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在颈动脉血管重建内膜切除术与支架置入术试验中,封堵对减少再狭窄的影响。

Effect of patching on reducing restenosis in the carotid revascularization endarterectomy versus stenting trial.

作者信息

Malas Mahmoud, Glebova Natalia O, Hughes Susan E, Voeks Jenifer H, Qazi Umair, Moore Wesley S, Lal Brajesh K, Howard George, Llinas Rafael, Brott Thomas G

机构信息

From the Department of Vascular and Endovascular Surgery, Johns Hopkins University, Baltimore, MD (M.M., U.Q., R.L.); Department of Surgery, University of Colorado Denver, Aurora (N.O.G.); Department of Surgery, New Jersey Medical School, Rutgers University, Newark (S.E.H.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Surgery, University of California Los Angeles Medical Center (W.S.M.); Department of Surgery, University of Maryland Medical Center, Baltimore (B.K.L.); Department of Biostatistics, University of Alabama at Birmingham (G.H.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).

出版信息

Stroke. 2015 Mar;46(3):757-61. doi: 10.1161/STROKEAHA.114.007634. Epub 2015 Jan 22.

Abstract

BACKGROUND AND PURPOSE

The purpose is to determine whether patching during carotid endarterectomy (CEA) affects the perioperative and long-term risks of restenosis, stroke, death, and myocardial infarction as compared with primary closure.

METHODS

We identified all patients who were randomized and underwent CEA in Carotid Revascularization Endarterectomy versus Stenting Trial. CEA patients who received a patch were compared with patients who underwent CEA with primary closure without a patch. We compared periprocedural and 4-year event rates, 2-year restenosis rates, and rates of reoperation between the 2 groups. We further analyzed results by surgeon specialty.

RESULTS

There were 1151 patients who underwent CEA (753 [65%] with patch and 329 [29%] with primary closure). We excluded 44 patients who underwent eversion CEA and 25 patients missing CEA data (5%). Patch use differed by surgeon specialty: 89% of vascular surgeons, 6% of neurosurgeons, and 76% of thoracic surgeons patched. Comparing patients who received a patch versus those who did not, there was a significant reduction in the 2-year risk of restenosis, and this persisted after adjustment by surgeon specialty (hazard ratio, 0.35; 95% confidence interval, 0.16-0.74; P=0.006). There were no significant differences in the rates of periprocedural stroke and death (hazard ratio, 1.58; 95% confidence interval, 0.33-7.58; P=0.57), in immediate reoperation (hazard ratio, 0.6; 95% confidence interval, 0.16-2.27; P=0.45), or in the 4-year risk of ipsilateral stroke (hazard ratio, 1.23; 95% confidence interval, 0.42-3.63; P=0.71).

CONCLUSIONS

Patch closure in CEA is associated with reduction in restenosis although it is not associated with improved clinical outcomes. Thus, more widespread use of patching should be considered to improve long-term durability.

CLINICAL TRIAL REGISTRATION URL

http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

摘要

背景与目的

目的是确定与一期缝合相比,颈动脉内膜切除术(CEA)中使用补片是否会影响围手术期及再狭窄、中风、死亡和心肌梗死的长期风险。

方法

我们在颈动脉血运重建内膜切除术与支架置入术试验中确定了所有随机分组并接受CEA的患者。将接受补片的CEA患者与接受一期缝合且未使用补片的CEA患者进行比较。我们比较了两组的围手术期和4年事件发生率、2年再狭窄率以及再次手术率。我们还按外科医生专业进一步分析了结果。

结果

有1151例患者接受了CEA(753例[65%]使用补片,329例[29%]一期缝合)。我们排除了44例行外翻式CEA的患者以及25例缺失CEA数据的患者(5%)。补片的使用因外科医生专业而异:89%的血管外科医生、6%的神经外科医生以及76%的胸外科医生使用补片。比较使用补片与未使用补片的患者,2年再狭窄风险显著降低,在按外科医生专业调整后这一结果仍然存在(风险比,0.35;95%置信区间,0.16 - 0.74;P = 0.006)。围手术期中风和死亡率(风险比,1.58;95%置信区间,0.33 - 7.58;P = 0.57)、即刻再次手术率(风险比,0.6;95%置信区间,0.16 - 2.27;P = 0.45)或同侧中风4年风险(风险比,1.23;95%置信区间,0.42 - 3.63;P = 0.71)均无显著差异。

结论

CEA中使用补片缝合与再狭窄减少相关,尽管与改善临床结局无关。因此,应考虑更广泛地使用补片以提高长期耐用性。

临床试验注册网址

http://www.clinicaltrials.gov。唯一标识符:NCT00004732。

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