China-based OrbusNeich has reported that its dual therapy stent met its primary endpoint and was found to be effective in controlling neointimal proliferation during a clinical study.
The study, Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt (REMEDEE), enrolled 183 patients with de novo native coronary artery stenoses.
The patients were randomised 2:1 to COMBO dual therapy stent or drug eluting stent (DES) implementation, including TAXUS Liberte paclitaxel-eluting stent.
The in-stent late lumen loss at nine months, a primary endpoint, was found to be 0.39 +/- 0.45mm for the COMBO Stent compared to 0.44 +/- 0.56mm for the control DES.
Lesion and procedural success, all-cause and cardiac mortality, MI, MACE and ST, as well as clinically (ischemia) driven TLR and clinically (ischemia) driven TVR at 30 days, nine months and one through five years were the secondary endpoints of the study.
No difference in mortality or occurrence of myocardial infraction (MI) was observed, and no ST was reported in either group, claims the study.
Professor Dr Michael Haude of the Medical Clinic I, Lukaskrankenhaus, Neuss, Germany, said: "Late and very late ST and a lack of durability of clinical effectiveness in the longer term remain issues with today’s monotherapy DES.
"With the COMBO Dual Therapy Stent, we have an innovative stent technology that may accelerate early healing and neointimal stent strut coverage to allow for a shorter duration of dual antiplatelet therapy (DAPT) without compromising efficacy in respect to in-stent late lumen loss, restenosis and the need for reintervention," Haude added.
"Additionally, intravascular ultrasound (IVUS)-virtual histology (VH) results revealed a bare metal stent (BMS)-like composition and morphology of the neointimal tissue for the COMBO Stent group versus DES, suggesting that the COMBO Stent may have the long-term safety profile of a BMS."