Directional atherectomy followed by DCB effective to treat complex peripheral lesions
A strategy of directional atherectomy followed by drug-coated balloon treatment was beneficial in patients with long, calcified femoropopliteal lesions, according to 12-month results of the REALITY study.
Brian G. DeRubertis, MD, FACS, professor of surgery in the division of vascular and endovascular surgery at the David Geffen School of Medicine at UCLA, presented the results at the International Symposium on Endovascular Therapy.
DeRubertis and colleagues enrolled 102 patients (mean age, 70 years; 66% men) with femoropopliteal lesions 8 cm to 36 cm and bilateral vessel wall calcification in the single-arm study. All patients were treated with directional atherectomy (HawkOne and TurboHawk, Medtronic) followed by a DCB (IN.PACT Admiral, Medtronic).
Mean lesion length was 179.36 mm, and 67.6% of patients had a peripheral arterial calcium scoring system score of grade 4, indicating bilateral wall calcium of at least 5 cm, DeRubertis said.
“With a focus on uniquely long and complex lesions, the REALITY study was designed to explore the boundaries of endovascular therapy,” he said.
During the procedure, 3.1% of patients had perforations, 14.3% had grade C or worse dissections, 12.8% had distal embolization and 8.8% required provisional stenting, according to the researchers.
The primary effectiveness endpoint of 12-month primary patency was achieved in 76.7% of patients, whereas the primary safety endpoint of 12-month freedom from clinically driven target lesion revascularization was achieved in 92.6%, DeRubertis said.
“The REALITY study has demonstrated the safety and effectiveness of a strategy of excisional atherectomy followed by drug-coated balloon angioplasty for long, severely calcified lesions of femoropopliteal arteries,” he said. “Safety concerns include an embolization rate of 12.8%, which speaks to the complexity of these lesions.”
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DeRubertis B, et al. CLI and complex PAD. Presented at: the International Symposium on Endovascular Therapy (ISET); May 9-11, 2021; Miami Beach, Florida (hybrid meeting).