Osamu Iida1, Masato Nakamura2, Yasutaka Yamauchi3, Masashi Fukunaga4, Yoshiaki Yokoi5, Hiroyoshi Yokoi6, Yoshimistu Soga6, Kan Zen7, Nobuhiro Suematsu8, Naoto Inoue9, Kenji Suzuki9, Keisuke Hirano10, Yoshiaki Shintani11, Yusuke Miyashita12, Kazushi Urasawa13, Ikuro Kitano14, Taketsugu Tsuchiya15, Kenji Kawamoto16, Terutoshi Yamaoka17, Michitaka Uesugi18, Toshiro Shinke19, Yasuhiro Oba20, Norihiko Ohura21, Masaaki Uematsu1, Mitsuyoshi Takahara22, Toshimitsu Hamasaki23, Shinsuke Nanto24. 1. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan. 2. Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo, Japan. Electronic address: masato@oha.toho-u.ac.jp. 3. Cardiovascular Center, Kikuna Memorial Hospital, Yokohama, Japan. 4. Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan. 5. Department of Cardiology, Kishiwada Tokushukai Hospital, Osaka, Japan. 6. Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan. 7. Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan. 8. Department of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan. 9. Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan. 10. Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan. 11. Department of Cardiology, Shin-Koga Hospital, Kurume, Japan. 12. Department of Cardiovascular Medicine, Shinshu University Graduate School of Medicine, Matsumoto, Japan. 13. Cardiovascular Center, Tokeidai Memorial Hospital, Sapporo, Japan. 14. Wound Treatment Center, Shin-Suma General Hospital, Kobe, Japan. 15. Division of Trans-Catheter Therapeutics, Kanazawa Medical University Hospital, Kahoku, Japan. 16. Department of Cardiology, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Japan. 17. Department of Vascular Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan. 18. Department of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan. 19. Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. 20. Department of Surgery, Kasugai Municipal Hospital, Kasugai, Japan. 21. Department of Plastic and Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan. 22. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan. 23. Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Suita, Japan. 24. Nishinomiya Municipal Central Hospital, Nishinomiya, Japan.
Abstract
OBJECTIVES: 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).
OBJECTIVES: 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: Maria Teresa B Abola; Jonathan Golledge; Tetsuro Miyata; Seung-Woon Rha; Bryan P Yan; Timothy C Dy; Marie Simonette V Ganzon; Pankaj Kumar Handa; Salim Harris; Jiang Zhisheng; Ramakrishna Pinjala; Peter Ashley Robless; Hiroyoshi Yokoi; Elaine B Alajar; April Ann Bermudez-Delos Santos; Elmer Jasper B Llanes; Gay Marjorie Obrado-Nabablit; Noemi S Pestaño; Felix Eduardo Punzalan; Bernadette Tumanan-Mendoza Journal: J Atheroscler Thromb Date: 2020-07-04 Impact factor: 4.928
Authors: E Hope Weissler; Dennis I Narcisse; Jennifer A Rymer; Ehrin J Armstrong; Eric Secemsky; William A Gray; Jihad A Mustapha; George L Adams; Gary M Ansel; Manesh R Patel; W Schuyler Jones Journal: Vasc Endovascular Surg Date: 2020-10-23 Impact factor: 1.089