Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up.

Abstract

BACKGROUND:

Recent technical advances have made endovascular treatment (EVT) an alternative first-line treatment for critical limb ischemia.

METHODS AND 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.

CLINICAL TRIAL REGISTRATION:

URL: http://www.umin.ac.jp/ctr. Unique identifier: UMIN000002830.

• Authors: Osamu Iida, Masato Nakamura, Yasutaka Yamauchi, Daizo Kawasaki, Yoshiaki Yokoi, Hiroyoshi Yokoi, Yoshimistu Soga, Kan Zen, Keisuke Hirano, Nobuhiro Suematsu, Naoto Inoue, Kenji Suzuki, Yoshiaki Shintani, Yusuke Miyashita, Kazushi Urasawa, Ikuro Kitano, Terutoshi Yamaoka, Takashi Murakami, Michitaka Uesugi, Taketsugu Tsuchiya, Toshiro Shinke, Yasuhiro Oba, Norihiko Ohura, Toshimitsu Hamasaki, Shinsuke Nanto, OLIVE Investigators
• Journal: Circulation. Cardiovascular interventions (Circ Cardiovasc Interv) Vol. 6 Issue 1 Pg. 68-76 (Feb 2013) ISSN: 1941-7632 [Electronic] United States
• PMID: 23362307 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Arteries (pathology, surgery)
• Endovascular Procedures (methods)
• Extremities (blood supply, pathology, surgery)
• Female
• Follow-Up Studies
• Humans
• Inguinal Canal (pathology)
• Ischemia (surgery)
• Japan
• Male
• Middle Aged
• Peripheral Arterial Disease (surgery)
• Prospective Studies
• Registries
• Treatment Outcome
• Wound Healing