A systematic review and meta-analysis of more than 300 original investigations on atherectomy in peripheral arterial disease (PAD) highlights “overall favourable” clinical outcomes. This and other findings from what researchers say is the first investigation to provide a “comprehensive” overview of the atherectomy literature were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) and presented at the 2025 VEITHsymposium (18–22 November, New York, USA).
“Although atherectomy for peripheral interventions has been studied for over 35 years, recent criticisms suggest it lacks supportive evidence,” the researchers, led by co-first authors Jeffrey Carr (Christus Health Heart and Vascular Institute, Tyler, USA), Ralf Langhoff (Humboldt University Berlin, Berlin, Germany) and Eric Secemsky (Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA) write. As a result, Carr and colleagues set out to provide an “intentionally broad overview” of both the quality of the “extensive” published literature on atherectomy and the procedure’s clinical outcomes.
The research team conducted a systematic review of original research published in MEDLINE, Embase, and PubMed through November 2024, identifying both prospective and retrospective studies on atherectomy for infrainguinal peripheral artery interventions. They note that while case studies and meta-analyses were included in the systematic review, these study types were excluded from the quantitative meta-analysis.
Carr and colleagues specify that study design, device class, patient and lesion characteristics, provisional stenting, distal embolisation, and 12-month outcomes—namely patency, major amputation, target lesion revascularisation, and mortality—were captured.
In JSCAI, the authors share that their systematic review included 322 published atherectomy papers comprising 121 directional, 44 laser, 30 orbital, 72 rotational, and 55 mixed atherectomy classes. They note that the designs were meta-analyses in 3.7% (12 papers), randomised 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). Additionally, they state that adjunctive therapies were used in 91.5% and 29.2% were included in a comparator arm.
Carr and colleagues report that, among 190 papers included in their meta-analysis, the 12-month patency, target lesion revascularisation, major amputation, and mortality rates were 75.4% (51 studies), 15.6% (67 studies), 1.7% (71 studies), and 2.8% (63 studies), respectively. Furthermore, they report that the distal embolisation rate was 2.2% (159 studies) and the provisional stenting rate, 9.3% (131 studies). “Considerable heterogeneity was observed,” the authors write.
Acknowledging some limitations of their paper, Carr and colleagues recognise that a lack of data prevented the assessment of longer-term follow-up data beyond the five-year mark. In addition, they accept their review is restricted in its ability to compare classes of atherectomy devices across studies and is “unable to provide firm conclusions” regarding the outcomes of atherectomy as a standard procedure, given that the majority of included studies used adjunctive therapies, among other drawbacks.
Carr and colleagues summarise in their conclusion that the present analysis highlights low rates of amputation, mortality, provisional stenting, and distal embolisation with atherectomy and demonstrates an absence of safety signals and efficacy rates that are within accepted standards. They remark that the investigation “supports the use of atherectomy in appropriately selected patients as part of the endovascular treatment algorithm for [PAD]”.
Looking ahead, the authors suggest future trials should address the impact of plaque modification with atherectomy in the context of evolving drug delivery solutions with drug-coated balloons, drug-eluting stents, and bioabsorbable devices.
“As atherectomy devices continue to evolve, it is important to support newer technology with trials, registries, and other evidence-generation means,” the authors suggest, considering future research in this space. They also highlight the importance of evaluating the cost-effectiveness and accretive value of atherectomy outcomes with longer-term studies.
Carr and colleagues note in their JSCAI paper that this work was supported by Medtronic.
