News | January 09, 2008

R Stent May Have Lower MACE Rate than Drug-Eluting Stents

January 10, 2008 - Patients who received OrbusNeich’s Genous Bio-engineered R Stent had significantly fewer major cardiac adverse events (MACE) than patients who received FDA-cleared drug-eluting stents in a study conducted at Federico II University of Naples in Naples, Italy.

The results of the study were presented recently at the XXVIII National Congress of the Italian Society of Invasive cardiology by Federico Piscione, M.D., the study’s principal investigator and a professor with the university's Division of cardiology, Department of Clinical Medicine and Cardiovascular Sciences. The Genous is coated with an antibody to capture a patient’s endothelial progenitor cells to accelerate the natural healing process.

At clinical follow-up of 10 months, the cumulative MACE rate for the Genous group (GRS) was 4 percent versus 22 percent for the combined TAXUS and CYPHER group (DES). For the MACE components, the cumulative rate of target vessel revascularization (TVR) was 1 percent for GRS versus 11.8 percent for DES, the cumulative rate of myocardial infarction (MI) was 1 percent for GRS versus 7.8 percent for DES, and the cumulative mortality rate was 2 percent for GRS versus 7.8 percent for DES. In addition, the cumulative rate for stent thrombosis was 2 percent for GRS versus 5.8 percent for DES.

"Our findings suggest that the deployment of Genous stents in a consecutive series of high-risk patients is safe and effective, with a significantly lower in-hospital incidence of MACE and a better long-term clinical outcome when compared to drug-eluting stents," said Piscione. "Genous attracts circulating endothelial progenitor cells to rapidly build a layer of healthy tissue and promote long-term natural healing."

The study involved 195 consecutive high-risk patients who underwent percutaneous coronary intervention (PCI) with either GRS or DES implantation at the university’s cath lab. 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 nine months. Complete clinical follow-up was obtained for 100 percent of the patient population. High risk was defined as advanced age, high rate of conventional risk factors for CAD, multivessel disease, multivessel stenting and depressed left ventricular ejection fraction.

For more information: www.unina.it

Related Content

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS) bioabsorbable stent.

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS).

Feature | Stents Drug Eluting| January 17, 2018 | Dave Fornell
There was no shortage of interest in bioresorbable stent technologies at the many sessions offered on this topic or b
Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System
Technology | Stents Drug Eluting| December 13, 2017
Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) approval of...
The Xience Sierra stent.
Technology | Stents Drug Eluting| November 09, 2017
November 9, 2017 — Abbott received European CE mark for Xience Sierra, the newest generation of the company's Xience
Synergy Stent With Shorter DAPT Superior to Bare-Metal Stent in Elderly Patients
News | Stents Drug Eluting| November 06, 2017
November 6, 2017 — Elderly patients undergoing...
Biotronik Orsiro DES Shows Low Five-Year Event Rates
News | Stents Drug Eluting| November 03, 2017
November 3, 2017 — Biotronik's Orsiro...
Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

Image courtesy of OrbusNeich

News | Stents Drug Eluting| November 01, 2017
OrbusNeich reported results from the REDUCE trial in the Late-Breaking Clinical Trial session at the 29th annual...
News | Stents Drug Eluting| October 25, 2017
Elixir Medical Corp. announced it will unveil a new metallic drug-eluting stent (DES) platform at this year’s...
Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
News | Stents Drug Eluting| September 01, 2017
September 1, 2017 — Biotronik recently announced data from the BIOFLOW-V randomized trial comparing Orsiro and Xience
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Overlay Init