TY - JOUR
T1 - The FReedom from Ischemic Events - New Dimensions for Survival (FRIENDS) registry
T2 - Design of a prospective cohort study of patients with advanced peripheral artery disease
AU - Keo, Hong H.
AU - Duval, Sue
AU - Baumgartner, Iris
AU - Oldenburg, Niki C.
AU - Jaff, Michael R.
AU - Goldman, Jo Anne
AU - Peacock, James M.
AU - Tretinyak, Alexander S.
AU - Henry, Timothy D
AU - Luepker, Russell V
AU - Hirsch, Alan T.
N1 - Funding Information:
Dr. Keo received a grant (PBBEB-121067) from the Swiss National Science Foundation and a research grant from Abbott Vascular, Switzerland. Dr. Hirsch received a grant from Abbott Vascular, USA, to support registry development.
PY - 2013/12/19
Y1 - 2013/12/19
N2 - Background: Advanced lower extremity peripheral artery disease (PAD), whether presenting as acute limb ischemia (ALI) or chronic critical limb ischemia (CLI), is associated with high rates of cardiovascular ischemic events, amputation, and death. Past research has focused on strategies of revascularization, but few data are available that prospectively evaluate the impact of key process of care factors (spanning pre-admission, acute hospitalization, and post-discharge) that might contribute to improving short and long-term health outcomes. Methods/Design: The FRIENDS registry is designed to prospectively evaluate a range of patient and health system care delivery factors that might serve as future targets for efforts to improve limb and systemic outcomes for patients with ALI or CLI. This hypothesis-driven registry was designed to evaluate the contributions of: (i) pre-hospital limb ischemia symptom duration, (ii) use of leg revascularization strategies, and (iii) use of risk-reduction pharmacotherapies, as pre-specified factors that may affect amputation-free survival. Sequential patients would be included at an index " vascular specialist-defined" ALI or CLI episode, and patients excluded only for non-vascular etiologies of limb threat. Data including baseline demographics, functional status, co-morbidities, pre-hospital time segments, and use of medical therapies; hospital-based use of revascularization strategies, time segments, and pharmacotherapies; and rates of systemic ischemic events (e.g., myocardial infarction, stroke, hospitalization, and death) and limb ischemic events (e.g., hospitalization for revascularization or amputation) will be recorded during a minimum of one year follow-up.Discussion: The FRIENDS registry is designed to evaluate the potential impact of key factors that may contribute to adverse outcomes for patients with ALI or CLI. Definition of new " health system-based" therapeutic targets could then become the focus of future interventional clinical trials for individuals with advanced PAD.
AB - Background: Advanced lower extremity peripheral artery disease (PAD), whether presenting as acute limb ischemia (ALI) or chronic critical limb ischemia (CLI), is associated with high rates of cardiovascular ischemic events, amputation, and death. Past research has focused on strategies of revascularization, but few data are available that prospectively evaluate the impact of key process of care factors (spanning pre-admission, acute hospitalization, and post-discharge) that might contribute to improving short and long-term health outcomes. Methods/Design: The FRIENDS registry is designed to prospectively evaluate a range of patient and health system care delivery factors that might serve as future targets for efforts to improve limb and systemic outcomes for patients with ALI or CLI. This hypothesis-driven registry was designed to evaluate the contributions of: (i) pre-hospital limb ischemia symptom duration, (ii) use of leg revascularization strategies, and (iii) use of risk-reduction pharmacotherapies, as pre-specified factors that may affect amputation-free survival. Sequential patients would be included at an index " vascular specialist-defined" ALI or CLI episode, and patients excluded only for non-vascular etiologies of limb threat. Data including baseline demographics, functional status, co-morbidities, pre-hospital time segments, and use of medical therapies; hospital-based use of revascularization strategies, time segments, and pharmacotherapies; and rates of systemic ischemic events (e.g., myocardial infarction, stroke, hospitalization, and death) and limb ischemic events (e.g., hospitalization for revascularization or amputation) will be recorded during a minimum of one year follow-up.Discussion: The FRIENDS registry is designed to evaluate the potential impact of key factors that may contribute to adverse outcomes for patients with ALI or CLI. Definition of new " health system-based" therapeutic targets could then become the focus of future interventional clinical trials for individuals with advanced PAD.
KW - Amputation
KW - Atherosclerosis
KW - Health service research
KW - Outcomes research
KW - Peripheral artery disease
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U2 - 10.1186/1471-2261-13-120
DO - 10.1186/1471-2261-13-120
M3 - Article
C2 - 24354507
AN - SCOPUS:84890351704
SN - 1471-2261
VL - 13
JO - BMC Cardiovascular Disorders
JF - BMC Cardiovascular Disorders
M1 - 120
ER -
