A Cochrane review included 11 studies with a total of 1387 subjects. Participants were followed for up to two years. There was an improvement in primary duplex patency at six and 12 months in participants treated with PTA plus stent over lesions treated with PTA alone (six months: odds ratio (OR) 2.90, 95% confidence interval (CI) 1.17 to 7.18, P = 0.02, six studies, 578 participants; 12 months: OR 1.78, 95% CI 1.02 to 3.10, P = 0.04, nine studies, 858 participants). This was lost by 24 months (P = 0.06). There was a significant angiographic patency benefit at six months (OR 2.49, 95% CI 1.49 to 4.17, P = 0.0005, four studies, 329 participants) which was lost by 12 months (OR 1.30, 95% CI 0.84 to 2.00, P = 0.24, five studies, 384 participants). Ankle brachial index (ABI) and treadmill walking distance showed no improvement at 12 months (P = 0.49 and P = 0.57 respectively) between participants treated with PTA alone or PTA with stent insertion. Three trials (660 participants) reported quality of life, which showed no significant difference between participants treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria regarding affected arteries between trials showed marked heterogeneity.
A similar but lesser effect was seen for ankle brachial pressure index (ABPI) (MD at 12 months 0.07, 95% CI 0.05 to 0.09; 3 studies, n=291), while a more pronounced improvement in treadmill walking distance in patients with PTA plus stent insertion was observed at six and 12 (MD 62.52 metres, 95% CI 48.36 to 76.68; 2 studies, n=240) but not 24 months. Only one trial reported quality of life, which showed no significant difference between patients treated with PTA alone or PTA with stent insertion at any time interval (MD at 6 months -1.13, 95% CI -5.03 to 2.77; 1 study, n=208 and MD at 12 months 0.96, 95% CI -2.62 to 4.53; 1 study, n=208).Comment: The quality of evidence is downgraded by inconsistency (variability in results across studies) and by indirectness (clinical findings, especially patient quality of life did not improve; protocols between trials varied, and the benefit may be limited to patients with superficial femoral artery disease subsequently treated with long term clopidogrel).