Peripheral artery disease (PAD) affects more than 12 million Americans and is a leading cause of limb loss and cardiovascular mortality.¹ Atherectomy – the mechanical removal of atherosclerotic plaque – has emerged as an important adjunct to balloon angioplasty, stenting and drug delivery systems, offering improved luminal gain while minimizing vessel trauma. This review summarizes device platforms approved by the U.S. Food and Drug Administration (FDA), supporting evidence and unmet needs.

What Is Atherectomy?

Atherectomy employs catheter-based cutting, photoablation or rotational ablative mechanisms to debulk obstructive plaque prior to adjunctive therapy. By modifying lesion compliance and removing plaque volume – particularly in calcified or fibrotic segments – atherectomy aims to optimize drug-coated balloon (DCB) drug uptake, reduce elastic recoil, minimize flow limiting dissections and lower bailout stent rates.² Maximal lumen gain is associated with improved patency outcomes.³ Four broad modalities are in clinical use: directional, rotational/excisional, orbital and laser photoablation; several of these devices incorporate aspiration to reduce risk of embolization.

Evidence Summary

The evidence base for atherectomy dates back to1988 and spans randomized controlled trials (RCTs), prospective studies, registries and real-world datasets.⁴

Directional atherectomy was shown to deliver high primary patency (78% in claudicants) with low target lesion revascularization (TLR) rates of approximately 12% at one year in the DEFINITIVE LE trial.⁵ Laser atherectomy plus percutaneous transluminal angioplasty (PTA) significantly reduced six-month TLR, vs. PTA alone, in patients with femoropopliteal in‑stent restenosis in EXCITE ISR.⁶ Rotational atherectomy with aspiration achieved effective debulking and favorable patency in complex femoropopliteal lesions, including calcified and occlusive disease in PATHWAY PVD.⁷

Two randomized trials – COMPLIANCE 360 in femoropopliteal disease and CALCIUM 360 in infrapopliteal disease – demonstrated that orbital atherectomy plus balloon angioplasty reduced bailout stenting rates and balloon inflation pressures vs. angioplasty alone in calcified lesions, as well as identified residual stenosis >30% as an independent predictor of adverse outcomes.^8,9

A prospective registry, LIBERTY 360, reported two-year primary patency of 89.7% in claudicants and three-year freedom from major amputation of 88.6% in patients with critical limb ischemia, supporting an atherectomy-based approach across the full spectrum of PAD severity.¹⁰

Atherectomy may enhance DCB efficacy by modifying the lesion substrate and improving drug uptake. A 2025 network meta-analysis found atherectomy plus DCB was associated with higher technical success and 12-month patency rates vs. DCB alone for femoropopliteal interventions supporting plaque modification as a key strategy in complex PAD.¹¹

A 2025 comprehensive systematic literature review and meta-analysis evaluated 322 atherectomy publications including 19 RCTs and reported pooled 12-month patency of 75.4%, TLR of 15.6% and major amputation of 1.7% – concluding atherectomy outcomes are favorable while calling for appropriately powered comparative trials.⁴

Device Selection

Although most devices treat multiple lesional morphologies, no single device is superior for all subtypes (see Table 1). Device selection should be guided by lesion characteristics with the aim of achieving maximal luminal gain while minimizing deep wall injury and vessel barotrauma.

Unmet Needs and Questions Remaining

Several fundamental clinical questions remain. Does atherectomy improve drug delivery and durability for DCBs, drug-eluting stents and bioresorbable scaffolds – and if so, in which lesion subsets? Is the benefit device-specific or a class effect? What degree of plaque removal is optimal by lesion type and morphology?

The emergence of intravascular lithotripsy (IVL) also raises key questions. Does IVL complement atherectomy in severely calcified lesions, serve as a standalone alternative or is it preferred based on defined morphologies – concentric, deep or nodular calcium – where atherectomy alone may be insufficient? Do outcomes justify the cost burden these devices impose?

There is also need for standardized device selection algorithms across lesion subsets to achieve consistent outcomes, alongside structured training pathways for less experienced practitioners.

The heterogeneity of peripheral arterial lesions limits generalizability across atherectomy device categories and poses challenges for comparative effectiveness studies. Until appropriately powered, head-to-head randomized trials are conducted – particularly for infrapopliteal disease and chronic limb-threatening ischemia – device selection will rely on prospective studies, registry data, operator experience and expert consensus rather than level 1 evidence.

Conclusion

Atherectomy is well-supported within a multimodality endovascular approach to complex PAD, with device selection guided by lesion morphology. As the field evolves to include IVL and advanced drug delivery platforms, defining atherectomy's optimal role through well-designed comparative trials will be beneficial to delivering consistent, durable outcomes across the full spectrum of disease.

References

1. Allison MA, Armstrong DG, Goodney PP, et al.; American Heart Association Council on Peripheral Vascular Disease. Health disparities in peripheral artery disease: A Scientific Statement From the American Heart Association. Circulation. 2023;148(3):286-296..
2. Bhat TM, Afari ME, Garcia LA. Atherectomy in Peripheral Artery Disease: A Review. J Invasive Cardiol. 2017;29(4):135-144.
3. Krishnan P, Farhan S, Schneider P, et al. Determinants of drug-coated balloon failure in patients undergoing femoropopliteal arterial intervention. J Am Coll Cardiol. 2022;80(13):1241-1250.
4. Carr JG, Langhoff R, DeRubertis BG, et al. Published evidence on peripheral atherectomy: A meta-analysis and systematic literature review of more than 300 original investigations. J Soc Cardiovasc Angiogr Interv. 2025;4(11):104009.
5. McKinsey JF, Zeller T, Rocha-Singh KJ, et al.; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014;7(8):923-933.
6. Dippel EJ, Makam P, Kovach R, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis (EXCITE ISR). JACC Cardiovasc Interv. 2015;8(1 Pt A):92-101.
7. Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009;16(6):653-62.
8. Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012;19(4):480-488.
9. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360 trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014;26(8):355-360.
10. Mustapha J, Gray W, Martinsen BJ, et al. One-year results of the LIBERTY 360 study: Evaluation of acute and midterm clinical outcomes of peripheral endovascular device interventions. J Endovasc Ther. 2019;26(2):143-154.
11. Schwartz AW, Shah Y, Huang H, et al. Comparison of endovascular interventions for the treatment of superficial femoral artery disease: A Network Meta-analysis. J Soc Cardiovasc Angiogr Interv. 2025;4(1):102432.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Cardiology Magazine, ACC Publications, CM-Jun-2026, Atherectomy, Atherectomy, Coronary