In November 2011, we reported the preliminary results of the REMEDEE clinical trial for the Combo Dual Therapy stent from OrbusNeich (Hoevelaken, Netherlands). The stent was developed to promote endovascular healing and cut the risk of restenosis compared to current bare-metal and drug-eluting stents. The randomized REMEDEE trial (Randomized Evaluation of an abluMinal sirolimus coatED bio- Engineered stEnt) found that the Combo Dual Therapy stent was non-inferior to the TAXUS Liberté paclitaxel-eluting stent based on in-stent late lumen loss at nine months.
More recently, at EuroPCR 2012, the company has announced the 12-month follow-up from the study. Data from that study indicate that the stent was associated with favorable clinical and safety outcomes over the TAXUS Liberté stent.
As an announcement explains:
In the 12-month follow-up data set, the clinically driven target lesion failure (TLF) rate was 8.9% for patients treated with the Combo Stent, compared to 10.2% for those treated with the TAXUS stent. Clinically driven TLF was defined as a composite of death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR). In addition, the rate of clinically driven TLR was 4.9% for patients treated with the Combo Stent, compared to 8.5% for those treated with the TAXUS stent. There was no stent thrombosis (ST) in either of the groups.
“The in-stent and in-segment late loss and binary restenosis rates were accordingly low for the Combo Stent and comparable to those of the TAXUS stent,” said Prof. [Michael Haude, MD, director of Medical Clinic I at the Lukaskrankenhaus (Neuss, Germany)]. “Additionally, we saw a uniform, homogeneous neointimal response with the Combo Stent, compared to the more heterogeneous and layered neointimal tissue appearance with the TAXUS stent.”
In addition, the company also reported that two subgroup analyses from the REMEDEE trial seem to confirm the Combo Dual Therapy stent’s ability to support vascular healing. In particular, the study found that neointimal volumes and thicknesses measured with optical coherence tomography were comparable at nine months after implantation for the Combo and TAXUS stents. A qualitative analysis within the stent demonstrated greater homogeneity in the appearance of neointimal tissue appearance in the Combo stent versus the TAXUS stent.
As separate announcement explains:
In detail, the Combo Stent placements had statistically significant more homogeneous tissue appearance compared to the TAXUS stent placements (79.2% versus 40%). Heterogeneous and layered tissue appearance was observed in 60% of the TAXUS stent placements and in 20.8% of the Combo Stent placements. Additionally, there were fewer microvessels and macrophage-like appearances inside the Combo Stent compared to the TAXUS stent: 8.3% versus 30% microvessels; 4.2% versus 10% macrophage-like appearances.
In the video below, Alexandre Abizaid, MD, from the Catheterization Laboratory, Institute Dante Pazzanese, São Paulo, Brazil, discusses preclinical data related to the Combo Dual Therapy stent.
Press releases: Early Coronary Artery Healing Advantage of OrbusNeich’s Combo Dual Therapy Stent(TM) Compared to the TAXUS® Stent Shown in Two Clinical Trial Subgroup Analyses…; OrbusNeich’s Combo Dual Therapy Stent(TM) Demonstrates Favorable Clinical and Safety Outcomes at 12-Month Follow-Up…
Flashbacks: OrbusNeich’s Genous Stent Technology Proven Safe in High Risk Patients; Sapphire II Coronary Dilation Catheter Gets Clearance in Europe; OrbusNeich’s Coronary Stent Shows Complete Neointimal Coverage in 26 Days