Cath Lab Digest - April 2008 - (Page 51)

51 12-Month Data From ENDEAVOR IV Show Strong Clinical Efficacy Across All Patient Groups D ata showing strong clinical efficacy for Medtronic’s Endeavor® drug-eluting stent were presented at the American College of Cardiology meeting. ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of Target Vessel Failure (TVF) at nine months and a secondary endpoint of major adverse cardiac events (MACE) at 30 days. The principal investigator is Dr. Martin B. Leon of Columbia University Medical Center and the Cardiovascular Research Foundation in New York. The Endeavor drug-eluting stent is made of a cobalt alloy and is built on the same platform as Medtronic’s Driver bare metal stent, which features a modular architecture designed to enhance deliverability. In addition to the cytostatic drug zotarolimus, Endeavor is coated with phosphorylcholine (PC) technology, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane. The combination of these components is designed to contribute to rapid, complete and functional healing of the endothelium. Entitled “One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus Taxus in de novo Native Coronary Lesions” (2803-8), the presentation featured an analysis of 477 diabetic patients from the ENDEAVOR IV clinical study. ENDEAVOR IV is an ongoing head-to-head comparison of the Endeavor and Taxus stents in 1,548 patients. The two tables shown are a summary of the principal findings for the diabetic subset. “Performance of drug-eluting stents in diabetic patients is scrutinized by doctors because diabetes complicates so many aspects of the angioplasty procedure. Achieving good efficacy is more difficult, and safety concerns are significantly increased.” said Dr. Jeffrey Popma, Director of Invasive Cardiovascular Services, Caritas Cardiovascular Center for the Caritas Saint Elizabeth’s Medical Center in Boston, and director of the core lab that performed the angiographic analysis for the entire ENDEAVOR clinical program, including ENDEAVOR IV. Launched in the United States in February and now available in more than 120 countries worldwide, the Endeavor stent is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of ≥ 2.5 mm to ≤ 3.5 mm. Impact of angiography on TLR reinforced. Also presented at the ACC scientific session were the findings of two other substudies from the ENDEAVOR IV clinical trial. One analysis – “The Impact of Mandatory Angiographic Follow-up on the One-Year Clinical and Angiographic Results From Endeavor IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System vs. Taxus in De Novo Native Coronary Lesions” ENDEAVOR IV results at 12-month follow-up (2900-103) — illustrated for diabetic patients the artificial impact of routine angiography on Endeavor Taxus revascularization rates. (n = 241) (n = 236) The first 328 enrolled Overall mortality 0.0% 0.9% ENDEAVOR-IV patients Cardiac death 0.0% 0.0% were selected to undergo Myocardial infarction 0.9% 0.9% angiography immediately Stent thrombosis 0.9% 0.4% post-procedure and again Target lesion revascularization (TLR) 6.9% 6.8% after eight months. These Target vessel revascularization (TVR) 8.6% 9.4% results were compared to Target vessel failure (TVF) 8.6% 10.8% the subsequent 1,200 patients in whom angiography was not performed. ENDEAVOR IV side-branch occlusion results In patients receiving angiographic follow-up, Endeavor Taxus p value the TLR rate at 12 months (log rank) was 8.5 percent for Side-branch 2.2% 4.8% p=0.032 Endeavor and 3.0 percent occlusion post-stenting for Taxus but with no angiographic follow-up, the TLR rates were 3.6 percent for Endeavor and 3.3 sion post-stenting. The analysis was conducted as percent for Taxus. These findings support the ARC rec- doctors seek to explain the significantly increased ommendations that PCI clinical studies assess lesion rate of periprocedural MI with Taxus when comcharacteristics with angiography only after the follow pared to Endeavor observed in the ENDEAVOR IV up required to assess the primary clinical endpoint. clinical trial. Side-branch occlusion with Endeavor. A second The ENDEAVOR IV clinical trial was not sub-analysis – “The Fate of Side-Branches Among prospectively designed to evaluate side-branch Patients Treated With Zotarolimus-Eluting and occlusions, so further study is warranted. ■ Paclitaxel-Eluting Stents: An ENDEAVOR-IV The safety and effectiveness of the Endeavor stent have not Substudy” (2901-19) – looked at side-branch occlu- been established in diabetic patients. Data would first require both FDA review and approval. Range of Healthcare Offerings Help Philips Customers Reduce Critical Time to Treatment for Heart Attack Patients Philips’ Cardiology Solutions Help Providers Reduce Time to Treatment for Phoenix-area Heart Attack Patients by Nearly 45 Minutes E very minute counts for many heart attack patients. In the case of patients suffering from ST-segment elevation myocardial infarction (STEMI), the current ACC-recommended “door-toballoon” (D2B) protocol is less than 90 minutes. Philips’ technologies can help hospitals reduce D2B time by clearing a path from discovery to treatment. The Philips HeartStart MRx monitor/defibrillator enables paramedics to wirelessly transmit vital 12-lead electrocardiogram (ECG) data on the heart’s condition while en route to the hospital. Once this data is received, caregivers move into action, preparing the cath lab before the patient arrives. Philips informatics solutions throughout the D2B care cycle deliver instant access to and seamless sharing of clinical information throughout the hospital. Inside the emergency department and cath lab, Philips cardiovascular imaging equipment helps clinicians pinpoint issues in the heart and allows for confidently planned and executed interventional procedures. Some of these solutions are helping the community of Glendale, Arizona save valuable time for critical STEMI patients. Outfitted with a HeartStart MRx in every fire engine, the Glendale Fire Department utilizes the innovative pre-hospital triaging technology when a patient displays symptoms consistent with STEMI. Coninued on next page

Table of Contents Feed for the Digital Edition of Cath Lab Digest - April 2008

Cath Lab Digest - April 2008 Kaiser San Rafael Medical Center Orbital Atherectomy: A New Treatment for Complex Peripheral Arterial Disease Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Contents Clinical Editor’s Corner CEU Education Center The Missing Link in STEMI Interventions — Thrombus Aspiration during Primary Percutaneous Coronary Intervention Predicting Stent Thrombosis Using A Clinical Risk Score Use of a New Guidewire: The Tigerwire Should I Stay or Should I Go? Weighing Options for New Opportunities Navigating Tortuous Coronary Sinus Anatomy Using a Bipolar Lead The National Society of Radiology Practitioner Assistants (NSRPA) Holds 9th Annual Educational Conference For Medical Imaging Physician Extenders and Mid-Level Healthcare Providers Cath Lab & Beyond: A Meeting Update The Ten-Minute Interview with… Dale Hansen RT, CVT Sometimes, You Just Know Twin Circumflex Arteries: A Rare Coronary Artery Anomaly What Do You Think? Meetings Calendar News from the American College of Cardiology (ACC) Scientific Session and the Society of Cardiovascular Angiography & Interventions (SCAI) Annual Scientific Sessions in Partnership with the ACC i2 Summit Clinical & Industry News Cath Laughs Classifieds Advertisers Index

Cath Lab Digest - April 2008

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