Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial.

BACKGROUND: Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease.

METHODS: One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes.

RESULTS: HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p < .001); Bodily Pain, 14 points (p = .001); General Health, 6 points (p = .019); Vitality, 10 points (p = .004); Physical Component Summary, 6.5 points (p < .001); EQ5D, 0.14 points (p = .008); and WIQ 22 points (p < .001). They were unchanged in the control group. Both ABI (from 0.58 ± 0.11 to 0.86 ± 0.19, p < .001, in the stent group and from 0.63 ± 0.17 to 0.70 ± 0.20, p = .005, in the control group) and walking distance (WD) (from 171 ± 90 meters to 613 ± 381 meters, p < .001, in the stent group and from 209 ± 106 m to 335 ± 321 meters, p = .012, in the control group) improved, and at 12 months both the ABI (p < .001) and the WD (p = .001) were higher in the stent group.

CONCLUSIONS: In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.