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PRIORITY: Revascularization fails to improve survival rate in poor-risk CLI
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In poor-risk patients with critical limb ischemia, the 1-year overall survival rate for those who underwent revascularization did not differ significantly from those who did not, according to data from the PRIORITY registry.
The researchers included 662 patients with CLI due to chronic severe ischemia who required assistance in their daily lives because of their disability in activities of daily living and/or impairment of cognitive function. Patients were enrolled from 37 centers in Japan between January 2014 and April 2015.
Revascularization was planned in all but 100 patients. In the revascularization group, 30 (5.3%) underwent surgical reconstruction, 521 underwent endovascular therapy alone (92.7%) and scheduled revascularization was not performed in 11 (2%) due to deteriorated general conditions after registration. Of all patients, 625 (94.4%) completed 1-year follow-up. The primary endpoint was 1-year survival rate.
Patients who were not scheduled for revascularization were older, frailer, had more impaired cognitive function and activities of daily living, and less frequently used cardio- and vasculoprotective medications than those scheduled for revascularization, according to the data.
Survival rates
At 1 year, 223 patients (33.7%) died. After propensity score matching, the 1-year all-cause mortality rate was not significantly different between the revascularization vs. nonrevascularization groups (55.9% vs. 51%, respectively; P = .12). However, the estimated 1-year amputation-free survival rate was higher in the revascularization group vs. the nonrevascularization group (44.3% vs. 36.8%; log-rank P = .02).
Similar results were observed after limiting the study population to patients whose ischemia was proven by ankle pressure, ankle-brachial pressure index or skin perfusion pressure, as well as after accounting for interinstitution variability.
Among patients who underwent revascularization and were alive for 1 year, activities of daily living measures did not differ significantly from those at study registration and were still poorer than those before onset of CLI. Quality-of-life measures at 1 year, however, were significantly better than at study registration.
The researchers also performed a risk stratification analysis to identify a subgroup in favor of revascularization. Results revealed a negative association between revascularization and mortality in a subgroup of patients without three risk factors — advanced age, HF and wound-free CLI — but not in the subgroup of patients with at least one risk factor. Additionally, the effect of revascularization on mortality differed according to the number of risk factors (P for interaction = .004).
Heterogenous population
“The current paper by Iida et al helps to clarify the murky water that obscures our understanding of CLI. Critically, this paper suggests that whereas revascularization likely imparts some benefits, the variability in patient characteristics and in revascularization methodologies prevents firm conclusions for a large heterogeneous group of CLI patients representative of that seen in clinical practice in regard to outcomes for limb salvage, [quality-of-life] metrics, and overall need for repeated procedures,” Ronald P. Caputo, MD, from SUNY Upstate Health Science Center and the cardiology division of St. Joseph’s Hospital in Syracuse, New York, and Lawrence A. Garcia, MD, from Tufts University School of Medicine and St. Elizabeth’s Medical Center in Boston, wrote in an accompanying editorial.
“It clearly suggests that the future of CLI may not be in the revascularization, but in the accurate delineation of the multiple subgroups of patients that make up the cohort we now define broadly as CLI,” they wrote. – by Melissa Foster
Disclosures: The PRIORITY study was sponsored by Boston Scientific Japan K.K., Hokushin Medical 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 researchers and Caputo report no relevant financial disclosures. Garcia reports noncompensated consulting for Abbott, Boston Scientific and Medtronic; research funding from Abbott and Medtronic; equity interest in CV Ingenuity, Essential Medical, Primacea, Scion Cardiovascular, Spirox, Syntervention and Tissue Gen; and founding Innovation Vascular Partners Consulting.
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