Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study

Abstract

Background: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.Objectives: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD.Methods: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 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

Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial

“…The recent REALITY single-arm study (N ¼ 102 patients) reported on the safety and effectiveness of directional atherectomy followed by DCB therapy to treat long, severely calcified femoropopliteal PAD. 33 Although the primary patency rate at 1 year was 76.7% in this challenging lesion cohort, the rates of angiographic complications remained high (major dissection: 14.3%; perforation: 3.1%; distal embolization despite the use of embolic protection: 12.8%; bailout stenting: 8.8%). Cross-trial comparisons to the Disrupt PAD III are difficult, and randomized trials are needed to assess the comparative outcomes between IVL and atherectomy in the treatment of calcified PAD.…”

“…31 Although not evaluated in Disrupt PAD III, the use of atherectomy to treat calcified PAD has been reported in small randomized and single-arm studies. 15,16,[32][33][34][35] Atheroablative technologies can be effective in debulking vascular calcium and improving luminal area, but procedural complications remain a concern. The recent REALITY single-arm study (N ¼ 102 patients) reported on the safety and effectiveness of directional atherectomy followed by DCB therapy to treat long, severely calcified femoropopliteal PAD.…”

“…Meaningful cross-trial direct comparisons between Disrupt PAD III and trials involving other calcium-modifying technologies are not possible given the differences in trial parameters. 15,32,33 Randomized trials comparing IVL and atherectomy (rotational, orbital, or directional) are required to define the relative safety and effectiveness of these devices. Second, these results may not be generalizable to patients with chronic limb threatening ischemia due to calcified, stenotic infrapopliteal lesions owing to the prespecified trial eligibility criteria.…”

Successfully treating the common femoral artery “no go zone” with directional atherectomy plus antirestenotic therapy (DAART)

“…4 In the multicenter VIVA REALITY study, DAART was evaluated in 102 patients with complex, long FP stenosis or occlusions (17.9 ± 8.1 cm) with moderate to heavy calcification. 5 Procedural-related adverse events such as flow-limiting dissection or perforation occurred in 14 patients; all resolved with EVT during the index procedure with provisional stenting in 8.8%. Twelve-month PP was 76.7% and freedom from CD-TLR was 92.6% with one major amputation.…”

“…Similarly, in the Directional Atherectomy Followed by a Paclitaxel‐Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency (DEFINITIVE AR) pilot study ( n = 121), DAART was seen to be both safe and effective in complex femoral‐popliteal (FP) disease, although the study was not sufficiently powered to make a randomized comparison between DAART and DCB alone for long‐term outcomes and 20% of patients were deemed unsuitable for DCB alone 4 . In the multicenter VIVA REALITY study, DAART was evaluated in 102 patients with complex, long FP stenosis or occlusions (17.9 ± 8.1 cm) with moderate to heavy calcification 5 . Procedural‐related adverse events such as flow‐limiting dissection or perforation occurred in 14 patients; all resolved with EVT during the index procedure with provisional stenting in 8.8%.…”