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

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 was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. RESULTS: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. CONCLUSIONS: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent.

IMPORTANCE: Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG). RESULTS: About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days. Treated lesion lengths were 7.8 cm ± 4.3 cm in the trial with chronic total occlusions comprising 24.6% (65/264) of subjects. Freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months was 89%, at 24 and 36 months it was 84% and 82% respectively. The difference in the 12 month CD-TLR was 7% at 36 months. The difference of clinically driven-TLR at 36 months in those subjects who received their stents deployed nominally in length, compressed or elongated (between -10% and +10% nominal length) had an impact on the CD-TLR. At 2 and 3 years, freedom from CD-TLR in minimal compression was 86.7%, and was 90.0% for moderate compression. In those stents deployed with minimal, moderate, or severe elongation (10-20%, 20-40%, or >40%, respectively) freedom from CD-TLR of 84.1%, 87.4%, and 77.0% respectively at 12 months. At 2 and 3 years, freedom from CD-TLR for moderate elongation was 81.8% and 78.2%, and for severe elongation was 63.4% and 42.3%, respectively. Fractures were distinctly uncommon with this stent with a single facture event in the 36 month follow-up period. DISCUSSION: The interwoven nitinol design stent is a stent that achieves an excellent primary patency but further maintains the durability of the stent through 36 months. Optimal stent deployment remains critical to the performance of this stent device and requires optimal vessel preparation. © 2017 Wiley Periodicals, Inc.