Background: The efficacy and safety of contemporary self-expanding bare metal Nitinol stents (NS) compared to primary Percutaneous Transluminal Angioplasty (PTA) in the treatment of above-knee femoropopliteal atherosclerotic disease is still controversial.
Objective: We sought to evaluate the immediate (procedural success) and intermediate (rate of restenosis and target lesion/vessel revascularization (TLR/TVR) at 1 year) clinical outcomes of primary NS implantation versus primary PTA with bailout stenting in the treatment of above-knee femoropopliteal disease by conducting a meta-analysis of the available randomized controlled trials (RCT).
Methods: We searched Medline and Cochrane databases from 1990 to 2014. Risk ratios (RR) and 95% confidence intervals (CI) were calculated using random-effects model.
Results: Six RCTs with a total of 827 patients (NS = 443, PTA = 384; average age 68.5 years, males = 562, average lesion length = 8.7cm in NS and 7.7cm in PTA) were analyzed on intention to treat basis. The immediate procedural success rate was significantly better in the NS group (96% vs 75%; RR= 1.26; 95% CI, 1.15-1.38) as well as restenosis rate at 1 year (30.8% vs 51.2%; RR=1.63; 95% CI, 1.11-2.38) compared to primary PTA. TLR/TVR rates at 1 year were lower in the NS group (15.5% vs 28.1%; RR=1.77; 95% CI, 0.90-3.49), but the difference did not reach the statistical significance. Four patients in each group had amputations during follow-up. Two studies noticed a 3% and 12% incidence of stent fractures.
Conclusions: While there is immediate clinical benefit of acute procedural success associated with primary Nitinol stent implantation as compared to PTA with bailout stenting in patients with femoropopliteal atherosclerotic disease, this salutary effect may be partially offset by statistically non-significant difference in incidence of target lesion revascularization at 1 year. Such a risk-benefit assessment should be carefully considered in all patients.