Randomized comparison of synchronous CABG and carotid endarterectomy vs. isolated CABG in patients with asymptomatic carotid stenosis: The CABACS trial
Randomized comparison of synchronous CABG and carotid endarterectomy vs. isolated CABG in patients with asymptomatic carotid stenosis: The CABACS trial
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DOI：
10.1111/j.1747-4949.2011.00687.x
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发表时间：
2012-06-01
影响因子：
6.7
通讯作者：
Weimar, C.
中科院分区：
文献类型：
--
作者：
Knipp, S. C.;Scherag, A.;Weimar, C.
68%接受冠状动脉旁路移植术的患者存在高度颈动脉狭窄。许多心血管外科医生提倡分期或同步颈动脉内膜切除术，以降低与多支血管疾病相关的高围手术期和长期卒中风险。然而，没有随机试验评估联合同步或分期颈动脉内膜切除术是否比单纯冠状动脉旁路移植术对这些患者有任何益处。目的：本研究的目的是比较单纯冠状动脉旁路移植术与同步冠状动脉旁路移植术和颈动脉内膜切除术在无症状高度颈动脉狭窄患者中的安全性和有效性。设计无症状颈动脉狭窄患者的冠状动脉旁路移植术（CABACS）是一项随机、对照、开放、多中心、分组序贯试验，有两个平行组，结果由设盲观察者裁定。计划进行择期冠状动脉旁路移植术的无症状高度颈动脉狭窄患者将按照1？：？的比例被分配接受单纯冠状动脉旁路移植术或同步冠状动脉旁路移植术和颈动脉内膜切除术。采用3种不同分层因素（年龄、性别、改良兰金量表）进行1次区组分层随机化。该试验于2010年12月开始，旨在招募25至30个德国心血管中心的1160名患者。复合主要疗效终点是术后30天内中风和任何原因导致的死亡（无论先发生的是什么）的数量。上述终点的30天发生率的绝对差异为4.5%（4%与8.5%），可以检测到>80%的把握度。该试验的结果有望为定义循证标准提供基础，并将对管理这种疾病产生广泛影响。
Rationale High-grade carotid artery stenosis is present in 68% of patients undergoing coronary artery bypass graft surgery. Many cardiovascular surgeons advocate staged or synchronous carotid endarterectomy to reduce the high perioperative and long-term risk of stroke associated with multivessel disease. However, no randomized trial has assessed whether a combined synchronous or staged carotid endarterectomy confers any benefit compared with isolated coronary artery bypass grafting in these patients. Aims The objective of this study is to compare the safety and efficacy of isolated coronary artery bypass grafting vs. synchronous coronary artery bypass grafting and carotid endarterectomy in patients with asymptomatic high-grade carotid artery stenosis. Design Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis (CABACS) is a randomized, controlled, open, multicenter, group sequential trial with two parallel arms and outcome adjudication by blinded observers. Patients with asymptomatic high-grade carotid stenosis scheduled for elective coronary artery bypass grafting will be assigned to either isolated coronary artery bypass grafting or synchronous coronary artery bypass grafting and carotid endarterectomy by 1?:?1 block-stratified randomization with three different stratification factors (age, gender, modified Rankin scale). Study The trial started in December 2010 aiming at recruiting 1160 patients in 25 to 30 German cardiovascular centers. The composite primary efficacy end point is the number of strokes and deaths from any cause (whatever occurs first) within 30 days after operation. A 4.5% absolute difference (4% compared to 8.5%) in the 30-day rate of the above end points can be detected with >80% power. Outcomes The results of this trial are expected to provide a basis for defining an evidence-based standard and will have a wide impact on managing this disease.