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