Mori Shinsuke, Hirano Keisuke, Yamauchi Yasutaka, Hayashi Eijiro, Doijiri Tatsuki, Takamura Takeshi, Maeda Atsuo, Okuda Jun, Mizuno Koichi, Onishi Yuko, Iwaki Taku, Tsukahara Kengo, Shinozaki Norihiko, Araki Hiroshi, Kongoji Ken, Sugano Teruyasu, Miyamoto Akira, Michishita Ichiro
Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.
Cardiovascular Center, Takatsu General Hospital, Kawasaki, Japan.
Heart Vessels. 2017 Sep;32(9):1093-1098. doi: 10.1007/s00380-017-0982-7. Epub 2017 Apr 27.
Stent placement for treating superficial femoral artery (SFA) lesions has been approved. The Zilver PTX stent, a drug-eluting stent (DES) for treating SFA lesions, has been available in Japan since 2012. However, the penetration rate of this DES has not yet been reported. This prospective multicenter registry study enrolled 314 patients (354 limbs) to be treated by stent placement in 2014 (UMIN000011551). The primary endpoint was the measurement of the penetration rate of the DES. The secondary endpoints were measuring the freedom from restenosis, freedom from target lesion revascularization (TLR), freedom from major adverse limb event (MALE), and the survival rate at 12 months postoperatively. Female patients comprised 28% participants. The mean age was 73.1 ± 9.2 years. A total of 56% patients had diabetes mellitus (DM), 36% patients were receiving hemodialysis, and 30% used cilostazol at baseline. The mean lesion length was 156 ± 101 mm, and the percentage of TASC II C/D lesions was 58%. Critical limb ischemia (CLI) was observed in 32% limbs. The penetration rates of the Zilver PTX stent were only 8%. The primary patency rate was similar between DES and bare-metal stents (BMS) at 12 months postoperatively (77 vs. 84%, p = 0.52). In this study, the rates of freedom from restenosis, freedom from TLR, freedom from MALE, and the survival rate at 12 months postoperatively were 83, 86, 85, and 89%, respectively. The penetration rate of a first-generation DES placement for treating SFA lesions is low in Japan. On the other hand, BMS is well utilized and its primary patency is acceptable.
用于治疗股浅动脉（SFA）病变的支架置入术已获批准。Zilver PTX支架是一种用于治疗SFA病变的药物洗脱支架（DES），自2012年起在日本上市。然而，该DES的渗透率尚未见报道。这项前瞻性多中心注册研究在2014年纳入了314例患者（354条肢体）接受支架置入治疗（UMIN000011551）。主要终点是测量DES的渗透率。次要终点是测量无再狭窄率、无靶病变血管重建（TLR）率、无严重肢体不良事件（MALE）率以及术后12个月的生存率。女性患者占参与者的28%。平均年龄为73.1±9.2岁。共有56%的患者患有糖尿病（DM），36%的患者接受血液透析，30%的患者在基线时使用西洛他唑。平均病变长度为156±101mm，TASC II C/D级病变的比例为58%。32%的肢体观察到严重肢体缺血（CLI）。Zilver PTX支架的渗透率仅为8%。术后12个月时，DES和裸金属支架（BMS）的主要通畅率相似（77%对84%，p = 0.52）。在本研究中，术后12个月的无再狭窄率、无TLR率、无MALE率和生存率分别为83%、86%、85%和89%。在日本，第一代DES用于治疗SFA病变的渗透率较低。另一方面，BMS得到了很好的应用，其主要通畅率是可以接受的。
