DEFINITIVE AR 30-Day Results Presented on Directional Atherectomy Plus DCB

October 10, 2013—The DEFINITIVE AR study's 30-day results were presented by Professor Thomas Zeller, MD, at a late-breaking trial session during the VIVA 2013: Vascular Interventional Advances conference, being held October 8–11 in Las Vegas, Nevada.

DEFINITIVE AR is a prospective, multicenter, randomized pilot study designed to evaluate directional atherectomy using either the SilverHawk or TurboHawk plaque excision systems (Covidien, Mansfield, MA) followed by a paclitaxel-coated balloon (Bayer HealthCare's [Whippany, NJ] peripheral paclitaxel-coated angioplasty catheter with Paccocath technology), collectively referred to as DAART (directional atherectomy and antirestenotic therapy), compared to treatment with the paclitaxel drug-coated balloon alone (DCB arm).

The study includes lesions 7 to 15 cm long in femoropopliteal arteries in patients with claudication (Rutherford clinical category [RCC] of 2–4). Forty-eight patients were randomized to the DAART arm and 54 patients to the DCB arm. Baseline lesion characteristics did not differ between arms. The study also included a third registry arm evaluating the DAART procedure in severely calcified lesions, for which results are forthcoming, noted the investigators.

Technical success (defined as ≤ 30% residual stenosis following the protocol-defined treatment at the target lesion as determined by the Angiographic Core Laboratory) was significantly higher in the DAART arm (90% vs 64%; P = .004). Likewise, residual diameter stenosis following the protocol-defined treatments was significantly lower in the DAART arm (18% vs 28%; P = .0002). Adjunctive therapy in the DAART arm consisted of three (6.3%) post-dilations with PTA. Adjunctive therapy in the DCB arm included 18 (33.3%) postdilations with PTA and two (3.7%) stents.

At the 30-day follow-up assessment, 88.6% (39/44) and 90% (45/50) of patients had an improvement of at least one RCC level in the DAART arm and DCB arm, respectively. Compared to baseline, 88% of patients in the DAART arm and 89% of patients in the DCB arm showed an improvement in ABI at the 30-day follow-up visit.

Professor Zeller concluded that acute results of the DAART treatment show a high technical success rate and acceptable periprocedural complications. He noted that long-term data to determine the durability of this treatment combination and the incremental benefit of directional atherectomy are necessary and forthcoming.