Silingardi Roberto, Lauricella Antonio, Coppi Giovanni, Nicolosi Emanuele, Gennai Stefano, Coppi Gioacchino
Department of Vascular Surgery, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara, University of Modena and Reggio Emilia, Via Giardini 1355, 41100 Baggiovara (MO), Italy.
Department of Vascular Surgery, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara, University of Modena and Reggio Emilia, Via Giardini 1355, 41100 Baggiovara (MO), Italy.
J Vasc Interv Radiol. 2015 Mar;26(3):374-81.e1. doi: 10.1016/j.jvir.2014.10.050. Epub 2015 Jan 28.
To assess the midterm efficacy of a biodegradable poly-l-lactic acid (PLLA) stent in the treatment of superficial femoral artery (SFA) occlusive disease.
Between June 2009 and April 2011, 35 de novo SFA lesions were treated with 43 biodegradable stents. This nonrandomized, retrospective, single-center study included patients with moderate or severe claudication, lower-limb rest pain, or ischemic ulceration restricted to the toes; symptoms were classified as Rutherford category 2 (48.6%), 3 (37.1%), 4 (8.6%), or 5 (5.7%). The population included 28 men and had a mean age of 71 years (range, 51-81 y). Follow-up included clinical examination and color-flow duplex imaging. Mean follow-up was 38.3 months (range, 30-58 mo).
Technical success was reported in all patients (100%). There were no intraoperative or immediate (< 30 d) complications.. During follow-up, one in-stent occlusion and seven in-stent restenoses occurred, all of which were successfully treated with percutaneous transluminal angioplasty. Primary and secondary patency rates were 77.1% and 97.1% at 24 and 36 months, respectively. No stent recoil or stent fracture was encountered. Late follow-up (> 12 mo) by ultrasound confirmed total reabsorption of the stent structures. Clinical improvement (ie, an upward shift of at least two Rutherford categories) was achieved in all 35 patients.
Midterm results for biodegradable PLLA stents for atherosclerotic SFA lesions were associated with high technical success and secondary patency rates, without stent recoil and vessel remodeling.
评估可生物降解的聚左旋乳酸(PLLA)支架治疗股浅动脉(SFA)闭塞性疾病的中期疗效。
2009年6月至2011年4月期间,对35例新发SFA病变患者使用43个可生物降解支架进行治疗。这项非随机、回顾性、单中心研究纳入了有中度或重度间歇性跛行、下肢静息痛或仅限于脚趾的缺血性溃疡的患者;症状分类为卢瑟福分级2级(48.6%)、3级(37.1%)、4级(8.6%)或5级(5.7%)。研究人群包括28名男性,平均年龄为71岁(范围51 - 81岁)。随访包括临床检查和彩色血流双功成像。平均随访时间为38.3个月(范围30 - 58个月)。
所有患者均报告技术成功(100%)。无术中或近期(< 30天)并发症。随访期间,发生1例支架内闭塞和7例支架内再狭窄,所有这些均通过经皮腔内血管成形术成功治疗。24个月和36个月时的一期通畅率和二期通畅率分别为77.1%和97.1%。未遇到支架回缩或支架断裂情况。超声晚期随访(> 12个月)证实支架结构完全吸收。所有35例患者均实现了临床改善(即至少上升两个卢瑟福分级)。
可生物降解PLLA支架治疗动脉粥样硬化性SFA病变的中期结果显示技术成功率和二期通畅率高,无支架回缩和血管重塑。