Directional Versus Orbital Atherectomy Compared in Treatment of Femoropopliteal Artery Lesions

October 31, 2023—Revascularization and restenosis rates at 24 months were presented from a prospective, head-to-head, randomized study evaluating the impact of orbital versus directional atherectomy on atherosclerotic plaque in patients with peripheral artery disease (PAD).

In the study, 60 patients with symptomatic PAD were randomized 1:1 to the two atherectomy modalities. Lesions were then treated with a drug-coated balloon (DCB). Intravascular ultrasound (IVUS) was performed before and after atherectomy, as well as after DCB treatment.

The primary endpoints were change in plaque and luminal volume via IVUS and change in angiographic stenosis. The secondary endpoints were device success rate and rate of bailout stenting, as well as restenosis and revascularization rates at up to 3-year follow-up.

Anvar Babaev, MD, presented the 24-month findings during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

According to the VIVA press release, directional atherectomy demonstrated a greater plaque volume reduction and luminal gain, with significantly fewer stents needed post-DCB compared to orbital atherectomy at the index procedure.

At 24 months, the investigators observed numerically higher restenosis and revascularization rates in the orbital atherectomy group verse the directional atherectomy group but this did not reach statistical significance. The difference was more pronounced in patients who were not stented during the index procedure.

Comparing the directional arm to the orbital atherectomy arm, the restenosis rates were 13% versus 33.3% (P = .15) and the revascularization rates were 13% versus 27.8% (P = .27).

Dr. Babaev advised that larger studies and longer follow-up are needed to further evaluate these observed findings, noted the VIVA press release.