July 7, 2008 - OrbusNeich today said data recently presented at the 17th Annual Meeting of the Japanese Society of Interventional Cardiology demonstrate that the Genous Bio-engineered R stent has better outcomes when compared to drug-eluting stents.
Presented by Federico Piscione, M.D., the study’s principal investigator and a professor with the Federico II University of Naples’s Division of Cardiology, Department of Clinical Medicine and Cardiovascular Sciences, the data was generated following a study involving 257 consecutive high-risk patients who underwent percutaneous coronary intervention with either the Genous stent or a TAXUS and CYPHER stent at the university’s catheterization lab.
At 13 months clinical follow-up, the cumulative MACE rate for the Genous (GRS) group was 17.2 percent versus 26.4 percent for the combined TAXUS and CYPHER group (DES) - a 35 percent reduction. For the MACE components, the rate of myocardial infarction (MI) was 4.5 percent for GRS versus 6.8 percent for DES, the re-percutaneous coronary intervention (Re-PCI) was 7.5 percent for GRS and 13.5 percent for DES, and the cardiac death rate was 4.5 percent for GRS versus 7.4 percent for DES. In addition, the rate for stent thrombosis was zero percent for GRS versus 5.8 percent for DES.
“Our results suggest that the Genous Bio-engineered R stent is safe and effective in high-risk patients,” said Dr. Piscione. “The results show a better long-term clinical outcome when compared with DES.”
After PCI, patients who received GRS were prescribed dual-antiplatelet therapy for one month, and patients who received DES were prescribed the same therapy for 12 months. A complete clinical follow-up was obtained in 100 percent of GRS patients vs. 96 percent of DES patients.
Additionally, 22 consecutive patients requiring “life saving,” undeferrable major noncardiac surgery (NCS) or endovascular aortic repair (EVAR), underwent coronary angiography for clinical or instrumental signs of ischemia before NCS or EVAR and were treated with the Genous stent. Antiplatelet therapy was stopped five days prior to scheduled surgery in all patients, with an average antiplatelet therapy duration of 12.5 days. After NCS, thienopyridine administration was not restarted and 100 mg per day of ASA was the only cardiac antiplatelet therapy at discharge. MACE, including in-hospital cardiac death, MI, stent thrombosis, surgical bleeding complications, need for revascularization and 30 day after surgery clinical follow-up, were evaluated.
The results of the study indicated an optimal acute procedural result in all patients. The 22 patients included in the study underwent uneventful NCS 10 to 22 days after coronary stent deployment. MACE rates were zero percent at in-hospital follow-up and at one month follow-up.
“The Genous stent may offer a new, important and feasible therapeutic strategy for patients needing to undergo life-saving or undeferrable major noncardiac surgery early after coronary stent deployment,” Dr. Piscione said.
Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient’s EPCs to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.
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