Swedish Study Evaluates Primary Stenting of the SFA in Intermittent Claudication

May 8, 2017—Twelve-month results were published from a study evaluating the impact of primary stenting of the superficial femoral artery (SFA) on health-related quality of life (HRQOL), ankle-brachial index (ABI), and walking distance in patients with intermittent claudication (IC). The findings were published by Hans Lindgren, MD, et al for the Swedish Endovascular Claudication Stenting Trialists in the European Journal of Vascular and Endovascular Surgery (EJVES; 2017;53:686–694).

As background, invasive treatment of IC caused by severe atherosclerotic stenosis or occlusion in the SFA is controversial. The objective of this controlled, randomized, multicenter study was to assess the impact on HRQOL of primary stenting with nitinol self-expanding stents compared with best medical therapy (BMT) alone in patients with stable IC caused by SFA disease.

As summarized in EJVES, 100 eligible patients from seven Swedish hospitals treated with BMT were randomized to either the stent (n = 48) or the control (n = 52) group. The primary outcome measure was change in HRQOL, as assessed by the 36-Item Short Form Health Survey (SF-36) and EuroQoL five dimensions (EQ5D) questionnaire, at 12 months after treatment. Improvement in the Walking Impairment Questionnaire (WIQ), ABI, and walking distance were secondary outcomes.

The investigators found significant improvements in HRQOL in the stent group as compared with the control group. Specifically, 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); and physical component summary, 6.5 points (P < .001). The EQ5D improved 0.14 points (P = .008), and the WIQ improved 22 points (P < .001). These domains were unchanged in the control group.

ABI improved from 0.58 ± 0.11 to 0.86 ± 0.19 (P < .001) in the stent group versus 0.63 ± 0.17 to 0.7 ± 0.2 (P = .005) in the control group. Walking distance improved from 171 ± 90 m to 613 ± 381 m (P < .001) in the stent group versus 209 ± 106 m to 335 ± 321 m (P = .012) in the control group. At 12 months, both the ABI (P < .001) and the walking distance (P = .001) were higher in the stent group, reported the investigators in EJVES.

The investigators concluded that at 12-month follow-up, the addition of primary stenting to BMT was associated with significant improvement in HRQOL, ABI, and walking distance in patients with IC caused by lesions in the SFA compared to BMT alone.

Also in EJVES, a commentary by Stavros K. Kakkos, MD, et al addresses the merits and limitations of the findings and notes that the Swedish Endovascular Claudication Stenting Trialists are planning to report 2- and 5-year follow-up data from this study (2017;52:695).