Directional Atherectomy Vessel Preparation Before DCB Angioplasty Evaluated in REALITY

November 6, 2020—The REALITY trial assessed the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) before drug-coated balloon (DCB) angioplasty in patients with symptomatic severely calcified femoropopliteal peripheral artery disease (PAD). 

The study found that plaque excision with this strategy is safe and effective with a low provisional stent rate.

Krishna Rocha-Singh, MD, presented the findings in the late-breaking clinical trial session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6–8, 2020.

The background of the study is that DCB angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal PAD but stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.

As summarized in the VIVA announcement, the REALITY study prospectively enrolled patients at 13 multinational centers with 8 to 36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and clinical events committee-adjudicated events.

The study enrolled 102 patients, with one lesion treated per patient. The mean lesion length was 17.9 ± 8.1 cm; 39% were chronic total occlusions (mean lesion length, 22.6 ± 8.6 cm); and 86% exhibited moderate to severe bilateral calcification. 

The REALITY study showed the following:

• Provisional stents were implanted in 9% (9/102) of patients
• The 12-month primary patency rate was 77% (66/86)
• The freedom from clinically driven target lesion revascularization rate was 93% (87/94)
• No device- or procedure-related deaths were reported
• One index-limb major amputation was reported.