Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment. METHODS: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. RESULTS: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY. CONCLUSION: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.

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

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.

Low Risk of Procedure Related Major Amputation Following Revascularisation for Intermittent Claudication: A Population Based Study.

OBJECTIVE: To investigate the risk of procedure-related major amputation attributable to revascularization for intermittent claudication (IC) in a population-based observational cohort study. METHODS: All patients who underwent open or endovascular lower limb revascularisation for IC in Sweden between 12 May 2008 and 31 December 2012 were identified from the Swedish National Quality Registry for Vascular Surgery (Swedvasc) and data on above ankle amputations were extracted from the National Patient Registry. Any uncertainty regarding amputation level and laterality was resolved by reviewing medical charts. For the final analysis, complete medical records of all patients with IC, having ipsilateral amputation after the revascularisation procedure, were reviewed. Patients wrongly classified as having IC were excluded. Ipsilateral amputations within one year of the revascularisation were defined as procedure related. RESULTS: Altogether, 5 860 patients revascularised for IC were identified of whom 109 were registered to have undergone a post-operative ipsilateral lower limb amputation during a median follow up of 3.9 years (standard deviation 1.5 y). Seventeen were duplicate registrations and 51 were patients with chronic limb threatening ischaemia, misclassified as IC in the registry. One patient had not undergone any revascularisation, one was revascularised for a popliteal artery aneurysm, one was revascularised for acute limb ischaemia, one had a minor amputation only, and one patient was not amputated at all. Twenty-seven were amputated more than one year after the procedure. Thus, the major amputation rate within one year of revascularisation for IC was 0.2% (n = 9/5 860). CONCLUSION: Revascularisation for IC in a contemporary setting confers a low but existing risk of procedure related major amputation within the first post-procedural year.

Re-interventions after endovascular aortic repair for infrarenal abdominal aneurysms: a retrospective cohort study.

BACKGROUND: Early morbidity and mortality are generally lower after endovascular aortic repair (EVAR), than after open repair but re-interventions and late complications are more common. The aim of the present study was to make a detailed description of re-interventions after EVAR-including incidence, indications, procedures, and outcome-with special reference to non-access-related re-interventions. METHODS: This is a retrospective single-center cohort study of re-interventions after standard EVAR with special reference to non-access-related re-interventions. Consecutive patients (n = 405) treated with standard EVAR for non-ruptured (n = 337) or ruptured (n = 68) infrarenal aneurysms between 2005 and 2013 were analysed. Median follow-up was 29 months (range 0-108). RESULTS: Eighty-nine patients (22 %) underwent 113 re-interventions during follow-up. Twenty-seven patients (7 %) had 28 access related re-intervention, 65 patients (16 %) had 85 non-access related reinterventions. Non-access related re-interventions were more common in ruptured aneurysms than in unruptured aneurysms (22 vs. 15 %, p = 0.002). The most frequent indications were endoleak type I (n = 19), type II (n = 21), or type III (n = 5); stent graft migration (n = 9); and thrombosis (n = 14). The most frequent procedures were embolization of endoleak type II (n = 21), additional iliac stent graft (n = 19), proximal extension (n = 12), thrombolysis (n = 8), iliac limb bare-metal stenting (n = 6), and stent graft relining (n = 7). Endovascular technique was used in 83 % of re-interventions. Thirty-day mortality after non-access-related re-interventions was 15 % when initiated from symptoms (rupture or infection) and 0 % when initiated from follow-up findings (p = 0.014). Cumulative survival five years after EVAR was 72 % in patients with a re-intervention and 59 % in patients without (p = 0.21). CONCLUSIONS: Non-access-related re-intervention rates are still considerable after EVAR and more frequent after ruptured aneurysms. Endoleak embolization is the most frequent procedure, followed by additional iliac stent grafts. Outcomes after re-interventions are generally good, except when initiated by rupture or infection.