Rundback John H, Peeters Patrick, George Jon C, Jaff Michael R, Faries Peter L
1 Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.
2 Imelda Hospital, Bonheiden, Belgium.
J Endovasc Ther. 2017 Jun;24(3):342-348. doi: 10.1177/1526602817692960. Epub 2017 Feb 1.
To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions.
Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed.
Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender.
Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.
评估使用Visi-Pro球囊扩张式外周支架系统对股总动脉（CIA）或髂外动脉（EIA）进行初次支架置入术治疗狭窄、再狭窄或闭塞性病变的安全性和有效性。
2011年至2012年期间，75例患者（平均年龄64.2±8.9岁；46例男性），患有卢瑟福分级2 - 4级缺血且动脉粥样硬化病变长度≤10 cm，在美国和欧洲的17个中心接受了髂动脉支架置入术。该研究的主要结局是术后9个月的主要不良事件（MAE）发生率[围手术期死亡、住院期间心肌梗死、临床驱动的靶病变血运重建（CD-TLR）和治疗肢体截肢的综合发生率]。次要结局包括30天MAE发生率、9个月的初次通畅率、术后30天和9个月时踝肱指数（ABI）及步行障碍问卷的变化、器械成功率以及术后30天和9个月时临床驱动的靶血管血运重建（CD-TVR）。分析了特定患者队列（即性别、支架置入部位、钙化严重程度和病变分级）的结局。
在61处CIA病变和15处EIA病变（41处有中度/重度钙化）中植入了81枚支架。平均治疗病变长度为29.3±13.9 mm。所有器械均成功置入。75例受试者中有3例（4.0%）在9个月时发生MAE。术后9个月的初次通畅率和无CD-TVR率均为95.8%。ABI从基线时的0.67±0.14分别改善至术后30天的0.94±0.14和9个月随访时的0.96±0.16（两者p均<0.001）。在包括性别在内的任何分析患者特征方面均无差异。
VISIBILITY髂动脉支架研究（ClinicalTrials.gov标识符NCT01402700）的9个月结果表明，使用Visi-Pro支架治疗所有治疗队列中的动脉粥样硬化CIA和EIA病变具有安全性和有效性。
