Tamai H, Igaki K, Kyo E, Kosuga K, Kawashima A, Matsui S, Komori H, Tsuji T, Motohara S, Uehata H
Department of Cardiology, Shiga Medical Center for Adults, Shiga, Japan.
Circulation. 2000 Jul 25;102(4):399-404. doi: 10.1161/01.cir.102.4.399.
Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent.
Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months.
Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.
尽管金属支架在预防冠状动脉成形术后急性闭塞和减少晚期再狭窄方面有效，但仍存在许多问题。与金属支架相比，聚左旋乳酸（PLLA）支架可生物降解且能局部给药。本研究的目的是评估PLLA支架的可行性、安全性和有效性。
15例患者因冠状动脉狭窄选择性地接受了PLLA伊加基-玉井支架植入术。伊加基-玉井支架由PLLA单一聚合物制成，厚度为0.17mm，呈锯齿状螺旋线圈图案。使用球囊可扩张覆膜鞘管系统，支架在适当温度下自行扩张至原始尺寸。15例患者的19处病变共成功植入25枚支架，所有手术均取得血管造影成功。30天内未发生支架血栓形成和重大心脏事件。术后1天、3个月和6个月连续进行冠状动脉造影和血管内超声检查。血管造影显示，每个病变的再狭窄率和靶病变血管重建率均为10.5%；6个月时每位患者的发生率为6.7%。血管内超声检查结果显示，术后1天无明显支架回缩，随访时显示支架扩张。6个月内除再次血管成形术外，未发生重大心脏事件。
我们的初步经验表明，冠状动脉PLLA可生物降解支架在人体中是可行、安全且有效的。需要对更多患者进行长期随访以验证PLLA支架的长期疗效。
