Myth vs. Evidence: what the literature really says about atherectomy
To address the perception of limited published data supporting the use of atherectomy to treat peripheral arterial disease (PAD),1 Medtronic partnered with Jeffrey Carr, MD; Ralf Langhoff, MD; and Eric Secemsky, MD, MSc, to conduct the most comprehensive review of atherectomy literature for peripheral endovascular interventions to date.
They set out to discover the:
- totality of the reported data for atherectomy
- level of rigor for the published evidence
- patient outcomes
Atherectomy is backed by robust clinical evidence
- Published evidence for atherectomy is extensive, with 305 original research articles published through May 2024, including high levels of evidence.2
- Atherectomy is effective for both above the knee (ATK) and below the knee (BTK), and in both chronic limb-threatening ischemia (CLTI) and claudication.3
- Atherectomy is effective in both calcified and noncalcified lesions with a trend toward lower target lesion revascularization (TLR) rates in severely calcified lesions.3
305
original research articles published through May 2024
Atherectomy is backed by robust clinical evidence
- Published evidence for atherectomy is extensive, with 305 original research articles published through May 2024, including high levels of evidence.2
- Atherectomy is effective for both above the knee (ATK) and below the knee (BTK), and in both chronic limb-threatening ischemia (CLTI) and claudication.3
- Atherectomy is effective in both calcified and noncalcified lesions with a trend toward lower target lesion revascularization (TLR) rates in severely calcified lesions.3
Clinical rigor: top-tier studies validate atherectomy use
The systematic literature review found the highest levels of evidence were represented, including meta-analyses, randomized trials and prospective, multicenter observational studies.
Atherectomy delivers favorable outcomes across key metrics
Atherectomy was associated with low rates of 12-month patency loss, target lesion revascularization (TLR), major amputation, and mortality, as well as low bailout stenting rates. These rates compare favorably to published meta-analysis rates for uncoated balloon angioplasty and drug-coated balloon without atherectomy.4–7
12-month safety and effectiveness based on disease severity3
Major amputation
Meta-analysis rates and 95% confidence intervals
- Very low amputation rates in ATK lesions (0.6%)
- Major amputation rates higher when CLTI prevalence is ≥ 50% and for BTK vs. ATK
- Amputation rates similar regardless of severe calcification
TLR
Meta-analysis rates and 95% confidence intervals
- TLR outcomes are similar across CLTI, claudicant, ATK, and BTK cohorts
- TLR rates are not worse in cohorts with a higher prevalence of severe calcification
Directional atherectomy (contemporary analysis, 2014–2024)8
The overall analysis shown on the first graph includes all device classes. The second graph shows the analysis for studies that evaluated only directional atherectomy. Results show patients treated with directional atherectomy had lower rates of TLR, amputation, mortality, and bailout stenting than the overall analysis.8
All atherectomy devices
Meta-analysis rates and 95% confidence intervals
Directional only
Meta-analysis rates and 95% confidence intervals
Nonredundant prospective and retrospective observational studies, including nonoverlapping claims/database analyses (e.g., Medicare, VQI). Case studies fewer than ten patients and meta-analyses excluded.
Related links
Related product
Treat above and below the knee with the HawkOne™ Directional Atherectomy System to restore blood flow by removing plaque in patients with peripheral arterial disease (PAD).