Cath Lab Digest - November 2007 - (Page 49)

NOVEMBER 2007 TCT NEWS 49 News from the Nineteenth Annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium Held October 20-25, 2007, in Washington, D.C. Drug-Eluting Balloons Show Promise as a Potential Alternative to Drug-Eluting Stents Used in the Treatment of Coronary Artery Disease D rug-eluting balloons could offer a viable alternative to drug-eluting stents (DES) in the treatment of coronary artery disease. Research results from two studies presented at the Late Breaking Trials sessions during the Cardiovascular Research Foundation’s (CRF) Nineteenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. support conducting further studies of the use of this potential therapeutic alternative. One of the studies marked the first direct comparison between DES and drug-eluting balloons. The SeQuent™ Please1 drug-eluting balloon catheter from B. Braun Melsungen AG in Germany delivers drugs directly to the lesion during angioplasty. A pilot study published last year in the New England Journal of Medicine first shed light on this potential treatment option.2 In the PEPCAD II study, Dr. Martin Unverdorben (Rotenburg, Germany) directly compared SeQuent™ Please to another manufacturer’s DES in 131 patients over six months. The team evaluated restenosis and the rate of major adverse cardiac events (MACE) such as heart attack, bypass, repeat stenosis, or death. Proving patients treated with the drug-eluting balloons experienced only 3.7 percent restenosis and 4.8 percent MACE, as compared to patients with DES, wherein restenosis was 20.8 percent with 22.0 percent MACE rate. Further supporting these results, a separate study by Unverdorben evaluated the use of drug-eluting balloons for the treatment of small vessel disease in 120 patients. PEPCAD I is the first study to investigate the use of drugeluting balloons in “native” lesions — those who have not already been treated by DES or bare metal stents. After six months, native lesions treated solely with SeQuent™ Please showed only a 5.5 percent binary restenosis rate and 6.1 percent MACE. These results compare quite favorably with previously published results using drug-eluting stents for the treatment of small vessel disease with 31.2 percent restenosis and 18.9 percent MACE. The development of SeQuent™ Please for the treatment of coronary artery disease is made possible through B. Braun Melsungen AG agreement with Charité Hospital in Berlin, Germany. The product features a unique matrix coating which is fully bioabsorbable and polymer-free, enhancing the drug transfer into vascular tissue. ■ 1. SeQuent Please is not approved or available for sale in the United States 2. Scheller et al. “Treatment of Coronary InStent Restenosis with a Paclitaxel-Coated Balloon Catheter.” New England Journal of Medicine November 16, 2006. Scheller presented the latest results of his ISR I and ISR II studies at TCT. Boston Scientific Promus™ And Taxus® Stents Demonstrate Safety And Efficacy Measures T he SPIRIT III clinical trial results continue to support the proven safety and efficacy of the Taxus® Express2™ paclitaxeleluting coronary stent system and add to the growing body of strong clinical evidence for the Xience™ V (Promus™) everolimus-eluting coronary stent system. An analysis of the data was presented by Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation in New York, and the Principal Investigator of the SPIRIT III Trial, during a late-breaking trial session at the Cardiovascular Research Foundation’s (CRF) 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. One-year results from the SPIRIT III trial included an updated analysis of 1,002 patients with coronary artery disease treated with either the Xience V (Promus) stent or the Taxus Express stent. Ischemia-driven target lesion revascularization (TLR) for 669 patients treated with the Xience V (Promus) stent changed from 2.6% to 3.3% between nine months and one year, while for the 333 patients treated with the Taxus stent, TLR changed from 5.0% to 56% during the same time period, still failing to reach statistical significance (p=0.09). Target vessel revascularization (TVR) at one year was also similar, with 6.1% for Xience V (Promus) and 7.5% for Taxus (p=0.41). The overall MACE (major adverse cardiac events) rate (defined as cardiac death, myocardial infarction (MI or ischemia-driven TLR) through one year was 5.8% for the Xience V (Promus) stent and 9.9% for the Taxus stent (p=0.01), reflecting an increased number of small (non-Q wave) MIs at the time of the procedure (2.5% vs. 3.8%). Subset analysis showed especially strong performance of the Taxus stent in diabetic patients with MACE rates remaining low at 4.7%, while MACE rates increased in the Xience V (Promus) stent to 8.8%. In long lesions (lesion length>13.2 mm), MACE was 7.7% for the Xience V (Promus) stent and 8.0% for the Taxus stent; in small vessels (RVD< / =2.775 mm), 6.1% for the Xience V (Promus) stent and 12.1% for the Taxus stent. Stent thrombosis rates through one year were also low for both the Taxus stent (0.6%, 0.6%) and the Xience V (Promus) stent (0.8%, 1.1%), using protocol and ARC definitions, respectively. The Promus stent has CE Mark approval and is distributed in most European countries and other international markets. The Promus stent is an investigational device in the U.S. and not yet approved for sale. It is currently under FDA review with an anticipated U.S. launch in 2008. The safety and efficacy of the Taxus Express2 stent system have not been established in patients with diabetes, long lesions and small vessels. SPIRIT is sponsored by Abbott. Subsets were not designed for statistical comparisons and demonstrated the above observational results. ■

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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