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Nordanstig J, Gelin J, Hensäter M, et al. Walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication – prospective randomised trial. Eur J Vasc Endovasc Surg 2011; 42(2): 220-27.
In a nutshell
This is a prospective randomised controlled trial comparing the outcomes at two years of primary invasive revascularisation and unsupervised exercise (INV) versus unsupervised exercise alone (NON) for intermittent claudication. Strict inclusion criteria (including age not lower than 85, no other disorders limiting walking performance, having a treatable lesion identified on Doppler) were applied. Two hundred and one patients were randomised in the two groups using methodology which minimised any inter-group variability. All patients were given aspirin, helped to stop smoking and had their diabetes, hypertension and hyperlipidaemia treated.
All patients also received verbal and written advice on an unsupervised training programme. Patients in the INV limb were then treated using either endovascular or surgical techniques as deemed best. Patients were followed up at 6, 12 and 24 months.
The primary outcome measure was maximal walking performance (MWP) on a graded treadmill with an increasing workload. Secondary outcome measures were ankle-brachial index (ABI) changes and health-related quality of life (HRQL) changes. There was no difference in maximal walking performance between the two groups (p= 0.104). Patients in the INV group showed significant improvement in two of the eight HRQLs domains assessed compared with the NON group.
Second opinion
This randomised controlled trial compares invasive treatment and unsupervised exercise versus unsupervised exercise alone for intermittent claudication. The findings of this study showed no significant difference between the two groups in MWP which was the main outcome measure. This despite the fact that supervised exercise which has been shown to be better than unsupervised exercise at improving walking measures was not used.
Use of statins was not widespread in this cohort despite the fact that this is recommended in patients with peripheral arterial disease. The authors report that 30% had elevated serum cholesterol and two-thirds of these had lipid lowering treatment. Statins have also been shown to increase walking distance in claudicants and higher use of statins in this study may have resulted in improved MWP in the control group. It is unclear from the paper what proportion of the participants were receiving optimal medical treatment. Only 80% of the INV group and 91% of the NON group received their allocated treatment. The short form SF36 was the HRQL tool used. No disease specific HRQL tools were used. At 24 months only 79% of the total group was followed up.
The verdict
- In intermittent claudication invasive treatment offers no significant improvement in maximal walking performance at 24 months.
Christian Camenzuli
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Kevin Cassar
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