Massachusetts General Hospital Vascular Center, 55 Fruit Street, GB 800, Boston, MA 02114, USA.
J Vasc Interv Radiol. 2010 Oct;21(10):1489-94. doi: 10.1016/j.jvir.2010.06.013.
To evaluate the 2-year outcomes of safety and effectiveness for iliac artery stent placement and examine the effects of placement in the common iliac artery (CIA) and external iliac artery (EIA), the degree of initial stenosis, and patient gender on success.
Zilver vascular stents (Cook Inc., Bloomington, Indiana) were placed in 151 consecutive patients whose iliac arteries remained stenotic after percutaneous transluminal angioplasty (PTA). Success at 2 years was determined by patency, ankle-brachial index (ABI) scores, and Walking Impairment Questionnaire (WIQ) scores.
Patency, ABI measurements, and WIQ scores showed improvement at 2 years, compared with preprocedure measurements. Kaplan-Meier estimate of overall patency at 2 years was 90% (n = 117). Significant improvement in ABI and WIQ scores was seen at 2 years, compared with preprocedural values (P < .01). The 2-year overall success rate was 91%. The degree of initial stenosis, stent location, and patient gender did not affect the success of the Zilver stent (P = .65, P = .58, and P = .77). The Kaplan-Meier estimate of the probability of experiencing a major adverse event (MAE) related to the device or stent placement procedure by the 2-year follow-up was 2.7%.
The Zilver vascular stent remains durable at 2 years in regard to safety and clinical effectiveness, and is effective in the CIA and EIA both in male and female patients.
评估髂动脉支架置入术的 2 年安全性和有效性结果,并研究支架置入部位(髂总动脉和髂外动脉)、初始狭窄程度以及患者性别对手术成功率的影响。
对 151 例接受经皮腔内血管成形术(PTA)治疗后仍存在狭窄的髂动脉患者进行 Zilver 血管支架置入术。2 年时的成功标准为通畅率、踝肱指数(ABI)和步行障碍问卷(WIQ)评分。
与术前相比,2 年时的通畅率、ABI 测量值和 WIQ 评分均有所改善。Kaplan-Meier 估计 2 年总体通畅率为 90%(n = 117)。ABI 和 WIQ 评分在 2 年时较术前明显改善(P <.01)。2 年总体成功率为 91%。初始狭窄程度、支架位置和患者性别均不影响 Zilver 支架的手术成功率(P =.65、P =.58 和 P =.77)。Kaplan-Meier 估计在 2 年随访时与器械或支架置入相关的主要不良事件(MAE)的概率为 2.7%。
Zilver 血管支架在 2 年时的安全性和临床有效性方面保持持久,在男性和女性患者的髂总动脉和髂外动脉中均有效。