ago it seemed incomprehensible that you would not stop using a blood thinner during surgery. Data over the years indicate that uninterrupted oral anticoagulation, if done properly, does not have significant impact on risk, but on the benefits side the impact can be tremendous. Patients with AF no longer have to undergo surgery unprotected. In addition, during surgery, patients can be more prone to thromboembolism. From a safety standpoint, we are not seeing increased rates of bleeding.
There is a huge body of data amassing in cardiology that it is safe to implant pacemakers, ICDs and perform ablation without stopping anticoagulation. Going forward, more studies need to be done in fields outside of cardiology.
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