News | November 15, 2011

Polymer-Free DES Results in Lower In-Stent Late Loss Than DES With Polymers

November 15, 2011 — Researchers have found polymer-free amphilimus-eluting stents in de novo coronary artery lesions showed a significantly lower in-stent late loss at six months compared to paclitaxel-eluting stents with permanent polymers.

Results of the NEXT trial were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. NEXT is a prospective, randomized trial comparing a polymer-free amphilimus-eluting stent to a paclitaxel-eluting stent.

The risk/benefit balance of coronary drug-eluting stents (DES) is still suboptimal and the safety of coating polymers, which hold and release the drug over time, remains uncertain. Researchers sought to demonstrate the non-inferiority of polymer-free amphilimus-eluting stents versus permanent-polymer paclitaxel-eluting stents in de novo native coronary artery lesions. The primary endpoint was six-month angiographic in-stent late loss within a non-inferiority scope. Late loss is the difference between the diameter of a stented segment post-procedure compared with the follow-up angiogram.

A total of 323 patients were enrolled, with 162 randomized to amphilimus-eluting stents and 161 to paclitaxel-eluting stents. In-stent late loss was significantly lower with amphilimus-eluting stents (0.14±0.36 mm vs. 0.34±0.40 mm, P<0.0001 for non-inferiority, P<0.0001 for superiority). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization or stent thrombosis) up to 12 months did not differ significantly.

“These results are encouraging evidence that support the use of polymer-free stents, but further studies are warranted to prove that this potent polymer-free stent can improve the risk-benefit balance of coronary drug-eluting stents,” said Didier Carrié, M.D., Ph.D., the principal investigator of the trial. Carrié is professor of medicine, cardiology at the University of Paul Sabatier and the head of hemodynamics and angioplasty section at Rangueil Hospital in Toulouse, France.

The NEXT trial is funded by CID. Carrié reported no financial relationship with the company.

For more information: www.crf.org

       

Related Content

Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | 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 | Clinical Study | 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 | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init