Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

• Background Intermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL). Methods One hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle-brachial index (ABI), and walking distance were secondary outcomes. Results Significantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 +/- 0.11 to 0.85 +/- 0.18; P < 0.001 in the stent group and from 0.63 +/- 0.17 to 0.69 +/- 0.18; P = 0.036 in the control group) and walking distance (from 170 +/- 90 m to 616 +/- 375 m; P < 0.001 in the stent group and from 209 +/- 111 m to 331 +/- 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons. Conclusions In patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Radiologi och bildbehandling (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Radiology, Nuclear Medicine and Medical Imaging (hsv//eng)

Nyckelord

Peripheral arterial disease

Intermittent claudication

Primary stenting

Health-related quality of life

percutaneous transluminal angioplasty

paclitaxel-eluting stents

supervised exercise

clinical-trial

follow-up

femoropopliteal artery

balloon angioplasty

coated balloon

disease

revascularization

Cardiovascular System & Cardiology

Radiology

Medical Imaging

Superficial femoral artery

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