Dyke Cornelius M, Smedira Nicholas G, Koster Andreas, Aronson Solomon, McCarthy Harry L, Kirshner Ronald, Lincoff A Michael, Spiess Bruce D
Carolina Cardiovascular and Thoracic Surgery Associates, Gaston Memorial Hospital, Gastonia, NC 28056, USA.
J Thorac Cardiovasc Surg. 2006 Mar;131(3):533-9. doi: 10.1016/j.jtcvs.2005.09.057.
Unfractionated heparin and its antidote, protamine sulfate, allow for rapid and reversible anticoagulation during cardiac surgery with cardiopulmonary bypass, yet limitations exist, including a variable dose-response, dependence on a cofactor for anticoagulant effect, and antigenic potential. This trial was performed to evaluate the safety and efficacy of bivalirudin as an alternative to heparin with protamine reversal in on-pump cardiac surgery.
We conducted a randomized, open-label, multicenter trial comparing heparin with protamine reversal to bivalirudin in patients undergoing cardiac surgery with cardiopulmonary bypass. The primary objective was to demonstrate comparable rates of in-hospital procedural success defined as freedom from death, Q-wave myocardial infarction, stroke, or repeat revascularization. Twenty-one institutions enrolled 101 patients randomized to bivalirudin and 49 patients to heparin treatment.
The primary end point of procedural success was not significantly different between the bivalirudin arm and the heparin/protamine arms at 7 days, 30 days, or 12 weeks' follow-up. Adequate anticoagulation was achieved in all patients. Secondary end points including mortality, 24-hour blood loss, overall incidence of transfusions, and duration of surgery were similar between the two arms.
Bivalirudin is a safe and effective anticoagulant for patients undergoing a wide range of cardiac surgical procedures with cardiopulmonary bypass. Procedural success rates with bivalirudin were similar to rates in patients receiving heparin anticoagulation, with no difference in mortality. Avoidance of blood stasis and attention to the intraoperative medical management of patients is critical for successful use of bivalirudin during cardiopulmonary bypass.
普通肝素及其解毒剂硫酸鱼精蛋白可在体外循环心脏手术期间实现快速且可逆的抗凝，但存在局限性，包括剂量反应可变、抗凝作用依赖辅因子以及具有抗原性。本试验旨在评估比伐卢定作为肝素替代物并使用鱼精蛋白进行逆转在体外循环心脏手术中的安全性和有效性。
我们开展了一项随机、开放标签、多中心试验，比较肝素加鱼精蛋白逆转与比伐卢定在接受体外循环心脏手术患者中的应用。主要目标是证明住院期间手术成功率相当，定义为无死亡、Q波心肌梗死、中风或再次血运重建。21家机构纳入了101例随机接受比伐卢定治疗的患者和49例接受肝素治疗的患者。
在7天、30天或12周的随访中，比伐卢定组与肝素/鱼精蛋白组在手术成功的主要终点方面无显著差异。所有患者均实现了充分抗凝。两组的次要终点包括死亡率、24小时失血量、输血总发生率和手术时长相似。
对于接受广泛体外循环心脏手术的患者，比伐卢定是一种安全有效的抗凝剂。比伐卢定的手术成功率与接受肝素抗凝的患者相似，死亡率无差异。避免血液淤滞并关注患者术中医疗管理对于体外循环期间成功使用比伐卢定至关重要。
