Penetration rate of the placement of a drug-eluting stent for the treatment of superficial femoral artery lesions in Japan

Abstract

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.

Increase in skin perfusion pressure predicts amputation-free survival after lower extremity bypass surgery for critical limb ischemia

“…Although it may not be as powerful and effective as the two significant factors, an odds ratio of 1.8 leads us to think there is a high possibility of this factor becoming significant when the number of patients increased. As EVT is becoming the first choice for femoropopliteal lesions, [32][33][34][35][36] its use for femoropopliteal lesions combined with below-the-knee bypass may result in good recovery of SPP.…”

Meta-analysis of outcomes from drug-eluting stent implantation in femoropopliteal arteries

“…There was only one paper was from a single center rather than multiple centers [ 15 ]. Three papers only included de novo FP lesions [ 14 , 17 , 32 ], two also included restenosis lesions [ 16 , 31 ], and two did not mention this aspect of pathological characteristics [ 15 , 33 ]. The arms in each study were independent with no patient conversions, and the stents implantations were all primary, that is, regardless of whether PTAs had been performed previously or their effects, except for 1 paper [ 16 ].…”

“…After assessment, the overall risk of bias in 2 included studies was "high" [ 16 , 32 ], in four it was "some concerns" [ 14 , 15 , 17 , 31 ], and in one it was "low" [ 33 ]. The detailed final assessment results are shown in Table 3 .…”

“…Three studies [ 16 , 17 , 33 ] gave the K-M survival curves and another [ 14 ] reported the HR directly. The result of one [ 16 ] of them was particularly in favor of DESI (P = 0.003), whereas those of the other three were not (P >0.05).…”

“…A similar condition also occurred between the other two RCTs. Dake et al reported in 2016 that DES had better primary patency (PP) postoperatively compared with BMS (Log-Rank test, P = 0.03) [ 16 ]; however, Mori et al reported in 2017 that there was no significant difference between them (P = 0.52) [ 17 ]. At present, there are few meta-analyses on relevant RCTs.…”