Covidien plc COV today announced 12-month results of the DEFINITIVE AR
study, the first randomized study designed to identify the clinical benefits
of plaque removal using directional atherectomy followed by drug coated
balloon. The results were presented by Professor Thomas Zeller of the
Universitaets-Herzzentrum, Bad Krozingen, Germany at the Vascular
Interventional Advances (VIVA) 2014 conference in Las Vegas, Nev.
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 Gunnar Tepe, Klinikum Rosenheim, Germany. “This data suggests when
the optimal amount of plaque is removed, that is <30 percent residual
stenosis, the patency rate is improved.”
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 Angiographic Core Lab assessment.
At 12 months, the percent stenosis in the randomized groups was 33.6 ± 17.7
for the DAART arm compared to 36.4 ± 17.6 for the DCB arm. These results were
observational as the study was not powered to detect differences between the
groups.
“This small but rigorous pilot study suggests an added benefit for DAART over
DCB in challenging lesions,” said Dr. Mark Turco, chief medical officer,
Vascular Therapies, Covidien. “Further investigation in larger, prospective,
statistically-powered randomized trials is warranted to confirm the positive
trends observed in DEFINITIVE AR and to evaluate a possible economic advantage
to a DAART strategy. Covidien continues to invest in the DEFINITIVE AR study,
and patients will be followed out to 24 months to assess the durability of the
results.”
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