颈动脉狭窄支架置入术与动脉内膜切除术的长期结果
Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis.
作者信息
Brott Thomas G, Howard George, Roubin Gary S, Meschia James F, Mackey Ariane, Brooks William, Moore Wesley S, Hill Michael D, Mantese Vito A, Clark Wayne M, Timaran Carlos H, Heck Donald, Leimgruber Pierre P, Sheffet Alice J, Howard Virginia J, Chaturvedi Seemant, Lal Brajesh K, Voeks Jenifer H, Hobson Robert W
机构信息
From the Mayo Clinic, Jacksonville, FL (T.G.B., J.F.M.); the University of Alabama at Birmingham (G.H., V.J.H.) and Cardiovascular Associates of the Southeast (G.S.R.) - both in Birmingham; Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC (A.M.), and the University of Calgary, Calgary, AB (M.D.H.) - both in Canada; Baptist Health Lexington, KY (W.B.); the University of California, Los Angeles, Los Angeles (W.S.M.); Mercy Hospital St. Louis, St. Louis (V.A.M.); Oregon Health and Science University, Portland (W.M.C.); the University of Texas Southwestern Medical Center, Dallas (C.H.T); Novant Health Clinical Research, Winston-Salem, NC (D.H.); the Providence Sacred Heart Medical Center and Children's Hospital, Spokane, WA (P.P.L.); Rutgers New Jersey Medical School, Newark (A.J.S., R.W.H.); the University of Miami Miller School of Medicine, Miami (S.C.); the University of Maryland Medical Center, Baltimore (B.K.L.); and the Medical University of South Carolina, Charleston (J.H.V.).
出版信息
N Engl J Med. 2016 Mar 17;374(11):1021-31. doi: 10.1056/NEJMoa1505215. Epub 2016 Feb 18.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
背景
在颈动脉血运重建内膜切除术与支架置入术试验中，我们发现支架置入组和内膜切除术组在围手术期的主要复合终点（卒中、心肌梗死或死亡）以及4年随访期内任何随后的同侧卒中方面无显著差异。我们现在将结果扩展至10年。
方法
在随机分配接受支架置入术或内膜切除术的颈动脉狭窄患者中，我们在117个中心每6个月评估一次结局，最长达10年。除了评估主要复合终点外，我们还评估了长期扩展研究的主要终点，即围手术期后的同侧卒中。
结果
在2502例患者中，支架置入组（11.8%；95%置信区间[CI]，9.1至14.8）和内膜切除术组（9.9%；95%CI，7.9至12.2）在10年随访期内主要复合终点发生率无显著差异（风险比，1.10；95%CI，0.83至1.44）。关于主要长期终点，在10年随访期内，支架置入组6.9%（95%CI，4.4至9.7）的患者发生术后同侧卒中，内膜切除术组为5.6%（95%CI，3.7至7.6）；两组发生率无显著差异（风险比，0.99；95%CI，0.64至1.52）。对有症状患者和无症状患者分别进行分析时，两组在任一终点方面均未检测到显著差异。
结论
经过10年随访，我们发现接受支架置入术的患者和接受内膜切除术的患者在围手术期卒中、心肌梗死或死亡风险以及随后同侧卒中风险方面无显著差异。两组术后同侧卒中发生率也无差异。（由美国国立卫生研究院和雅培血管解决方案公司资助；CREST临床试验.gov编号，NCT00004732。）
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