OrbusNeich has announced that data from the REMEDEE (Randomised evaluation of an abluminal sirolimus coated bio-engineered stent) study has been published online in JACC: Cardiovascular Interventions. The study demonstrated that the Combo dual therapy met the study’s primary endpoint and was found to be effective in controlling neo-intimal proliferation.
According to a company press release, the REMEDEE study also showed that the Combo stent was non-inferior to a drug eluting stent with respect to angiographic in-stent late lumen loss at nine months. Further, the stent was shown to be safe, with an overall low rate of clinical events, a low rate of binary restenosis and no stent thrombosis observed up to 12 months.
In the study, 183 patients with de novo native coronary artery stenoses were randomised 2:1 to Combo stent or drug-eluting stent implantation. The study’s primary endpoint was in-stent late lumen loss at nine months. Secondary endpoints included device, lesion and procedural success, all-cause and cardiac mortality, myocardial infarction, major adverse cardiovascular event (MACE), stent thrombosis, as well as clinically (ischaemia) driven target lesion revascularisation and clinically (ischemia) driven target vessel revascularisation at 30 days, nine months and one through five years.
At nine-month angiographic follow-up, the in-stent late lumen loss for the Combo stent was 0.39 +/- 0.45mm compared with 0.44 +/- 0.56mm for the control drug-eluting stent (the Taxus Liberté paclitaxel-eluting stent). This is well below the threshold of 0.50mm shown in the literature to be effective in preventing repeat revascularisation.
At 12 months, the MACE rate, defined as a composite of death, myocardial infarction, emergent coronary artery bypass grafting (CABG), or target lesion revascularisation by repeat percutaneous transluminal coronary angioplasty or CABG, was 8.9% for the Combo stent group and 10.2% for the drug-eluting stent group. The clinically driven target lesion revascularisation rate and the clinically driven target vessel revascularization were 4.9% and 6.5%, respectively, for the Combo stent group and 8.5% and 10.2%, respectively, for the drug-eluting stent group. No difference in mortality or occurrence of myocardial infarction was observed, and no stent thrombosis was reported in either group.
“Late and very late stent thrombosis and a lack of durability of clinical effectiveness in the longer term remain issues with today’s monotherapy drug-eluting stents,” said Michael Haude of the Medical Clinic I, Lukaskrankenhaus, Neuss, Germany, and first author of the publication. “With the Combo dual therapy stent, we have an innovative stent technology that may accelerate early healing and neo-intimal 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. Additionally, intravascular ultrasound (IVUS)-virtual histology (VH) results revealed a bare metal stent-like composition and morphology of the neo-intimal tissue for the Combo stent group versus drug-eluting, suggesting that the COMBO Stent may have the long-term safety profile of a bare metal stent.”
The Combo dual therapy stent combines an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days with a proven pro-healing antibody surface coating.