Drug Eluting Stents Below the Knee: Patency, Amputation-Rate, and Mortality-A Systematic Review of the Literature.

Abstract

Background: Numerous meta-analyses and multicenter randomized controlled trials have demonstrated that drug-eluting stents (DES) offer superior outcomes in terms of primary patency and limb salvage compared to other endovascular modalities such as balloon angioplasty and bare metal stents. This review aims to systematically analyze the literature on the clinical outcomes of DES for the treatment of infrapopliteal arterial occlusions.

Methods: This study is a systematic review. Comprehensive searches were conducted in the MEDLINE, EMBASE, Ovid, Cochrane, DAR, and BVS databases. Eligible studies were those that reported outcomes of DES in the treatment of infrapopliteal arterial disease, with no restrictions on time frame, publication status, or language. The primary outcome assessed was the primary patency of the stent, while secondary outcomes included the rates of re-occlusion and mortality.

Results: A total of 27 studies involving 2470 patients were included in the analysis, in which 1191 patients come from prospective multicenter studies. The mean age of the participants was 73.4 years. Approximately, 50% of the patients had diabetes mellitus and/or chronic renal failure, and 33.3% had heart disease. The fibular artery was the most frequently affected by stenosis, involved in 50.2% of cases, followed by the anterior tibial artery in 34.6% of cases and the posterior tibial artery in 15.2% of cases. The average patency rate following DES treatment was 72.2% at 12 months. The rate of re-occlusion was 21.6%, and the mortality rate was 16.6%. However, due to the heterogeneity of the sample and incomplete data, it was not possible to draw definitive correlations between patency, amputation rates, and mortality.

Conclusion: This systematic review and analysis revealed significant limitations due to the heterogeneity of the sample and incomplete data, preventing a comprehensive stratification of the findings. As a result, we are not yet able to fully address the research questions posed. Further studies with extended follow-up periods are needed to standardize the treatment of infrapopliteal arterial occlusions and provide more definitive conclusions.Clinical ImpactThis review assessed the efficacy and safety of drug-eluting stents for below-the-knee lesions, showing promising patency and safety results. Their use in daily practice may aid in treating lesions prone to recoil and dissection after angioplasty. Despite some data inconsistencies, the findings remain encouraging. Drug-eluting stents demonstrated better outcomes than Bare-metal Stent, supporting their consideration in clinical practice for below-the-knee vascular treatment.