Cre8, BioFreedom Polymer-Free DES Show Promise
San Francisco, CA—As investigators search for ways to reduce polymer-associated complications, early data on two polymer-free DES show positive results, according to findings presented at TCT 2013.
The Cre8 stent
Specific benefits for patients with diabetes first became apparent in the 6-month results of the international, multicenter NEXT randomized trial, which compared the Cre8 stent (Carbostent & Implantable Devices) with a paclitaxel-eluting stent (PES; Taxus Liberté, Boston Scientific). Rates of in-stent late lumen loss were similar in patients with diabetes and in the overall population (see Figure), Antonio Colombo, MD, of Columbus Hospital/San Raffaele Hospital, Milan, Italy, said.
“Unfortunately, the number [of patients with diabetes] was not very high, so this is just hypothesis-generating, but it is quite provocative to see the same late loss,” Colombo said. “This gives us more standing to evaluate the possible thrombosis-friendly characteristic of the device.”
The BioFreedom stent
A first-in-man trial showed promising results for the BioFreedom stent (Biosensors) compared with a PES (Taxus Liberté). Outcomes at 48 months for MACE were similar between BioFreedom and the PES (13.6% vs. 13.3%). “This was essentially related to the [target lesion revascularization],” Philip M. Urban, MD, of La Tour Hospital, Geneva, Switzerland, said.
MACE outcomes for BioFreedom low dose were 23.4%. There were no reports of stent thrombosis in any group.
In a cohort of 107 patients who received 12-month angiographic follow-up, patients receiving BioFreedom with a standard drug dose had a median late lumen loss of 0.17 mm (95% CI 0.09-0.39), compared with 0.35 mm (95% CI 0.22-0.57) for patients receiving PES (P=.001 for non-inferiority).
Additional trials to come
There are several trials underway that will further explore the efficacy of polymer-free stents. Long-range goals for Cre8 include a decrease in dual antiplatelet therapy duration and an increase in DES efficacy in high-risk patients.
The next major study for BioFreedom is LEADERS FREE, which will enroll 2,500 PCI patients at high risk for bleeding, Urban said. Half will receive BioFreedom and half will receive a BMS (Gazelle, Biosensors). The primary safety endpoint will be a composite of cardiac death, MI and definite/probable stent thrombosis at 1 year. The primary efficacy endpoint will be clinically driven TLR at 1 year.
LEADERS FREE is the first trial of a polymer-free DES to focus on those with high bleeding risk, the first trial of a polymer-free DES with clinical endpoints, and will have the shortest-ever DAPT course for an active stent, Urban concluded.
Colombo reports receiving consultant fees from Carbostent & Implantable Devices; and being a minor shareholder of Cappella Inc. and Direct Flow Inc.
Urban reports receiving grant/research support from Abbott Vascular, Biosensors and Medtronic CardioVascular; and consultant fees/honoraria from Biosensors and Edwards Lifesciences.