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Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis (CABACS): a randomized controlled trial

无症状颈动脉狭窄 (CABACS) 患者的冠状动脉搭桥手术：一项随机对照试验

基本信息

批准号：
128961729
负责人：
Professor Dr. Christian Weimar
金额：
--
依托单位：
Klinik für Neurologie
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2010
资助国家：
德国
起止时间：
2009-12-31 至 2014-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/128961729?language=en
关键词：
Coronary Artery Bypass graft surgery

项目摘要

Patients with high-grade carotid stenosis undergoing coronary artery bypass graft (CABG) surgery have an increased risk of stroke and cardiovascular complications. Treatment options include combined synchronous CABG and carotid endarterectomy (CEA), staged CABG / CEA or carotid angioplasty with stenting (CAS), or isolated CABG. Although combined CABG and CEA is advocated by many cardiothoracic surgeons, optimal surgical management in these patients remains unknown. In fact, there seems to be little evidence to justify prophylactic CEA or CAS in patients with asymptomatic carotid disease undergoing CABG. This multidisciplinay trial of cardiothoracic surgeons and neurologists aims to randomize 1,160 patients (minimum to be analyzed n=1100) with high-grade carotid stenosis to either isolated CABG or combined CABG and CEA. Thus, a 4.5% absolute difference in the 30-day risk of the composite vascular endpoint can be detected with 80% power. Predefined subgroup analyses which are not part of the confirmatory testing will furthermore investigate operative techniques (in particular off-pump CABG + CEA), degree of stenosis as well as gender differences. The study will have a DMSB, an executive steering committee, an adjudication committee and an independent monitoring and will be performed in about 30 German centers. Thus, we believe that it will be possible to randomize 1,160 patients within three years. The expected results based on randomized controlled trial evidence will be of major importance for surgical management in cardiovascular patients with asymptomatic carotid stenosis.

接受冠状动脉旁路移植术（CABG）的高度颈动脉狭窄患者发生卒中和心血管并发症的风险增加。治疗选择包括联合同步CABG和颈动脉内膜切除术（CEA），分期CABG / CEA或颈动脉血管成形术与支架植入术（CAS），或单独CABG。尽管许多心胸外科医生提倡联合CABG和CEA，但这些患者的最佳手术治疗仍然未知。事实上，似乎很少有证据证明在接受CABG的无症状颈动脉疾病患者中预防性CEA或CAS是合理的。这项由心胸外科医生和神经科医生参与的多学科试验旨在将1，160名患有高度颈动脉狭窄的患者（最少分析n=1100）随机分为单独CABG组或CABG和CEA联合组。因此，在80%的把握度下，可以检测到复合血管终点的30天风险的4.5%绝对差异。不属于确证性试验的预定义亚组分析将进一步研究手术技术（特别是非体外循环CABG + CEA）、狭窄程度以及性别差异。该研究将由DMSB、执行指导委员会、裁定委员会和独立监查委员会组成，并将在约30家德国中心进行。因此，我们相信有可能在三年内对1,160名患者进行随机分组。基于随机对照试验证据的预期结果对于无症状颈动脉狭窄的心血管患者的外科治疗具有重要意义。