From the Department of Neurology and Stroke Center (M.D.M., L.H.B.), University Hospital Basel, University of Basel, Switzerland.
Department of Clinical Research, Clinical Trial Unit (S.v.F.), University Hospital Basel, University of Basel, Switzerland.
Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.
Background and Purpose- Stenting for symptomatic carotid stenosis (carotid artery stenting [CAS]) carries a higher risk of procedural stroke or death than carotid endarterectomy (CEA). It is unclear whether this extra risk is present both on the day of procedure and within 1 to 30 days thereafter and whether clinical risk factors differ between these periods. Methods- We analyzed the risk of stroke or death occurring on the day of procedure (immediate procedural events) and within 1 to 30 days thereafter (delayed procedural events) in 4597 individual patients with symptomatic carotid stenosis who underwent CAS (n=2326) or CEA (n=2271) in 4 randomized trials. Results- Compared with CEA, patients treated with CAS were at greater risk for immediate procedural events (110 versus 42; 4.7% versus 1.9%; odds ratio, 2.6; 95% CI, 1.9-3.8) but not for delayed procedural events (59 versus 46; 2.5% versus 2.0%; odds ratio, 1.3; 95% CI, 0.9-1.9; interaction P=0.006). In patients treated with CAS, age increased the risk for both immediate and delayed events while qualifying event severity only increased the risk of delayed events. In patients treated with CEA, we found no risk factors for immediate events while a higher level of disability at baseline and known history of hypertension were associated with delayed procedural events. Conclusions- The increased procedural stroke or death risk associated with CAS compared with CEA was caused by an excess of events occurring on the day of procedure. This finding demonstrates the need to enhance the procedural safety of CAS by technical improvements of the procedure and increased operator skill. Higher age increased the risk for both immediate and delayed procedural events in CAS, mechanisms of which remain to be elucidated. Clinical Trial Registration- URL: https://clinicaltrials.gov . Unique identifier: NCT00190398. URL: http://www.isrctn.com . Unique identifier: ISRCTN57874028. URL: http://www.isrctn.com . Unique identifier: ISRCTN25337470. URL: https://clinicaltrials.gov . Unique identifier: NCT00004732.
背景与目的-与颈动脉内膜切除术（CEA）相比，症状性颈动脉狭窄的支架置入术（颈动脉支架置入术 [CAS]）具有更高的程序内卒中或死亡风险。目前尚不清楚这种额外的风险是否存在于手术当天以及随后的 1 至 30 天内，并且在这些时间段内是否存在不同的临床危险因素。方法-我们分析了 4597 例症状性颈动脉狭窄患者（行 CAS 治疗者 2326 例，行 CEA 治疗者 2271 例）在 4 项随机试验中接受 CAS（n=2326）或 CEA（n=2271）后的手术当天（即刻手术事件）和术后 1 至 30 天（延迟手术事件）发生卒中或死亡的风险。结果-与 CEA 相比，行 CAS 治疗的患者更易发生即刻手术事件（110 例 vs 42 例；4.7% vs 1.9%；比值比，2.6；95%可信区间，1.9-3.8），但不易发生延迟手术事件（59 例 vs 46 例；2.5% vs 2.0%；比值比，1.3；95%可信区间，0.9-1.9；交互 P=0.006）。在接受 CAS 治疗的患者中，年龄增加了即刻和延迟事件的风险，而 qualifying event 严重程度仅增加了延迟事件的风险。在接受 CEA 治疗的患者中，我们未发现即刻事件的危险因素，而基线时残疾程度较高和已知高血压病史与延迟手术事件相关。结论-与 CEA 相比，CAS 引起的手术相关卒中或死亡风险增加归因于手术当天发生的事件过多。这一发现表明，需要通过手术技术改进和提高操作人员技能来提高 CAS 的手术安全性。在 CAS 中，较高的年龄增加了即刻和延迟手术事件的风险，其机制仍有待阐明。临床试验注册- URL：https://clinicaltrials.gov。唯一标识符：NCT00190398。URL：http://www.isrctn.com。唯一标识符：ISRCTN57874028。URL：http://www.isrctn.com。唯一标识符：ISRCTN25337470。URL：https://clinicaltrials.gov。唯一标识符：NCT00004732。
