Purpose: To review emerging evidence regarding the use of bare metal (BMS) vs. drug-eluting stents (DES) in the treatment of infrapopliteal occlusive disease.
Methods: A systematic review of the literature was undertaken to identify all studies comparing stent treatments of infragenicular vessels in patients with chronic lower limb ischemia. Validated methods to assess the methodological quality of the included studies were applied. Outcome data were pooled, and combined overall effect sizes were calculated using fixed or random effects models. The search identified 4 randomized clinical trials and 2 observational studies reporting on 544 patients (287 treated with DES and 257 treated with BMS). Data are presented as the odds ratio (OR) with 95% confidence interval (CI) and the number-needed-to-treat (NNT).
Results: Primary patency, freedom from target lesion revascularization, and clinical improvement at 1 year were significantly higher in the DES recipients compared to patients treated with BMS (OR 4.511, 95% CI 2.897 to 7.024, p<0.001, NNT 3.5; OR 3.238, 95% CI 2.019 to 5.192, p<0.001, NNT 6.0; and OR 1.792, 95% CI 1.039 to 3.090, p=0.036, NNT 7.3, respectively). No significant differences in limb salvage and overall survival at 1 year were identified between the groups (OR 2.008, 95% CI 0.722 to 5.585, p=0.181; OR 1.262, 95% CI 0.605 to 2.634, p=0.535, respectively). Sensitivity analyses investigating the potential effects of study design and type of DES on the combined outcome estimates validated the results.
Conclusion: Our analysis has demonstrated superior short-term results with DES compared with BMS, expressed by increased patency and freedom from target lesion revascularization. The influence of this finding on clinical surrogate endpoints, such as limb salvage, remains unknown.