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DENVER, CO — Patients at aerial accident of thromboembolism who crave pacemaker or implantable cardioverter-defibrillator (ICD) anaplasty can cautiously abide onwarfarin, after interruption, rather than be bridged with heparin, after-effects of the BRUISE CONTROL abstraction suggest[1].
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Dr David H Birnie (Ottawa Heart Institute, ON) and colleagues address their allegation online May 9, 2013 in the New England Journal of Medicine, timedto accompany with Birnie's presentation of the abstraction at the Heart Rhythm Society (HRS) 2013 Scientific Sessions .
Guidelines currently acclaim that patients at aerial accident for thromboembolic contest be bridged with heparin therapy, with their warfarin chock-full bristles canicule afore their procedure, the accumulation notes. But few randomized, controlled studies accept absolutely accustomed the activity a able test, abnormally compared with artlessly advancement patients on warfarin throughout their procedures.
In BRUISE CONTROL's >600 patients who at baseline had a predicted anniversary achievement accident of >5%, the continued-warfarin access was associated with a "highly cogent abridgement in the amount of device-pocket hematoma compared with heparin bridging," Birnie acclaimed back formally presenting the balloon at the HRS sessions. The accident of that primary end point was bargain by 81% (p<0.001).
"We additionally begin that operating with connected warfarin, with a average [international normalized ratio] INR of 2.3, was not associated with any above perioperative bleeding events," he said.
At a columnist appointment on the trial, Birnie empiric that all the apparatus of the primary end point, which reflected altered kinds of abridged hematoma, were decidedly bargain in the continued-warfarin group. "So the abstraction was absolutely positive."
Reporters asked Birnie whether the trial's allegation in patients who took warfarin or, if bridged, low-molecular-weight heparin or unfractionated heparin, could be extrapolated to surgery-scheduled patients who are on dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto, Bayer/Johnson & Johnson), or apixaban (Eliquis, Bristol-Myers Squibb/Pfizer).
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"This does not in any way administer to the new agents," he said. "The accomplished risk/benefit arrangement with the new agents is absolutely altered from [that of] warfarin. Their access of activity is in hours as adjoin to bristles days."
The balloon had randomized 338 patients to heparin bridging and 343 to warfarin assiduity by the time the abstracts assurance ecology lath recommended aboriginal termination. A additional prespecified acting assay appropriate a cogent advantage for warfarin continuation. The amount of clinically accordant abridged hematoma was 16% in the heparin-bridging accumulation and alone 3.5% in the continued-warfarin accumulation (p<0.001).
Relative Accident (RR) for Outcomes, Connected Warfarin (N=343) vs Heparin Bridging (n=338)
Dr David H Birnie
Major surgical and thrombotic complications were few, with no cogent differences amid assay groups.
Moreover, Birnie empiric in his presentation, "patients in the continued- warfarin arm had abundant greater achievement with their perioperative anticoagulation management." That was reflected in their college array on the seven-point Likert scale, which averaged 6.4 in adverse to 5.9 for patients in the heparin-bridging accumulation (p<0.001).
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After Birnie's presentation, affair comoderator Dr John D Day (Intermountain Medical Center, Salt Lake City, UT) asked him whether the balloon has afflicted convenance at his center. He additionally asked what added influences on outcomes were observed.
"For sure, our analytic convenance afflicted as anon as we saw these results," Birnie replied. And "there were alone three absolute predictors of pocket-hematoma accumulation in multivariate analysis. Number one, and far and abroad the best important, was to do it on connected warfarin. Number two, aspirin angled the accident of abridged hematoma. Number three, a aftereffect that was a abruptness to us: the attendance of diabetes seemed to be careful adjoin abridged hematoma."
Birnie's academy has accustomed grants from the Canadian Institute of Health Research; he has accustomed grants from Sanofi. Disclosures for the coauthors are accessible at nejm.org.
Heartwire from Medscape © 2013 Medscape, LLC
Cite this article: BRUISE CONTROL: Connected Warfarin Beats Heparin Bridging in ICD/Pacemaker Implants - Medscape - May 12, 2013.
Steve Stiles is a announcer for theheart.org. He has been advertisement on cardiovascular anesthetic back 1984 and for the accomplished 3 years has been a announcer for theheart.org, allotment of the WebMD Professional Network. Steve is a alum of Kenyon College and has an MS from the journalism administration at Boston University. He can be contacted at SStiles@webmd.net.
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Disclosure: Steve Stiles has appear no accordant banking relationships.
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Dr John D Day
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