Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication

Nordanstig, Joakim; Taft, Charles; Hensäter, M.; Perlander, Angelica; Österberg, Klas; Jivegård, Lennart

doi:10.1002/bjs.10198

Cited by 23 publications

(10 citation statements)

References 43 publications

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“…As reported previously 13 , a revascularization strategy in addition to BMT improved HRQoL compared with BMT alone. The time trend in self-assessed HRQoL scored on a scale from 0 to 1 demonstrated a larger increase in health status in the revascularization group than in the BMT-alone group (Fig.…”

Section: Health Outcomessupporting

confidence: 80%

“…In the revascularization + BMT group, 70 of 79 patients (89 per cent) received invasive treatment. Reasons for not receiving invasive treatment were improvement in symptoms while waiting for the invasive procedure (6 patients), non-significant stenosis on digital subtraction angiography (2) and poor run-off requiring distal bypass (1 13,14 .…”

Section: Resultsmentioning

confidence: 99%

“…An important limitation was that patients were not enrolled in a formal SET, but were instead given structured exercise advice, which was verified and reinforced at regular intervals. SET is generally regarded as being more effective 13 . SET is not widely available, however, and most patients in Europe are therefore offered non-supervised exercise.…”

Section: Discussionmentioning

confidence: 99%

“…The IRONIC trial was a single-centre, open-label, prospective randomized trial comparing revascularization in addition to best medical treatment (revascularization + BMT group) with best medical treatment alone (BMT-alone group), performed in the academic vascular surgery department of Sahlgrenska University Hospital, Gothenburg, Sweden. The study design and clinical effectiveness endpoints have already been reported 13,14 . The study has been registered in the ClinicalTrials.gov database (NCT01219842).…”

Section: Methodsmentioning

confidence: 99%

“…All patients received medical management, which was started directly after randomization. This included a voluntary smoking cessation programme and secondary preventive pharmacotherapy (antiplatelet and statin therapy); hypertension and diabetes were treated according to recommendations in current guidelines 13 . All patients received verbal and written information about PAD.…”

Section: Methodsmentioning

confidence: 99%

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Cost-effectiveness of revascularization in patients with intermittent claudication

Djerf

Falkenberg

Jivegård

et al. 2018

British Journal of Surgery

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Background Revascularization is a treatment option for patients with intermittent claudication. However, there is a lack of evidence to support its long‐term benefits and cost‐effectiveness. The aim of this study was to compare the cost‐effectiveness of revascularization and best medical therapy (BMT) with that of BMT alone. Methods Data were used from the IRONIC (Invasive Revascularization Or Not in Intermittent Claudication) RCT where consecutive patients with mild‐to‐severe intermittent claudication owing to aortoiliac or femoropopliteal disease were allocated to either BMT alone (including a structured, non‐supervised exercise programme) or to revascularization together with BMT. Inpatient and outpatient costs were obtained prospectively over 24 months of follow‐up. Mean improvement in quality‐adjusted life‐years (QALYs) was calculated based on responses to the EuroQol Five Dimensions EQ‐5D‐3 L™ questionnaire. Cost‐effectiveness was assessed as the cost per QALY gained. Results A total of 158 patients were randomized, 79 to each group. The mean cost per patient in the BMT group was €1901, whereas it was €8280 in the group treated with revascularization in addition to BMT, with a cost difference of €6379 (95 per cent c.i. €4229 to 8728) per patient. Revascularization in addition to BMT resulted in a mean gain in QALYs of 0·16 (95 per cent c.i. 0·06 to 0·24) per patient, giving an incremental cost‐effectiveness ratio of €42 881 per QALY. Conclusion The costs associated with revascularization together with BMT in patients with intermittent claudication were about four times higher than those of BMT alone. The incremental cost‐effectiveness ratio of revascularization was within the accepted threshold for public willingness to pay according to the Swedish National Guidelines, but exceeded that of the UK National Institute for Health and Care Excellence guidelines.

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Section: Health Outcomessupporting

confidence: 80%