Center for Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany.
Cardiology Unit, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy.
JACC Cardiovasc Interv. 2014 Mar;7(3):305-12. doi: 10.1016/j.jcin.2013.09.009. Epub 2014 Feb 13.
This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease.
Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery.
A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events.
The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients.
The GAIA (Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral Artery) study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period.
本研究旨在评估 Igaki-Tamai（日本京都 Igaki 医疗规划公司）可生物降解支架在闭塞性股浅动脉（SFA）疾病患者中的安全性和性能。
聚 L-乳酸（PLLA）可生物降解支架已被证明在冠状动脉中有效，但在股动脉中尚无其疗效的数据。
前瞻性、多中心、非随机研究纳入了 30 名患有症状性首发 SFA 疾病并接受 Igaki-Tamai 生物可吸收支架植入的患者。在 1、6、9 和 12 个月后，前瞻性地进行临床检查和双功能超声检查。主要研究终点为技术成功率、再狭窄率、靶病变血运重建率（TLR）、踝肱指数（ABI）变化和通过评估行走障碍问卷（WIQ）评估的生活质量。通过监测主要不良临床事件和严重不良事件来评估安全性。
患者的平均年龄为 67.7 岁，77%为男性。平均病变长度为 5.9cm。支架植入后，平均直径狭窄率从 89.9%降至 6.2%。技术成功率为 96.7%。6 个月和 12 个月的随访时，二元再狭窄率分别为 39.3%和 67.9%。TLR 率在 6 个月时为 25.0%，12 个月时为 57.1%。所有 TLR 均成功；1 年后的二级通畅率为 89.3%。与基线相比，ABI 在 53.6%的患者中增加。即使再干预率较高，功能终点（WIQ）也显示出大多数患者的改善。
GAIA（评价可生物降解外周 Igaki-Tamai 支架治疗股浅动脉首发病变的疗效）研究表明，使用可生物降解 PLLA 支架（Igaki-Tamai）时，即刻血管造影结果与金属支架的结果相当，在 1 年后获得较高的二级通畅率。需要对支架特征和技术进行修改，以降低再吸收期的再狭窄率。
