Robarts Research Institute, University of Western Ontario, London, ON, Canada.
Int J Stroke. 2010 Dec;5(6):455-6. doi: 10.1111/j.1747-4949.2010.00532.x.
Carotid angioplasty and stenting has become a popular alternative to carotid endarterectomy for the treatment of carotid stenosis in stroke. Evidence from early randomized controlled trials comparing these interventions revealed mixed results. The largest such trial, the Carotid Revascularization Endarterectomy vs. Stenting Trial recently showed equivalence of the procedures in a mixed cohort of both symptomatic and asymptomatic patients. These results have been heralded in North America as definitively demonstrating the safety and efficacy of carotid angioplasty and stenting, making it an attractive alternative to carotid endarterectomy. It is therefore probable that many more asymptomatic patients will be subjected to Carotid angioplasty and stenting, perceived by many to be less invasive than carotid endarterectomy. The authors argue that the design of Carotid Revascularization Endarterectomy vs. Stenting Trial was flawed by the mixture of two dissimilar patient groups, thus violating the principle of ceteris paribus, essential for the validity of a randomized controlled trials. The evidence for any invasive treatment of asymptomatic carotid disease is weak, with recent data favouring purely medical management. The authors believe that carotid angioplasty and stenting in asymptomatic patients should cease until better evidence is available.
颈动脉血管成形术和支架置入术已成为治疗中风颈动脉狭窄的一种替代颈动脉内膜切除术的热门方法。来自早期随机对照试验比较这些干预措施的证据显示出混合结果。最近,最大规模的此类试验颈动脉血管重建内膜切除术与支架置入术试验在混合队列的有症状和无症状患者中显示出这些手术的等效性。这些结果在北美被欢呼为明确证明了颈动脉血管成形术和支架置入术的安全性和有效性,使其成为颈动脉内膜切除术的一个有吸引力的替代方法。因此,很可能会有更多的无症状患者接受颈动脉血管成形术和支架置入术,因为许多人认为它比颈动脉内膜切除术侵入性更小。作者认为,颈动脉血管重建内膜切除术与支架置入术试验的设计存在缺陷,因为混合了两组截然不同的患者群体,从而违反了随机对照试验有效性的一个重要原则——“其他条件相同”。任何针对无症状颈动脉疾病的侵入性治疗的证据都很薄弱,最近的数据支持单纯的药物治疗。作者认为,在有更好的证据之前,应停止对无症状患者进行颈动脉血管成形术和支架置入术。