Efficacy and Safety of Heparinase I versus Protamine in Patients Undergoing Coronary Artery Bypass Grafting with and without Cardiopulmonary Bypass |
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Authors: | Stafford-Smith, Mark M.D. Lefrak, Edward A. M.D. Qazi, Anjum G. M.D. Welsby, Ian J. M.D.
Barber, Linda M.S.N. Hoeft, Andreas M.D.# Dorenbaum, Alejandro M.D.ast Mathias, Jasmine M.S. Rochon, James J. Ph.D. Newman, Mark F. M.D. Members of the Global Perioperative Research Organization |
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Affiliation: | Stafford-Smith, Mark M.D.*; Lefrak, Edward A. M.D.†; Qazi, Anjum G. M.D.‡; Welsby, Ian J. M.D.§; Barber, Linda M.S.N.∥; Hoeft, Andreas M.D.#; Dorenbaum, Alejandro M.D.*ast;; Mathias, Jasmine M.S.††; Rochon, James J. Ph.D.‡‡; Newman, Mark F. M.D.‡‡; Members of the Global Perioperative Research Organization |
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Abstract: | Background: Hemodynamic protamine reactions with heparin reversal during cardiac surgery are common and associated with adverse outcomes. As an alternative to protamine, the authors examined heparinase I reversal of heparin after aortocoronary bypass graft surgery. Methods: In a randomized, double-blind, double-dummy trial, 167 on- and off-pump aortocoronary bypass graft surgery patients received either heparinase I (maximum 35 [mu]g/kg) or protamine (maximum 650 mg) for heparin reversal, monitored by activated clotting time values and clinical assessment. Hemodynamic parameters were recorded electronically; safety evaluation was to 30 days postoperatively. Noninferiority was predefined as 400 ml or less median 12-h chest tube drainage from intensive care unit arrival for heparinase I patients, after risk adjustment. Hemodynamic instability was defined as systemic hypotension (>= 30 mmHg decrease) and/or pulmonary hypertension (>= 40 mmHg with an increase >= 10mmHg) within 30 min of heparin reversal initiation. Results: Patient enrollment was terminated on advisement of the Data Safety Monitoring Board. Although heparinase I was noninferior for 12-h chest tube drainage, protamine had a superior safety profile. Overall, heparinase I subjects had longer hospital stays (P = 0.04), were more likely to experience a serious adverse event (P = 0.01), and were less likely to avoid transfusion (P = 0.006). A composite morbidity score was not different (P = 0.24), and similar rates of hemodynamic instability were observed between groups. Findings were consistent in analyses stratified by on- and off-pump surgery. |
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