Henrik Djerf1,2, Johan Millinger1,3, Mårten Falkenberg2, Lennart Jivegård4,3, Mikael Svensson5, Joakim Nordanstig1,3. 1. Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden. 2. Department of Radiology, Institute of Clinical Science (H.D., M.F.), Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden. 3. Department of Molecular and Clinical Medicine (J.M., L.J., J.N.), Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden. 4. HTA Centrum (Health Technology Assessment Center) Västra Götaland (L.J.), Sahlgrenska University Hospital, Gothenburg, Sweden. 5. Department of Public Health and Community Medicine (M.S.), Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
Abstract
BACKGROUND: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. METHODS: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to eitherrevascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. RESULTS: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). CONCLUSIONS: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.
RCT Entities:
BACKGROUND: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. METHODS: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. RESULTS: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). CONCLUSIONS: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.
Entities:
Keywords:
cost-effectiveness; exercise; health; intermittent claudication; peripheral arterial disease; quality of life
Authors: Caitlin W Hicks; Courtenay M Holscher; Peiqi Wang; Chen Dun; Christopher J Abularrage; James H Black; Kim J Hodgson; Martin A Makary Journal: JACC Cardiovasc Interv Date: 2021-03-22 Impact factor: 11.075