Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study.

OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction. METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded. RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC. CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.

Cost Effectiveness of Endovascular Revascularisation vs. Exercise Therapy for Intermittent Claudication Due to Iliac Artery Obstruction.

OBJECTIVE: To compare cost effectiveness of endovascular revascularisation (ER) and supervised exercise therapy (SET) as primary treatment for patients with intermittent claudication (IC) due to iliac artery obstruction. METHODS: Cost utility analysis from a restricted societal perspective and time horizon of 12 months. Patients were included in a multicentre randomised controlled trial (SUPER study, NCT01385774, NTR2648) which compared effectiveness of ER and SET. Health status and health related quality of life (HRQOL) were measured using the Euroqol 5 dimensions 3 levels (EQ5D-3L) and VascuQol-25-NL. Incremental costs were determined per allocated treatment and use of healthcare during follow up. Effectiveness of treatment was determined in quality adjusted life years (QALYs). The difference between treatment groups was calculated by an incremental cost utility ratio (ICER). RESULTS: Some 240 patients were included, and complete follow up was available for 206 patients (ER 111 , SET 95). The mean costs for patients allocated to ER were €4 031 and €2 179 for SET, a mean difference of €1 852 (95% bias corrected and accelerated [bca] bootstrap confidence interval 1 185 - 2 646). The difference in QALYs during follow up was 0.09 (95% bcaCI 0.04 - 0.13) in favour of ER. The ICER per QALY was €20 805 (95% bcaCI 11 053 - 45 561). The difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39 - 0.91), again in favour of ER. CONCLUSION: ER as a primary treatment, results in slightly better health outcome and higher QALYs and HRQOL during 12 months of follow up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of ER as primary treatment.

Outcomes of Conservative Treatment in Patients with Chronic Limb Threatening Ischaemia: A Systematic Review and Meta-Analysis.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease. International guidelines recommend arterial revascularisation in patients with CLTI. However, these patients are often fragile elderly people with significant comorbidities, whose vascular anatomy is not always suitable for open or endovascular revascularisation. Recent studies have suggested acceptable outcomes of conservative treatment. A systematic review of the available literature was conducted to obtain best estimates of outcomes of conservative treatment in patients with CLTI. DATA SOURCES: MEDLINE, Embase, and Cochrane Central. REVIEW METHODS: A systematic review and meta-analysis was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. MEDLINE, Embase, and Cochrane Central were searched from inception until September 2019. All studies reporting on outcomes of conservative treatment for CLTI were considered. Study selection, data extraction, and risk of bias assessment were done by two investigators independently. Risk of bias was evaluated with a modified version of the Cochrane tool for observational studies. Outcomes of interest were all cause mortality, major amputation, and amputation free survival (AFS) after at least 12 months of follow up. A random effects model was used for meta-analyses. RESULTS: Twenty-seven publications were included, consisting of 12 observational studies and 15 placebo arms from randomised clinical trials, totalling 1 642 patients. Most studies included patients with non-reconstructable CLTI. Overall study quality was moderate. The pooled 12 month all cause mortality rate in 14 studies comprising 1 003 patients was 18% (95% confidence interval [CI] 13 - 25, I2 = 73%). The pooled major amputation rate from 14 studies comprising 755 patients was 27% (95% CI 20 - 36, I2 = 65%) after one year, and pooled AFS rate after 12 months in 11 studies with 970 patients was 60% (95% CI 52 - 67, I2 = 75%). CONCLUSION: Conservative treatment for patients with CLTI may be considered and does not always result in loss of limb or patient demise. The results of this review can be used to inform patients with CLTI about conservative treatment as part of a shared decision making process.

Editor's Choice - The Prognostic Value of the WIfI Classification in Patients with Chronic Limb Threatening Ischaemia: A Systematic Review and Meta-Analysis.

OBJECTIVES: The Society for Vascular Surgery has proposed the Wound, Ischaemia, and foot Infection (WIfI) classification system as a prognostic tool for the one year amputation risk and the added value of revascularisation in patients with chronic limb threatening ischaemia (CLTI). This systematic review summarises the current evidence on the prognostic value of the WIfI classification system in clinical practice. DESIGN: Systematic review and meta-analysis following the PRISMA guidelines. MATERIALS: The Embase, MEDLINE, and Cochrane databases were searched up to June 2018. METHODS: All studies using the WIfI classification for patients with CLTI were eligible. Outcomes of interest were major amputation, limb salvage, and amputation free survival in relation to WIfI clinical stage. The methodological quality of studies was appraised with the Quality in Prognosis Studies (QUIPS) tool. If possible, data were pooled and analysed using a random effects model. Study selection, quality assessment, and data extraction were carried out by two authors independently. RESULTS: The search yielded 12 studies comprising 2669 patients, most of whom underwent endovascular or open revascularisation. Overall study quality was moderate. All but one were retrospective studies, including a variety of subpopulations of patients with CLTI, such as only haemodialysis dependent, diabetic or non-diabetic patients. The WIfI classification was derived from chart data or prospectively maintained databases, both documented before the WIfI classification was published. Estimated one year major amputation rates from four studies comprising 569 patients were 0%, 8% (95% CI 3-21%), 11% (95% CI 6-18%) and 38% (95% CI 21-58%), for WIfI stages I-IV, respectively. CONCLUSIONS: The likelihood of an amputation after one year in patients with CLTI increases with higher WIfI stages, which is important prognostic information. Prospective evaluations are needed to determine its role in clinical practice.