Author + information
- Received December 16, 2016
- Revision received February 22, 2017
- Accepted March 9, 2017
- Published online June 5, 2017.
- Osamu Iida, MDa,∗ (, )
- Mitsuyoshi Takahara, MD, PhDb,
- Yoshimitsu Soga, MDc,
- Nobuyoshi Azuma, MD, PhDd,
- Shinsuke Nanto, MD, PhDe,
- Masaaki Uematsu, MD, PhDa,
- PRIORITY Investigators
- aCardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
- bDepartment of Diabetes Care Medicine, and Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan
- cDepartment of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
- dDepartment of Vascular Surgery, Asahikawa Medical University, Asahikawa, Japan
- eDepartment of Cardiology, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan
- ↵∗Address for correspondence:
Dr. Osamu Iida, Kansai Rosai Hospital, Cardiovascular Center, 3-1-69 Inabaso, Amagasaki, Hyogo 660-8511, Japan.
Objectives The authors sought to investigate the prognostic impact of revascularization for poor-risk CLI patients in real-world settings.
Background Critical limb ischemia (CLI) is often accompanied with various comorbidities, and frailty is not rare in the population. Although previous studies suggested favorable outcomes of revascularization for CLI patients, those studies commonly included the healthier, that is, less frail patients.
Methods This was a multicenter prospective observational study, registering patients who presented with CLI and who required assistance for their daily lives because of their disability in activities of daily living (ADL) and/or impairment of cognitive function. Revascularization was either planned (revascularization group) or not planned (non-revascularization group). The primary endpoint was 1-year survival, and was compared between the revascularization and non-revascularization groups, using the propensity score-matching method.
Results Between January 2014 and April 2015, a total of 662 patients were registered, of those 100 non-revascularization patients were included. A total of 625 patients (94.4%) completed the 1-year follow-up. Death was observed in 223 patients (33.7%). After propensity score matching, the 1-year survival rate was 55.9% in the revascularization group versus 51.0% in the non-revascularization group, with no significant difference (p = 0.120). In the subgroups alive at 1 year after revascularization, health-related quality of life was significantly improved compared with baseline, whereas ADL scores were unchanged from baseline and still remained significantly worse than before CLI onset.
Conclusions The 1-year overall survival rate was not significantly different between the revascularization and non-revascularization groups in poor-risk CLI patients. (Poor-Risk Patients With and Without Revascularization Therapy for Critical Limb Ischemia; [PRIORITY Registry]; UMIN000012871)
The PRIORITY study is sponsored by the following companies (in alphabetical order): Boston Scientific Japan K.K., HOKUSHINMEDICAL Co., Ltd., Japan, Orbusneich Foundation, Johnson & Johnson K.K., Medicon Inc., Medtronic Japan Co., Ltd, MSD K.K., Otsuka Pharmaceutical Co., Ltd., Terumo Corp., and W.L. Gore & Associates, Co., Ltd. The funding companies played no role in the design of the study, selection of the enrolled patients, treatment strategy, revascularization procedures or equipment, or the collection, analysis, or interpretation of the data. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 16, 2016.
- Revision received February 22, 2017.
- Accepted March 9, 2017.
- 2017 American College of Cardiology Foundation