A comparison of bivalirudin to heparin with protamine reversal in patients undergoing cardiac surgery with cardiopulmonary bypass: The EVOLUTION-ON study
A comparison of bivalirudin to heparin with protamine reversal in patients undergoing cardiac surgery with cardiopulmonary bypass: The EVOLUTION-ON study
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DOI：
10.1016/j.jtcvs.2005.09.057
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发表时间：
2006-03-01
影响因子：
6
通讯作者：
Spiess, BD
中科院分区：
文献类型：
--
作者：
Dyke, CM;Smedira, NG;Spiess, BD
目的：普通肝素及其解毒剂硫酸鱼精蛋白可在心肺转流心脏手术期间进行快速和可逆的抗凝，但存在局限性，包括可变的剂量反应、对抗凝作用辅因子的依赖性和抗原潜力。本试验是为了评估比伐卢定的安全性和有效性的替代肝素鱼精蛋白逆转在on-pump cardiac surgery.Methods：我们进行了一项随机，开放标签，多中心试验比较肝素鱼精蛋白逆转比伐卢定在接受心脏手术与心肺转流术的患者。主要目的是证明院内手术成功率相当，定义为无死亡、Q波心肌梗死、卒中或重复血运重建。21个机构招募了101例患者随机接受比伐卢定和49例患者肝素treatment.Results：在7天，30天或12周的随访中，比伐卢定组和肝素/鱼精蛋白组之间的手术成功的主要终点没有显著差异。所有患者均获得充分抗凝。次要终点，包括死亡率，24小时失血量，输血的总发生率，手术的持续时间是相似的两个arms.Conclusions：比伐卢定是一种安全有效的抗凝剂，为患者进行了广泛的心脏外科手术与体外循环。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。避免血液淤滞和注意患者的术中医疗管理对于在体外循环期间成功使用比伐卢定至关重要。
Objectives: 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.Methods: 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.Results: 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.Conclusions: 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.