News | November 14, 2014

Covidien Announces 12-Month DEFINITIVE AR Results at VIVA 2014

- Peripheral artery disease trial suggests long-term benefit for PAD treated with atherectomy followed by drug-coated balloon

Nov. 14, 2014 — Covidien releases 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 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

“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 Mark Turco, M.D., 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.”

For more information:

Related Content

News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
Overlay Init