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 |
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| Affiliation: | 1. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan;2. Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo, Japan;3. Cardiovascular Center, Kikuna Memorial Hospital, Yokohama, Japan;4. Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan;6. Department of Cardiology, Kishiwada Tokushukai Hospital, Osaka, Japan;5. Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan;7. Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan;11. Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan;12. Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan;8. Department of Cardiology, Shin-Koga Hospital, Kurume, Japan;10. Department of Cardiovascular Medicine, Shinshu University Graduate School of Medicine, Matsumoto, Japan;9. Cardiovascular Center, Tokeidai Memorial Hospital, Sapporo, Japan;71. Division of Trans-Catheter Therapeutics, Kanazawa Medical University Hospital, Kahoku, Japan;112. Department of Cardiology, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Japan;123. Department of Vascular Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan;84. Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan;106. Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan;95. Department of Surgery, Kasugai Municipal Hospital, Kasugai, Japan;77. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan;1111. Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Suita, Japan;1212. Nishinomiya Municipal Central Hospital, Nishinomiya, Japan |
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| Abstract: | ObjectivesThis study sought to investigate the 3-year follow-up results of OLIVE registry patients.BackgroundAlthough 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.MethodsThis 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.ResultsThe 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%.ConclusionsIn 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) |
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| Keywords: | amputation-free survival critical limb ischemia endovascular treatment major adverse limb event AFS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0035" }," $$" :[{" #name" :" text" ," _" :" amputation-free survival BMI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0045" }," $$" :[{" #name" :" text" ," _" :" body mass index BTK" },{" #name" :" keyword" ," $" :{" id" :" kwrd0055" }," $$" :[{" #name" :" text" ," _" :" below-the-knee BSX" },{" #name" :" keyword" ," $" :{" id" :" kwrd0065" }," $$" :[{" #name" :" text" ," _" :" bypass surgery CI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0075" }," $$" :[{" #name" :" text" ," _" :" confidence interval CLI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0085" }," $$" :[{" #name" :" text" ," _" :" critical limb ischemia EVT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0095" }," $$" :[{" #name" :" text" ," _" :" endovascular treatment HR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0105" }," $$" :[{" #name" :" text" ," _" :" hazard ratio MALE" },{" #name" :" keyword" ," $" :{" id" :" kwrd0115" }," $$" :[{" #name" :" text" ," _" :" major adverse limb event(s) PH" },{" #name" :" keyword" ," $" :{" id" :" kwrd0125" }," $$" :[{" #name" :" text" ," _" :" proportional hazard |
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