Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up.
BACKGROUND
Recent technical advances have made endovascular treatment (EVT) an alternative first-line treatment for critical limb ischemia.


RESULTS
A prospective multicenter study was conducted to evaluate the clinical outcomes of 314 Japanese critical limb ischemia patients (mean age, 73±10 years) with infrainguinal arterial lesions who underwent EVT. Patients were enrolled from December 2009 to July 2011 and were followed-up for 12 months. The primary end point was amputation-free survival (AFS) at 12 months. Secondary end points were anatomic, clinical, and hemodynamic measures, including 12-month freedom from major adverse limb events. The 12-month AFS rate was 74%, with body mass index <18.5 (hazard ratio [HR], 2.22; P=0.008), heart failure (HR, 1.73; P=0.04), and wound infection (HR, 1.89; P=0.03) associated with a poor prognosis for AFS. The 12-month major adverse limb event-free rate was 88%, with hemodialysis (HR, 1.98; P=0.005), heart failure (HR, 1.69; P=0.02), and Rutherford classification 6 (HR, 2.25; P=0.002) associated with a poor prognosis for major adverse limb events. The median time for wound healing was 97 days, with body mass index <18.5 (HR, 0.54; P=0.03) and wound infection (HR, 0.60; P=0.04) being significant risk factors for unhealed wounds after EVT. At 12 months, 34% had undergone reintervention (bypass surgery, 2.6%; repeat EVT, 31.7%), and 73% were major adverse event-free.


CONCLUSIONS
The high reintervention rate notwithstanding, EVT was an effective treatment for Japanese critical limb ischemia patients with infrainguinal disease, with satisfactory AFS and major adverse limb event-free rates. The results of this study will be helpful for the future evaluation of critical limb ischemia therapy.


BACKGROUND
URL: http://www.umin.ac.jp/ctr. Unique identifier: UMIN000002830.
Cardiovascular Center, Kansai Rosai Hospital, Hyogo, Japan.
Osamu
O
Iida
Masato
M
Nakamura
Yasutaka
Y
Yamauchi
Daizo
D
Kawasaki
Yoshiaki
Y
Yokoi
Hiroyoshi
H
Yokoi
Yoshimistu
Y
Soga
Kan
K
Zen
Keisuke
K
Hirano
Nobuhiro
N
Suematsu
Naoto
N
Inoue
Kenji
K
Suzuki
Yoshiaki
Y
Shintani
Yusuke
Y
Miyashita
Kazushi
K
Urasawa
Ikuro
I
Kitano
Terutoshi
T
Yamaoka
Takashi
T
Murakami
Michitaka
M
Uesugi
Taketsugu
T
Tsuchiya
Toshiro
T
Shinke
Yasuhiro
Y
Oba
Norihiko
N
Ohura
Toshimitsu
T
Hamasaki
Shinsuke
S
Nanto
D000368:Aged; D001158:Arteries / Q000473:pathology / Q000601:surgery*; D057510:Endovascular Procedures / Q000379:methods*; D005121:Extremities / Q000098:blood supply* / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007264:Inguinal Canal / Q000473:pathology; D007511:Ischemia / Q000601:surgery*; D007564:Japan; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000601:surgery*; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome; D014945:Wound Healing