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On-Pump Versus Off-Pump Coronary Artery Bypass Surgery in Elderly Patients:Results From the Danish On-Pump Versus Off-Pump Randomization Study

机译：老年患者的泵上与泵外冠状动脉搭桥手术：丹麦泵上与泵外随机研究的结果

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BACKGROUND: Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially in elderly patients. METHODS AND RESULTS: In a multicenter, randomized trial, we assigned 900 patients 70 years of age to conventional coronary artery bypass grafting or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined end point of death, stroke, or myocardial infarction had occurred. At baseline and 6 months postoperatively, self-assessed quality of life was measured with the Medical Outcomes Study Short Form-36 and EuroQol-5D questionnaires. A 6-month follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined end point within 30 days was 10.2% for conventional coronary artery bypass grafting and 10.7% for OPCAB. Implied risk difference of 0.4% (with a 95% confidence interval, -3.6 to 4.4) showed nonsignificance in a standard test for equality (P=0.83) and for noninferiority with an inferiority margin of 0.5% (P=0.49). At the 6-month follow-up, mortality was 4.7% compared with 4.2% (P=0.75). Both groups showed significant improvement in self-assessed health-related quality of life. CONCLUSIONS: Both conventional coronary artery bypass grafting and OPCAB are safe procedures that improved the quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However, the noninferiority of OPCAB with the prespecified margin could not be confirmed. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00123981.
机译：背景：使用体外循环进行的常规冠状动脉搭桥术对于缺血性心脏病患者是一种经过充分验证的治疗方法。已提出非体外循环冠状动脉搭桥术（OPCAB）可以减少围手术期并发症的数量，尤其是在老年患者中。方法和结果：在一项多中心随机试验中，我们将900名年龄大于70岁的患者分配到常规冠状动脉搭桥术或OPCAB手术中。 30天后，一个盲目的终点委员会评估了是否发生了死亡，中风或心肌梗死的综合终点。在基线和术后6个月，使用Medical Outcomes Study Short Form-36和EuroQol-5D问卷测量自我评估的生活质量。通过丹麦国家登记处对死亡率进行了6个月的随访。传统冠状动脉搭桥术在30天内经历合并终点的患者比例为10.2％，OPCAB为10.7％。隐含的风险差异为0.4％（置信区间为95％，从-3.6到4.4），在标准测试中对平等性（P = 0.83）和非劣效性的下等标准为0.5％（P = 0.49），这没有意义。在6个月的随访中，死亡率为4.7％，而同期为4.2％（P = 0.75）。两组都显示出自我评估的健康相关生活质量的显着改善。结论：常规冠状动脉搭桥术和OPCAB都是安全的方法，可以改善老年患者的生活质量。未发现中期结局有重大差异。但是，无法确认OPCAB具有预定余量的非劣质性。临床试验注册：URL：http://www.clinicaltrials.gov。唯一标识符：NCT00123981。

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