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肝素附着聚四氟乙烯内衬支架在下肢闭赛性病变中的应用 : VIPER一年试验研究.

Heparin-bonded,expandedpolytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial.

Abstract

PURPOSE:To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency.

MATERIALS AND METHODS:

In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio< 2.5.

RESULTS:

At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P<.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized<20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by>20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%.

CONCLUSIONS:

The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes.

【简单翻译】

 

肝素附着聚四氟乙烯内衬支架在下肢闭赛性病变中的应用 : VIPER一年试验研究.

摘要

目的探讨肝素化覆膜支架在长段下肢闭塞性病变中的疗效以及探讨

闭塞的因素.

材料和方法:在一个单臂多中心(11)前瞻性研究中,入选119条肢体(113例患者69,平均年龄67.包括罗斯福分级3-5级患者88,(TASC II) CD分级72,均使用腔内支架治疗,治疗平均长度 19cm,闭塞率超过56%.所有病例均通过彩超随访.

结果:

12个月,卢瑟福分级和踝肱指数均明显提高(分级提高2.4,踝肱指数由0.6±0.2提高到0.9±0.19)一期和二期通畅率分别为73%92.并且初期通畅率未受病变长度和直径的影响,30天的不良反应为0.8.

结论:

肝素结合覆膜支架的初期通畅率为73%,锚定曲精确直径的定位可能是成功的关键。

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