![]() Of note, this was a study restricted to patients at high stroke risk – greater than 5% annually – as defined by the presence of atrial fibrillation and a CHADS 2 score of 3 or more or the presence of a mechanical heart valve.ĭr. ![]() However, the Data and Safety Monitoring Board halted the study after an interim analysis involving the first 681 subjects. And patient satisfaction surveys indicated subjects greatly preferred having their procedure without stopping their warfarin.īRUISE CONTROL was planned as a definitive 1,000-patient clinical trial. Performing device surgery in patients on uninterrupted warfarin with a median international normalized ratio (INR) of 2.3 was not associated with any increase in major perioperative bleeding or other surgical or thromboembolic complications. All three components of the primary endpoint were significantly less frequent in the uninterrupted warfarin group (see chart). Clinically significant device-pocket hematoma was defined in this trial as a hematoma resulting in prolonged hospitalization for an additional day or more, or interruption of oral anticoagulation for at least 24 hours, and/or requiring additional surgery. It is quite painful, can cause device infection, and is difficult to treat. "For sure, our clinical practice changed as soon as we saw those results."ĭevice-pocket hematoma is a "very nasty" complication of cardiac device surgery, Dr. It was unequivocally positive," he commented. Birnie of the University of Ottawa Heart Institute. ![]() It is recommended in this common clinical scenario in all of the major guidelines, but that’s bound to change as a result of BRUISE CONTROL, predicted Dr. Heparin bridging has been the standard of care. These results are clearly practice changing. ![]()
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