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Absence of Long-Term Benefit of Revascularization in Patients with Intermittent Claudication: Five-Year Results from the IRONIC Randomized Controlled Trial

Artikel i vetenskaplig tidskrift
Författare Henrik Djerf
Johan Millinger
Mårten Falkenberg
Lennart Jivegård
Mikael Svensson
Joakim Nordanstig
Publicerad i Circulation: Cardiovascular Interventions
Volym 13
Nummer/häfte 1
ISSN 1941-7640
Publiceringsår 2020
Publicerad vid Institutionen för medicin, avdelningen för samhällsmedicin och folkhälsa
Institutionen för kliniska vetenskaper, Avdelningen för radiologi
Institutionen för medicin, avdelningen för molekylär och klinisk medicin
Språk en
Länkar https://doi.org/10.1161/CIRCINTERVE...
Ämnesord cost-effectiveness, exercise, health, intermittent claudication, peripheral arterial disease, quality of life
Ämneskategorier Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi

Sammanfattning

© 2020 Lippincott Williams and Wilkins. All rights reserved. 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.

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