Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis.

Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis.
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DOI:
10.1056/nejmoa1505215
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发表时间:
2016-03-17
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
CREST Investigators
CREST Investigators
中科院分区:
其他
文献类型:
--
作者:
Brott TG;Howard G;Roubin GS;Meschia JF;Mackey A;Brooks W;Moore WS;Hill MD;Mantese VA;Clark WM;Timaran CH;Heck D;Leimgruber PP;Sheffet AJ;Howard VJ;Chaturvedi S;Lal BK;Voeks JH;Hobson RW 2nd;CREST Investigators

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在颈动脉内膜切除术与支架植入术的对比试验中,我们发现支架植入组和动脉内膜剥脱组在4年的随访期内或随后的任何同侧卒中中,在卒中、心肌梗死或死亡的主要复合终点方面没有显著差异。我们现在将结果扩展到10年。在被随机分配到支架植入术或动脉内膜切除术的颈动脉狭窄患者中,我们在117个中心进行了长达10年的每6个月一次的结果评估。除了评估主要的复合终点外,我们还评估了长期延伸研究的主要终点,即围术期后的同侧卒中。在2502名患者中,在10年随访(风险比1.10;95%可信区间0.83至1.44)中,支架组(11.8%;95%可信区间[CI]9.1至14.8)和动脉内膜切除术组(9.9%;95%可信区间(7.9至12.2))之间的初级复合终点发生率无显著差异。就主要的长期终点而言,术后10年随访的同侧中风发生率,支架组为6.9%(95%CI,4.4~9.7),动脉内膜切除术组为5.6%(95%CI,3.7~7.6),两组间无显著差异(危险比0.99;95%CI,0.64~1.52)。当分别分析有症状患者和无症状患者时,没有发现两组之间在任何一个终点上的显著差异。经过10年的随访,我们没有发现接受支架置入术的患者和接受动脉内膜切除术的患者在围手术期卒中、心肌梗死或死亡和随后的同侧卒中的风险方面没有显著差异。术后同侧卒中的发生率在不同组之间也没有差异。(由国立卫生研究院和雅培血管解决方案公司资助;CREST ClinicalTrials.gov编号,NCT00004732。)
In the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. Among patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. Among 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately. Over 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.)