Cath Lab Digest - November 2007 - (Page 52)

52 TCT NEWS NOVEMBER 2007 Abiomed Announces Results of Impella® 2.5 FDA PROTECT I Safety Trial for High-Risk PCI Cases A biomed, Inc. announced the results of its Impella® 2.5 PROTECT I safety trial for the first time at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium and main sessions. PROTECT I is the first prospective multi-center, FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures. The 20-patient pilot study with the Impella 2.5 met all primary and secondary endpoints and showed very low adverse event rates in a very sick patient population. The results demonstrated no incidents of: aortic valve damage, aortic or mitral dysfunction, sepsis, stroke, thromboembolic events, vascular complications, insertion-site infection, device malfunction, device-related bleeding, limb ischemia, or clinical issues with hemolysis. “We begin the pivotal study with an expanded patient population, including high-risk PCI with triple-vessel disease for patients at up to 150 centers,” said Michael R. Minogue, Chairman, CEO and President of Abiomed. “Experience with the Impella 2.5 in the safety trial and in multiple studies in Europe under CE-Mark provides significant evidence of the clinical benefit to patients, and we continue to work with the FDA to bring this technology to the U.S.” “In the PROTECT I pilot trial, Impella delivered supreme protection and support. It enabled success in procedures that would have been otherwise impossible,” said Dr. J.P.S. Henriques, cardiologist at the Academic Medical Center in Amsterdam. Dr. Laura Mauri of Brigham & Women’s Hospital also presented new data from the completed PROTECT I trial, “Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk PCI.” An independent core lab analysis completed at Duke University determined no damage to the septum, heart chambers, or mitral/aortic valves. At a 30-day followup, patients enrolled in the PROTECT I trial showed an improvement of their heart function demonstrated by an absolute increase of 7% in their left ventricular ejection fraction, equating to a 27% relative increase. “We have been impressed by the ease-of-use and high safety profile of the Impella 2.5 technology during the PROTECT I pilot trial,” said Dr. William O’Neill, National Principal Investigator for the pilot and pivotal studies of the Impella 2.5, and Professor and Executive Dean for Clinical Affairs, Division of Cardiology at the Leonard M. Miller School of Medicine at the University of Miami. Also announced for the first time at TCT was Abiomed’s new percutaneous right side catheter that can deliver greater than 4 liters of flow. This product will provide key support to the failing right ventricle and will be introduced first in Europe. More information will be provided in the future. ■ Two Studies of Carotid Artery Stenting Demonstrate Results Comparable to AHA Guidelines for Patients Treated with Surgery T wo carotid stenting trials examining patient outcomes demonstrated results that are comparable to guidelines established by the American Heart Association (AHA) for patients treated with carotid artery surgery. The results of these studies were presented at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium by William A. Gray, MD, FACC, associate professor of clinical medicine at Columbia University College of Physicians and Surgeons and director of endovascular services at the Center for Interventional Vascular Therapy at New YorkPresbyterian Hospital/Columbia University Medical Center in New York. Dr. Gray also is the director of endovascular services at the Cardiovascular Research Foundation. An interim analysis of patients treated with carotid stents in Abbott’s CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) and EXACT (Emboshield and Xact Post Approval Carotid Stent Trial) postmarketing trials, which enrolled 4,111 patients in over 150 sites, demonstrated 30-day patient outcome results consistent with longstanding AHA guidelines for patients with a severe carotid stenosis but who do not have symptoms. These guidelines recommend that rates of complications for carotid artery surgery to prevent stroke be less than 3 percent for patients without symptoms of stroke (asymptomatic) and 6 percent for patients with symptoms of stroke (symptomatic). “In these two well-conducted carotid artery stenting studies, carotid stenting has achieved outcomes comparable guidelines established for patients who undergo carotid surgery, and has done so in a population of patients who are at high risk for experiencing adverse events from surgery,” said Dr. Gray. “This is a significant report because this is the first time that these guidelines have been achieved by any revascularization therapy in a large, multi-center examination of such patients, and although the guidelines were established for surgery (before stenting was practiced), there are no comparable surgical results in this group of patients.” In 1998, the American Heart Association published its 30-day outcome guidelines in Circulation for patients treated with carotid artery surgery. These guidelines were based on the observed stroke and death rates in patients with carotid artery disease who had undergone carotid endarterectomy. The guidelines were based on studies of surgery in patients who did not have excessive risks for anesthesia, etc., but left unanswered what the best therapy is for patients for whom surgery was risky. These two studies are the first demonstration of a therapy providing stroke prevention (carotid artery stenting) in these patients. The CAPTURE 2 study included 1,987 patients and utilized Abbott's Acculink™ Carotid Stent System and Accunet™ Embolic Protection System. The EXACT study included 2,124 patients and utilized Abbott's Xact ® Rapid Exchange Carotid Stent System and Emboshield BareWire™ Rapid Exchange Embolic Protection System. The key objective of both trials was to determine whether carotid stenting could be performed safely in the real-world clinical setting by physicians with varying levels of experience. The primary endpoints were death, stroke and MI at 30 days. The demographics of patients in both trials were similar. The 30-day composite endpoints of stroke and death for patients in the CAPTURE 2 and EXACT studies were: • 3.1 percent and 3.0 percent combined stroke and death in CAPTURE 2 and EXACT patients without symptoms under age 80 • 6.0 percent and 7.3 percent combined stroke and death in CAPTURE 2 and EXACT patients with symptoms under age 80 • 3.8 percent and 4.0 percent stroke and death within 30 days of treatment for the combined patient populations Patient enrollment for the CAPTURE 2 trial is ongoing. The EXACT trial is closed and 30-day follow up has been completed. ■

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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