Zeller Thomas, Peeters Patrick, Bosiers Marc, Lammer Johannes, Brechtel Klaus, Scheinert Dierk, Rastan Aljoscha, Noory Elias, Beschorner Ulrich
1 Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
J Endovasc Ther. 2014 Dec;21(6):765-74. doi: 10.1583/14-4790R.1.
Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 ± 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 ± 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within ± 10% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results : The median follow-up was 12.3 months (mean 12.3 ± 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion : This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. One-year primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.
确认带有Propaten生物活性表面的25厘米Viabahn血管内支架在治疗股浅动脉和腘动脉近端初发和/或再狭窄的跨大西洋协作组（TASC）II C型和D型病变时的性能和安全性。方法：25厘米Gore Viabahn血管内支架研究（ClinicalTrials.gov标识符NCT01263665）是一项前瞻性、多中心、单臂研究，纳入了71例患者（50例男性；平均年龄66.7±8.34岁），这些患者有影响生活方式的间歇性跛行（卢瑟福分级2至4级）且病变长度超过20厘米（平均长度26.5±5.31厘米，范围20 - 40厘米）。大多数病变（92.9%）为完全闭塞。主要性能指标是通过定量血管分析血管造影确定的术后支架长度在术前支架长度的±10%范围内。主要安全指标是在术后30天内发生的与器械和手术相关的严重不良事件。患者在1个月和1年时接受随访检查。结果：中位随访时间为12.3个月（平均12.3±0.6）。9例（12.7%）患者因不同原因退出研究，包括2例旁路手术。60例患者有血管造影结果以确定主要性能指标，所有病例均达到该指标。2例（2.8%）患者在30天随访期间发生了与手术/器械相关的不良事件（夹层）。1年主要通畅率和次要通畅率的Kaplan-Meier估计值分别为67.0%[95%置信区间（CI）53.5%至77.3%]和96.9%（95%CI 88.0%至99.2%）。1个月和12个月时踝肱指数和卢瑟福分级的变化均显示持续改善。结论：本研究证实，25厘米Viabahn血管内支架在急性情况下按预期发挥作用，在用于复杂股腘病变时是安全的。1年主要通畅率和次要通畅率令人满意，与既往人工血管旁路移植术的结果相当。
