Two-Year Data Published From Swedish Study of Primary Stenting of the SFA in Intermittent Claudication

May 16, 2018—Primary stenting of the superficial femoral artery (SFA) in patients with intermittent claudication demonstrated durable effects on health-related quality of life (HRQOL) at 24 months in a Swedish randomized controlled trial. The findings were published by Hans I. V. Lindgren, MD, et al in CardioVascular and Interventional Radiology (2018;41:872–881).

This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents on HRQOL compared to best medical treatment (BMT) alone in patients with stable intermittent claudication caused by SFA disease.

As summarized in CardioVascular and Interventional Radiology, 100 patients with stable intermittent claudication caused by SFA disease treated with BMT were randomized to either the stent group (n = 48) or the control group (n = 52) of BMT alone. The primary outcome measure was HRQOL, assessed by 36-Item Short Form Health Survey (SF-36) and EuroQoL five dimensions (EQ-5D) at 24 months after treatment. Walking Impairment Questionnaire, ankle-brachial index (ABI), and walking distance were secondary outcomes.

The investigators reported a significantly better SF-36 physical component summary for the stenting group versus the control group (P = .024). Significant improvement was also seen for the stenting group versus the control group in physical domain scores such as physical function (P = .012), bodily pain (P = .002), general health (P = .037), and EQ-5D (P = .010). Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18 in the stent group [P < .001] vs from 0.63 ± 0.17 to 0.69 ± 0.18 in the control group [P = .036]) and walking distance (from 170 ± 90 to 616 ± 375 m in the stent group [P < .001] vs from 209 ± 111 to 331 ± 304 m in the control group [P = .006]) also improved significantly in intragroup comparisons.

In patients with intermittent claudication caused by lesions in the SFA, primary stenting compared with BMT alone was associated with significant improvements in HRQOL, ABI, and walking distance up to 24 months of follow-up, concluded the investigators in CardioVascular and Interventional Radiology.

In May 2017, the 12-month results were published by Dr. Lindgren et al in the European Journal of Vascular and Endovascular Surgery (2017;53:686–694).