REALITY study “sets new benchmark” for assessment of claudicants with severe femoropopliteal disease


Krishna Rocha-Singh (Springfield, USA) speaks to Vascular News about his presentation at VIVA20 (Vascular Interventional Advances; 6–7 November 2020; virtual) on the REALITY study, which examined the safety and efficacy of directional atherectomy combined with drug-coated balloon to treat patients with long, calcified femoropopliteal artery lesions. There is now a better understanding of the use of the words “severe calcification” by the application of a novel calcium assessment tool called the peripheral artery calcification (PAC) index, he notes.

Rocha-Singh discusses the 12-month results of REALITY which indicate that in these patients the use of directional atherectomy prior to the application of an antimitotic is “both safe and effective.”

Freedom from clinically-driven target lesion revascularisation was approximately 93% and primary patency was upwards of 78%, says Rocha-Singh, noting that these two metrics in a “complex” group of patients with significant femoropopliteal disease “gives us some cause to investigate further this type of treatment strategy”.

Rocha-Singh concludes by explaining that although this dual use strategy has been “boosted” by these results, they cannot be broadly applied to all directional atherectomy devices and drug-coated balloons, as a “class effect” cannot be assumed.


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