Twelve-Month e-HEALING Data Published for OrbusNeich's Genous Stent

February 22, 2011—OrbusNeich (Fort Lauderdale, FL) announced that 12-month follow-up data from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) demonstrated good clinical outcomes with low incidence of repeat revascularization and stent thrombosis for the company's Genous stent. Sigmund Silber, MD, et al published the registry findings in EuroIntervention (2011;6:819–825).

OrbusNeich stated that e-HEALING is a multicenter, worldwide prospective clinical registry conducted at 144 centers in 31 countries outside of the United States. The study included 4,939 patients with at least one lesion suitable for nonurgent percutaneous coronary intervention and Genous stent implantation. The mean age of the study population was 63 years, and 79% of patients were men.

In addition, 25% of patients in the study cohort had diabetes mellitus, and 37% had a previous myocardial infarction (MI). On average, 1.3 lesions per patient were treated—97.7% were de novo lesions and 10% were bifurcation lesions. For the lesions treated, 49% were type B2/C lesions. At 30-day follow-up, 83% of the patients were on dual-antiplatelet therapy (DAPT); 59% were on DAPT at 6 months, and 34% at 12 months. The 12-month primary outcome was target vessel failure (TVF). A secondary outcome was a composite of cardiac death, MI, or target lesion revascularization (TLR). Other secondary outcomes included stent thrombosis.

According to the company, TVF, defined as target vessel-related cardiac death or MI and target vessel revascularization (TVR), was 8.4% at 12 months. The composite of death, MI, or TLR occurred in 7.9% of the patients. TLR and stent thrombosis were 5.7% and 1.1%, respectively.

“The good clinical outcomes for the Genous stent in real-world use, especially the low incidence of stent thrombosis, demonstrate that the pro-healing approach of the Genous stent is effective for a range of challenging patient groups," commented Professor Silber, who served as coprincipal investigator. “As shown previously in several subset analyses of the e-HEALING registry, the Genous stent produces exceptional outcomes in diabetic and elderly patients."

Also in EuroIntervention, Paolo Scacciatella, MD, et al reported on a single-center registry studying the Genous stent with 2-year outcomes in 61 patients with a high risk for restenosis who cannot receive drug-eluting stents for various reasons, including those who need surgery within 2 months and those with a high bleeding risk or who are allergic to aspirin (2011;6:826–830). Victoria Martin-Yuste, MD, et al presented findings from another single-center registry of 78 patients with high comorbidities who required chronic anticoagulation due to atrial fibrillation, mechanical valve prosthesis, cardiomyopathy, or previous emboli (2011;6:831-837). Emanuele Barbato, MD, and William Wijns, MD, discussed the Genous stent in an editorial on autologous cell therapy for enhanced endovascular repair after coronary stent implantation (2011;6:794–797).