Cath Lab Digest - November 2007 - (Page 50)

50 TCT NEWS NOVEMBER 2007 Positive One-Year Results from Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary Stent One-Year Data on First 30 Patients Enrolled in Ongoing Study Presented A bbott announced continued positive results from ABSORB, a clinical trial evaluating the safety and performance of a fully bioabsorbable drugeluting stent platform for the treatment of coronary artery disease. One-year results from the first 30 patients in the trial demonstrated no stent thrombosis and a low major adverse cardiac event (MACE) rate at 12 months (1 patient, 3.4 percent, n=29), with no additional MACE, including no re-treatment of a diseased lesion (ischemia-driven target lesion revascularization) since six months for patients who received a bioabsorbable stent. The overall MACE rate in the ABSORB trial at six months was 3.3 percent, as previously announced in March 2007. The results were presented at the Cardiovascular Research Foundation’s 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. “We continue to see consistent positive data from consecutive patient follow-up in the ABSORB trial,” said Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. “Abbott’s bioabsorbable coronary artery stent technology has maintained initial safety and effectiveness results in patients out to one year.” Abbott’s bioabsorbable everolimuseluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As reported in March 2007, late loss, a measure of reduction in lumen (vessel) diameter after stenting, was 0.44 mm for ABSORB at six months. The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. Key endpoints of the study include assessments of safety — MACE (defined as any event that resulted in re-treatment of a diseased artery, heart attack or cardiac death) and stent thrombosis rates — at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drugeluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug-eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years. For images of Abbott’s bioabsorbable stent and other information, please visit www.abbottvascular.com ■ Therox™ AMIHOT II Pivotal Trial Meets Endpoints Data Shows Significant Infarct Size Reduction in Acute Myocardial Infarction Patients T herOx, Inc., a privately held medical device company, announced it has successfully met its endpoints for its pivotal trial, AMIHOT II (Acute Myocardial Infarction with Hyperoxemic Oxygen Therapy), which studied superoxygenation therapy for acute myocardial infarction (AMI) patients. The results were presented during a late-breaking session at the 19th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, in Washington D.C. The data will be submitted shortly to the FDA as part of the company’s Premarket Approval (PMA) application. AMIHOT II showed superiority of the adjunctive administration of superoxygenation therapy over the current AMI standard of care alone — available drug regimens coupled with urgent percutaneous coronary intervention (PCI) — by demonstrating a significant reduction in infarct size for patients treated within six hours from symptom onset for anterior AMI. The prospective, multicenter, randomized trial studied more than 300 STEMI (ST-segment elevation myocardial infarction) patients for a new therapy called superoxygenation therapy, in a new treatment category called myocardial salvage intervention (MSI). Superoxygenation therapy, an adjunctive therapy performed immediately after PCI, has shown promise to reduce infarct size and thus preserve heart muscle during an acute heart attack. Myocardial salvage intervention is a new treatment category for AMI patients that salvages the jeopardized myocardium and reduces infarct size. “AMIHOT II demonstrated a significant reduction in infarct size with superoxygenation therapy compared to the current standard of care for anterior AMI patients treated by angioplasty within six hours of symptom onset,” said the study’s principal investigator, Dr. Gregg W. Stone from Columbia University Medical Center and the Cardiovascular Research Foundation in New York. “The positive results shown in AMIHOT II significantly expand AMI treatment options for interventional cardiologists and their patients affected by large heart attacks.” For more information, visit www.therox.com. ■ Caution: Investigational device. Limited by Federal (or United States) law to investigational use. Spectranetics Announces Clinical Data From CELLO Trial S pectranetics Corporation announced the presentation of results from its CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) clinical trial, at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The study was a prospective, non-randomized trial designed to provide clinical data on the reduction of arterial blockage in above-the-knee arteries following use of the Spectranetics Turbo-Booster™ product for the treatment of peripheral artery disease (PAD). Turbo-Booster received clearance from the Food and Drug Administration (FDA) in July Continued on next page http://www.abbottvascular.com http://www.therox.com

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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