Cath Lab Digest - November 2007 - (Page 54)

54 TCT NEWS NOVEMBER 2007 Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeich’s Genous™ Bio-engineered R Stent™ and Boston Scientific’s Taxus® Stent in Patients at High Risk of Restenosis T he preliminary results of the first-ever randomized study to compare OrbusNeich’s prohealing stent, the Genous Bio-engineered R stent, with Boston Scientific’s Taxus drug-eluting stent in high risk of restenosis patients show comparable efficacy at 30-day and six-month follow-up, reported Robbert de Winter, MD, PhD, principal investigator and director of the catheterization laboratory at the Academic Medical Center in Amsterdam, at this year’s Transcatheter Cardiovascular Therapeutics symposium, TCT 2007, in Washington, D.C. Genous is coated with an antibody to capture a patient’s endothelial progenitor cells, and, therefore 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 the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis. The stent was developed by OrbusNeich, a global medical device company. Specifically, six-month clinical follow-up data from the 193-patient, single-center, prospective, single-blind study called TRIAS HR Pilot indicate: • No statistically significant difference in the rate of major adverse cardiac events (MACE); • At six-month follow-up, the majority of patients who received a Genous stent were on single antiplatelet therapy, while the majority of patients who received a Taxus stent were still on dual antiplatelet therapy; • One acute stent thrombosis in the Genous arm, while there was one acute, one subacute and one late stent thrombosis in the Taxus arm; • More instances of non-target vessel revascularization (nonTVR) in the Taxus arm. “The much-needed alternative to drug-eluting stents may not be the next-generation drug-eluting stents,” said de Winter. “Genous is a very promising, innovative device with a wide range of applications for physicians and many benefits to patients. The results of our pilot study fully support our rationale for the large-scale TRIAS study that will compare Genous to both drug-eluting and bare metal stents.” For the TRIAS HR Pilot, high risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 20 mm) and/or chronic total occlusions. ■ PLC Medical Systems Introduced RenalGuard™ at TCT 2007 P LC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, introduced the RenalGuard System™ at TCT 2007, sponsored by the Cardiovascular Research Foundation, October 20-25, 2007, in Washington, DC. This is the first public showing for this technology in the United States. RenalGuard is an investigational system and therapy that targets patients with compromised renal function who may be at risk for contrastinduced nephropathy (CIN) when undergoing cardiovascular imaging procedures. RenalGuard Therapy is based on initial pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. The RenalGuard System is a fully-automated, real-time matched fluid replacement device intended for the at-risk segment of interventional cardiology and radiology patients undergoing these procedures. Earlier this year, the company announced the successful enrollment of the first patients in its FDAapproved pilot clinical trial designed to evaluate the safety of its RenalGuard System. Safety results were favorable, and there were no adverse renal events related to the device recorded. Studies indicate that approximately 15-20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35%. The company is currently conducting a pilot clinical safety study of its RenalGuard Therapy and RenalGuard System. RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is based on the theory that creating and maintaining a high urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The real-time measurement and matched fluid replacement design of the RenalGuard System is intended to ensure that a high urine flow is maintained before, during and after these procedures. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System with its matched fluid replacement capability is intended to minimize the risk of over- or under-hydration. ■ RESILIENT Trial Demonstrates Statistically Superior Results for Treating Peripheral Arterial Disease in the Leg E dwards Lifesciences Corporation announced the 12-month results from the RESILIENT Trial, presented as the “Blockbuster” Trial of the Day at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The landmark trial demonstrates statistically superior results using the LifeStent self-expanding stent versus balloon angioplasty alone in treating peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery. “The RESILIENT Trial is a randomized, multi-center study using the flexible LifeStent self-expanding stent in the understudied and challenging SFA region,” said Barry T. Katzen, MD, Founder and Medical Director of Baptist Cardiac and Vascular Institute, and co-principal investigator for The RESILIENT Trial. “The results of this trial show the statistical superiority of the LifeStent self-expanding stent versus balloon angioplasty alone as the need for follow-up intervention was 13% versus 54%, respectively, at 12 months.” The RESILIENT Trial further demonstrated the SFA patency rate, or percentage of vessels with unobstructed blood flow, was 80% for patients who received the LifeStent self-expanding stent versus 38% for patients with balloon angioplasty alone. “Results from The RESILIENT Trial are expected to establish the LifeStent self-expanding stent as an alternative for patients evaluating treatment options for SFA disease,” said co-principal investigator John R. Laird, MD, Medical Director of the Vascular Center at the University of California, Davis Medical Center. The LifeStent self-expanding nitinol stent specifically designed to withstand bending and twisting of the SFA. In 2004, Edwards initiated The RESILIENT Trial enrolling 246 patients at 25 sites, including 134 LifeStent self-expanding stent patients randomized against 72 balloon angioplasty patients. Edwards is currently in discussions with the U.S. Food and Drug Administration (FDA) for premarket approval of its LifeStent system with an SFA indication. ■

Table of Contents Feed for the Digital Edition of Cath Lab Digest - November 2007

Henry Ford Heart and Vascular Institute Treating Patients with Complex Vascular Disease with a Multi-Disciplinary Approach Improving Patient Compliance with Antiplatelet Medications Clinical Editor’s Corner Cath Lab Nurse/Tech Vascular Access and Closure Using the StarClose® Device The Clinical and Economic Impact of Measuring Fractional Flow Reserve FFR and Choosing an Optimal Revascularization Strategy Finally! The New Registered Cardiac Electrophysiology Specialist (RCES) Credential Use of a Mobile Lab to ‘Test the Waters’ at a Rural Hospital Remembering a Cardiac Cath Lab History ACVP• Membership Page What Do You Think? The Ten-Minute Interview with… Ernie Livingston, RN, BSN SICP* Chapter Updates Who’s in Charge? Working to Eliminate Bottlenecks: Florida Hospital’s Cardiac Cath Lab Achieves Greater Efficiency and Higher Satisfaction Preserving Left Ventricular Function during Percutaneous Coronary Intervention Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Making the Most of Your First Impression: Interviewing Tips and Techniques CEU Education Center Clinical & Industry News Meetings Calendar

Cath Lab Digest - November 2007

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