Department of Cardiology, Nagano Municipal Hospital, Japan (T.M., U.I.).
Department of Cardiovascular Medicine, Shinshu University Hospital, Matsumoto, Japan (Y.M., U.I., K.K.).
Circ Cardiovasc Interv. 2018 Aug;11(8):e006564. doi: 10.1161/CIRCINTERVENTIONS.118.006564.
New-generation bare-metal nitinol (BNS) and drug-eluting stents have improved long-term outcomes in patients undergoing endovascular therapy for femoropopliteal lesions. Furthermore, cilostazol reduces in-stent restenosis (ISR) after first-generation BNS implantation for femoropopliteal lesions.
We studied 255 patients with femoropopliteal lesions treated at 25 cardiovascular centers. Patients were randomly assigned to the BNS group (Misago stent implantation without cilostazol), BNS with cilostazol group (Misago stent implantation with cilostazol), or drug-eluting stents group (Zilver PTX stent implantation without cilostazol). Primary end point was 1-year restenosis noted using duplex ultrasound (peak systolic velocity ratio, >2.0). Secondary end point was major adverse limb events (limb-related death, target lesion revascularization, major amputation, and major bleeding). During the 1-year follow-up, 12 patients (4.7%) died and 237 (92.9%) had relevant ultrasound findings. The 1-year ISR rate did not differ significantly among the BNS, BNS with cilostazol, and drug-eluting stents groups (28.4% versus 12.2% versus 21.0%; P=0.052). Although the 1-year ISR rate was significantly lower in the BNS with cilostazol group than in the BNS group, it was similar to that in the drug-eluting stents group ( P=0.16). Major adverse limb event was significantly higher in the BNS group (16.9% versus 6.5% versus 6.3%; P=0.034); however, target lesion revascularization and major bleeding were similar (9.7% versus 5.1% versus 3.6%; P=0.25, 4.8% versus 1.2% versus 2.4%; P=0.37, respectively).
Misago stent implantation with cilostazol showed a comparable 1-year ISR rate with Zilver PTX. Cilostazol reduced the 1-year ISR rate after endovascular therapy when used with new-generation BNS.
URL: http://www.umin.ac.jp/ctr/ . Unique identifier: UMIN 000010071.
新一代的镍钛诺（BNS）裸金属支架和药物洗脱支架改善了接受腔内治疗的股腘病变患者的长期预后。此外，西洛他唑降低了第一代 BNS 植入治疗股腘病变后的支架内再狭窄（ISR）。
我们研究了 255 名在 25 个心血管中心接受股腘病变治疗的患者。患者被随机分配到 BNS 组（无西洛他唑的 Misago 支架植入）、BNS 加西洛他唑组（有西洛他唑的 Misago 支架植入）或药物洗脱支架组（无西洛他唑的 Zilver PTX 支架植入）。主要终点是通过双功能超声（峰值收缩速度比>2.0）检测到的 1 年再狭窄。次要终点是主要肢体不良事件（与肢体相关的死亡、靶病变血运重建、大截肢和大出血）。在 1 年的随访期间，12 名患者（4.7%）死亡，237 名患者（92.9%）有相关的超声发现。BNS、BNS 加西洛他唑和药物洗脱支架组的 1 年 ISR 率无显著差异（28.4%比 12.2%比 21.0%；P=0.052）。虽然 BNS 加西洛他唑组的 1 年 ISR 率明显低于 BNS 组，但与药物洗脱支架组相似（P=0.16）。BNS 组的主要肢体不良事件发生率明显较高（16.9%比 6.5%比 6.3%；P=0.034）；然而，靶病变血运重建和大出血的发生率相似（9.7%比 5.1%比 3.6%；P=0.25，4.8%比 1.2%比 2.4%；P=0.37）。
西洛他唑联合 Misago 支架植入的 1 年 ISR 率与 Zilver PTX 相似。当与新一代 BNS 联合使用时，西洛他唑降低了腔内治疗后的 1 年 ISR 率。
网址：http://www.umin.ac.jp/ctr/ 。唯一标识符：UMIN 000010071。
