Published Evidence on Peripheral Atherectomy: A Meta-analysis and Systematic Literature Review of More Than 300 Original Investigations.
Review
Overview
abstract
BACKGROUND: Although atherectomy for peripheral interventions has been studied for over 35 years, recent criticisms suggest it lacks supportive evidence. This analysis provides a comprehensive overview of the quality and outcomes in the published atherectomy literature. METHODS: A systematic review of original research published in MEDLINE, Embase, and PubMed through November 2024 identified prospective and retrospective studies on atherectomy for infrainguinal peripheral artery interventions. Case studies and meta-analyses were included in the systematic review but excluded from the quantitative meta-analysis. Risk of bias was assessed using validated scales. Study design, device class, patient/lesion characteristics, provisional stenting, distal embolization, and 12-month outcomes (patency, major amputation, target lesion revascularization, and mortality) were captured. RESULTS: The systematic review included 322 published atherectomy papers (121 directional, 44 laser, 30 orbital, 72 rotational, 55 mixed atherectomy classes). Designs were meta-analyses in 3.7% (12 papers), randomized controlled trials in 5.9% (19 papers), prospective observational studies in 29.8% (96 papers), retrospective observational studies in 45.7% (147 papers), and case studies in 14.9% (48 papers). Adjunctive therapies were used in 91.5%, and 29.2% included a comparator arm. Among 190 papers included in the meta-analysis, the 12-month patency, target lesion revascularization, major amputation, and mortality rates were 75.4% (51 studies), 15.6% (67 studies), 1.7% (71 studies), and 2.8% (63 studies), respectively. The distal embolization rate was 2.2% (159 studies), and the provisional stenting rate was 9.3% (131 studies). Considerable heterogeneity was observed. CONCLUSIONS: Extensive published literature exists for peripheral atherectomy, including high levels of evidence. Clinical outcomes were overall favorable with low rates of amputation, mortality, provisional stenting, and distal embolization. This intentionally broad review was associated with considerable heterogeneity and should be confirmed with appropriate comparative studies.
