|Covidien Announces 12-Month DEFINITIVE AR Results at VIVA 2014|
Results suggest long-term benefits for peripheral artery disease patients treated with directional atherectomy followed by a drug-coated balloon
DEFINITIVE AR results demonstrated higher technical success and lower incidence of vessel injuries known as flow-limiting dissections. Additionally, the study suggests the combination of directional atherectomy and anti-restenosis therapy with drug coated balloons (known as DAART) improves patency in long and severely calcified lesions. Longer lesions have lower patency across all current treatments, and presence of calcification may prohibit drug uptake and lead to less durability and loss of patency. Patency is the ability for the treated artery to remain open. (Click here for a summary of research findings.)
“DEFINITIVE AR was designed as a hypothesis-generating study to detect trends in treatment differences between patients who were treated with DAART and patients who were treated with drug-coated balloons (DCB) alone. While the use of DCBs to treat peripheral artery disease has demonstrated reduced restenosis, there have been limited clinical studies evaluating the effectiveness of DCBs in complex disease,” said Professor Zeller. “The results suggest DAART may address an unmet clinical need in difficult to treat long or severely calcified lesions.”
Duplex Ultrasound primary patency rates for the long (≥10 cm) lesion subset at 12 months were 96.8 percent in patients treated with DAART compared to 85.9 percent in patients treated with DCB alone. Primary patency rates at 12 months in severely calcified lesions, per core lab assessment, were 70.4 percent in DAART patients compared to 62.5 percent in DCB alone patients.
“Lumen gain, or the amount of plaque removed from the artery with
directional atherectomy prior to DCB treatment, may also be a critical
factor in contributing to the long-term clinical success of DAART
therapy,” said Professor
Results showed 94.1 percent primary angiographic patency for DAART when more plaque was removed with directional atherectomy (less than 30 percent residual stenosis was achieved) compared to 68.8 percent patency when less plaque was removed (more than 30 percent residual stenosis) prior to treatment with the DCB. Directional atherectomy is unique as it allows for the largest amount of luminal gain while maintaining vessel integrity.
The primary endpoint of the study was defined as the percent stenosis
(narrowing of the vessel), at one year per
“This small but rigorous pilot study suggests an added benefit for DAART
over DCB in challenging lesions,” said Dr.
About the DEFINITIVE AR Study
DEFINITIVE AR, a prospective, multi-center, randomized, pilot study,
utilized the Covidien SilverHawk™ and TurboHawk ™ directional
atherectomy systems and the
The primary outcome was target lesion percent stenosis at one year following initial treatment. Key secondary outcomes included primary patency by Duplex Ultrasound at 12 months following the procedure, primary patency by angiographic assessment at 12 months following the procedure, and assessment of major adverse events at 12 months following the procedure.
Clinical follow-up occurred at pre-discharge, 30 days, six months and one year post-procedure. Two-year follow-up is underway. This is the first randomized study involving a drug-coated balloon that included angiographic follow-up at one year to assess patency.