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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-04-27

AUTHORS

Shinsuke Mori, Keisuke Hirano, Yasutaka Yamauchi, Eijiro Hayashi, Tatsuki Doijiri, Takeshi Takamura, Atsuo Maeda, Jun Okuda, Koichi Mizuno, Yuko Onishi, Taku Iwaki, Kengo Tsukahara, Norihiko Shinozaki, Hiroshi Araki, Ken Kongoji, Teruyasu Sugano, Akira Miyamoto, Ichiro Michishita

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. More... »

PAGES

1093-1098

Journal

TITLE

Heart and Vessels

ISSUE

9

VOLUME

32

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00380-017-0982-7

DOI

http://dx.doi.org/10.1007/s00380-017-0982-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085074110

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28451834


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25 schema:description 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.
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33 Japan
34 PTX
35 SFA lesions
36 Secondary endpoints
37 TASC II C/D lesions
38 Zilver PTX
39 Zilver PTX stent
40 adverse limb events
41 age
42 artery lesions
43 bare metal stents
44 baseline
45 cilostazol
46 critical limb ischemia
47 diabetes mellitus
48 drug-eluting stents
49 endpoint
50 events
51 female patients
52 femoral artery lesions
53 freedom
54 hand
55 hemodialysis
56 ischemia
57 length
58 lesion length
59 lesion revascularization
60 lesions
61 limb
62 limb events
63 limb ischemia
64 major adverse limb events
65 mean age
66 mean lesion length
67 measurements
68 mellitus
69 months
70 multicenter registry study
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72 patency
73 patency rates
74 patients
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78 primary endpoint
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82 rate
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84 registry study
85 restenosis
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