title: 3-Year Outcomes of the OLIVE Registry, a Prospective Multicenter Study of Patients With Critical Limb Ischemia: A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia.
abstract: OBJECTIVE
  This study sought to investigate the 3-year follow-up results of OLIVE registry patients.
  
  
  BACKGROUND
  Although favorable 12-month clinical outcomes after endovascular therapy (EVT) in OLIVE registry patients with critical limb ischemia (CLI) from infrainguinal disease have been reported, long-term results after EVT remain unknown.
  
  
  METHODS
  This was a prospective multicenter registry study that consecutively enrolled patients who received infrainguinal EVT for CLI. The primary outcome was 3-year amputation-free survival (AFS), whereas secondary outcome measures were 3-year freedom from major adverse limb events (MALE), wound-free survival, and wound recurrence rate. Prognostic predictors for each outcome were also elucidated by Cox proportional hazard regression analysis or the log-rank test.
  
  
  RESULTS
  The completion rate of 3-year follow-up was 95%. Three-year AFS, freedom from MALE, and wound-free survival rates were 55.2%, 84.0%, and 49.6%, respectively. Wound recurrence out to 3 years was 43.9%. After multivariable analysis, age (hazard ratio [HR]: 1.43, p = 0.001), body mass index ≤18.5 (HR: 2.17, p = 0.001), dialysis (HR: 2.91, p < 0.001), and Rutherford 6 (HR: 1.64, p = 0.047) were identified as predictors of 3-year major amputation or death. Statin use (HR: 0.28, p = 0.02), Rutherford 6 (HR: 2.40, p = 0.02), straight-line flow to the foot (HR: 0.27, p = 0.001), and heart failure (HR: 1.96, p = 0.04) were identified as 3-year MALE predictors. Finally, CLI due to isolated below-the-knee lesion was a wound recurrence predictor (HR: 4.28, p ≤ 0.001). Three-year survival, freedom from major amputation, and reintervention rates were 63.0%, 87.9%, and 43.2%.
  
  
  CONCLUSIONS
  In CLI patients with infrainguinal lesions, 3-year clinical results of EVT were reasonable despite high reintervention and moderate ulcer recurrence rate. (A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia [OLIVE 3-Year Follow-Up Study]; UMIN000014759).
authors.affiliation: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Iida
authors.affiliation: Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo, Japan. Electronic address: masato@oha.toho-u.ac.jp.
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Cardiovascular Center, Kikuna Memorial Hospital, Yokohama, Japan.
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Yamauchi
authors.affiliation: Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Fukunaga
authors.affiliation: Department of Cardiology, Kishiwada Tokushukai Hospital, Osaka, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Yokoi
authors.affiliation: Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.affiliation: Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan.
authors.forename: Yoshimistu
authors.initials: Y
authors.lastname: Soga
authors.affiliation: Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Zen
authors.affiliation: Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Suematsu
authors.affiliation: Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Inoue
authors.affiliation: Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Suzuki
authors.affiliation: Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Hirano
authors.affiliation: Department of Cardiology, Shin-Koga Hospital, Kurume, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Shintani
authors.affiliation: Department of Cardiovascular Medicine, Shinshu University Graduate School of Medicine, Matsumoto, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Miyashita
authors.affiliation: Cardiovascular Center, Tokeidai Memorial Hospital, Sapporo, Japan.
authors.forename: Kazushi
authors.initials: K
authors.lastname: Urasawa
authors.affiliation: Wound Treatment Center, Shin-Suma General Hospital, Kobe, Japan.
authors.forename: Ikuro
authors.initials: I
authors.lastname: Kitano
authors.affiliation: Division of Trans-Catheter Therapeutics, Kanazawa Medical University Hospital, Kahoku, Japan.
authors.forename: Taketsugu
authors.initials: T
authors.lastname: Tsuchiya
authors.affiliation: Department of Cardiology, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kawamoto
authors.affiliation: Department of Vascular Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.
authors.forename: Terutoshi
authors.initials: T
authors.lastname: Yamaoka
authors.affiliation: Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan.
authors.forename: Michitaka
authors.initials: M
authors.lastname: Uesugi
authors.affiliation: Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Shinke
authors.affiliation: Department of Surgery, Kasugai Municipal Hospital, Kasugai, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Oba
authors.affiliation: Department of Plastic and Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan.
authors.forename: Norihiko
authors.initials: N
authors.lastname: Ohura
authors.affiliation: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Uematsu
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Takahara
authors.affiliation: Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Hamasaki
authors.affiliation: Nishinomiya Municipal Central Hospital, Nishinomiya, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D016638:Critical Illness; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000401:mortality; D005260:Female; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D007564:Japan; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
keywords: amputation-free survival; critical limb ischemia; endovascular treatment; major adverse limb event