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Implant successfully repairs dissections caused by angioplasty
LAS VEGAS — An endovascular implant used to repair dissections caused by plain or drug-coated balloons during angioplasty in peripheral procedures was associated with positive outcomes, according to data presented at VIVA 18.
The implant (Tack Endovascular System, Intact Vascular), was evaluated in TOBA II, “the first and only pivotal trial to enroll 100% dissected vessels,” William A. Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of the Lankenau Heart Institute in Wynnewood, Pennsylvania, said during a presentation.
“The current tools we have to treat dissection have some limitations,” he said. “The Tack Endovascular System addresses specific stent drawbacks with a novel device. A single device deploys multiple tacks, increasing vessel diameter. Compared with traditional stents, which when compressed, exhibit increasing outward radial force, the Tack has a very flat outward radial force curve, such that with increasing pressure, no increase in outward radial force is seen. This results in much less inflammation and also, in preclinical testing, much less neointimal hyperplasia.”
The device also self-sizes between 2.5 mm and 6 mm and has an anchoring system to minimize migration, he said.
For TOBA II, the researchers enrolled 213 patients (mean age, 68 years; 71% men) who had post-angioplasty dissection from a plain balloon or a drug-coated balloon (Lutonix, Bard).
The primary safety endpoint was 30-day freedom from new-onset major adverse events, defined as amputation above the ankle, clinical events committee-adjudicated clinically directed target lesion revascularization and all-cause mortality. The primary efficacy endpoint was primary patency at 12 months, defined as freedom from clinical events committee-adjudicated clinically directed TLR and freedom from binary restenosis.
Gray said the primary safety (79.3%; P < .0001) and primary efficacy (P = .0006 for intention-to-treat population; P = .0005 for per-protocol population) endpoints were met.
Freedom from clinically directed TLR at 12 months was observed in 86.5% of patients.
Though 69.4% of the cohort had a dissection of grade C or worse, 92.1% of dissections were completely resolved after the implant, Gray said, noting that only one patient required bailout stenting, there were no cases of tack fracture and there was one case of tack migration.
Among the cohort, 63% improved at least two Rutherford classes (P < .0001), and mean ankle-brachial index, Walking Impairment Questionnaire score and Physical Activity Questionnaire score all improved (P < .0001 for all), he said.
“The trial successfully demonstrated that the Tack repairs dissections after both POBA and DCB with minimal metal, no radial force, a safe and durable design and preservation of future treatment options,” Gray said. “The high patency rate and high rate of freedom from clinically driven TLR position the Tack to be a clinically relevant and important treatment option for dissection repair after balloon angioplasty.” – by Erik Swain
Reference:
Gray WA, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.
Disclosure: Gray reports he received honoraria from Boston Scientific and Medtronic, consulted for Abbott Vascular, Boston Scientific, Cook Medical, Intact Vascular, Medtronic and W.L. Gore and Associates, holds equity in BioCardia, Contego Medical and Silk Road Medical and received research funding from Boston Scientific, Intact Vascular and W.L. Gore and Associates.