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

高度颈动脉狭窄的患者接受冠状动脉旁路移植术（CABG）会增加卒中和心血管并发症的风险。治疗方案包括联合同步冠脉搭桥和颈动脉内膜切除术（CEA），分阶段冠脉搭桥/颈动脉内膜切除术或颈动脉成形术合并支架植入术（CAS），或孤立冠脉搭桥。尽管许多心胸外科医生提倡联合冠脉搭桥和CEA，但这些患者的最佳手术治疗仍不清楚。事实上，似乎很少有证据证明在无症状颈动脉疾病行冠脉搭桥的患者中预防性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随机选择1160例（最少分析n=1100例）高度颈动脉狭窄的患者，分别进行单独冠脉搭桥或冠脉搭桥联合CEA。因此，在80%的功率下，可以检测到复合血管终点30天风险的绝对差异为4.5%。预先确定的亚组分析不是确认性测试的一部分，将进一步研究手术技术（特别是非泵式CABG + CEA）、狭窄程度以及性别差异。这项研究将由一个DMSB、一个执行指导委员会、一个裁决委员会和一个独立的监督机构组成，并将在大约30个德国中心进行。因此，我们相信在三年内随机抽取1160名患者是可能的。基于随机对照试验证据的预期结果将对无症状颈动脉狭窄的心血管患者的手术治疗具有重要意义。

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.