A vessel preparation treatment strategy of directional atherectomy prior to drug-coated balloon angioplasty with Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) in long, calcified femoropoliteal lesions is effective out to one year, with an acceptable safety profile. This was the conclusion of Krishna-Rocha Singh (Prairie Heart Institute, Springfield, USA) in a late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020; 6–8 November, virtual), presenting new data from the REALITY study.
REALITY (Directional atherectomy plus drug-coated balloon to treat long, calcifIed femoropopliteal artery lesions) prospectively enrolled subjects at 13 multinational centres with 8–36cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with directional atherectomy 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 (CEC)-adjudicated events.
The study enrolled 102 subjects; one lesion was treated per subject. The mean lesion length was 17.9±8.1cm; 39% were chronic total occlusions (mean lesion length 22.6±8.6cm); and, 86% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 9% (9/102) of patients. Twelve-month primary patency rate was 77% (66/86) and freedom from clinically-driven target lesion revascularisation (CD-TLR) rate was 93% (87/94). No device- or procedure-related deaths were reported; one index-limb major amputation was reported.
Rocha-Singh concluded that plaque excision with directional atherectomy in patients with symptomatic severely calcified femoropopliteal arterial disease prior to IN.PACT Admiral DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.
Commenting on the importance of these results, Rocha-Singh told Vascular News: “VIVA REALITY I think sets a new benchmark for the assessment of claudicants with severe femoropopliteal disease characterised by excessive lesion lengths […] and significant bilateral calcification, and suggests that the use of directional atherocath is very efficient in removing atheroma and that that is reflected in the primary safety and effectiveness endpoints at 12 months with a very compelling from CD-TLR and primary patency.”
However, he cautioned against generalisation: “Until another company steps forward, with the type of data that was presented with REALITY, with three core labs, specifically an angiographic core lab, a duplex Doppler core lab, a histology core lab, with all clinical advance adjudicated by a CEC, we cannot and must not equate the results of REALITY with any other combinations of atherectomy devices and drug-eluting balloons.”