Drug-Eluting Stent vs Percutaneous Transluminal Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis: Results From a Retrospective 1-Year Multicenter Study.
OBJECTIVE
To compare drug-eluting stent (DES) implantation with percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal in-stent restenosis (ISR).


METHODS
A comparison was performed of data from 112 ZEPHYR registry patients (mean age 74±9 years; 60 men) with 119 femoropopliteal ISR lesions treated with a drug-eluting stent (Zilver PTX) with historical data from 116 patients (mean age 72±8 years; 83 men) with 133 lesions treated with PTA. The patients were stratified for analysis by lesions with (101/252, 40%) and without (n=151) in-stent occlusion. The primary outcome measure was the 1-year incidence of recurrent restenosis; the secondary outcome was major adverse limb events (MALE). Multivariate logistic regression analysis was performed to look for any independent association of DES implantation with 1-year recurrent restenosis in the respective subgroups; results are presented as the odds ratio (OR) and 95% confidence interval (CI).


RESULTS
In the subgroup without in-stent occlusion, there was no significant difference between DES and PTA in the 1-year incidence of recurrent restenosis (40.5% vs 45.7%, p=0.583, respectively) or MALE (27.8% vs 20.7%, p=0.322, respectively). However, in the subgroup with in-stent occlusion, DES implantation was associated with significantly lower incidences of recurrent restenosis (44.1% vs 90.3% for PTA, p<0.001) and MALE (25.5% vs 53.6% for PTA, p<0.001). Multivariate analysis confirmed that DES implantation had a significant independent negative association with the risk of recurrent restenosis in the subgroup with occlusion (OR 0.2, 95% CI 0.1 to 0.6, p=0.006).


CONCLUSIONS
DES implantation may be more effective than PTA in the management of femoropopliteal ISR with occlusion, but equally effective to PTA in nonocclusive ISR lesions. These results require confirmation in prospective randomized studies.
Department of Cardiology, Tokyo Medical University, Tokyo, Japan metallion2@yahoo.co.jp.
Naotaka
N
Murata
Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Mitsuyoshi
M
Takahara
Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Yoshimitsu
Y
Soga
Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Kanagawa, Japan.
Masatsugu
M
Nakano
Cardiovascular Center, Takatsu General Hospital, Kanagawa, Japan.
Yasutaka
Y
Yamauchi
Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan.
Kan
K
Zen
Cardiovascular Division, Department of Internal Medicine, Morinomiya Hospital, Osaka, Japan.
Daizo
D
Kawasaki
Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka, Japan.
Hiroyoshi
H
Yokoi
Department of Cardiology, Kawakita General Hospital, Tokyo, Japan.
Atsushi
A
Tosaka
Department of Cardiology, Tokyo Medical University, Tokyo, Japan.
Nobuhiro
N
Tanaka
Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
Osamu
O
Iida
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007564:Japan; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
drug-eluting stents; femoropopliteal segment; in-stent occlusion; in-stent restenosis; percutaneous transluminal angioplasty; peripheral artery disease; recurrent restenosis