Cath Lab Digest - November 2007 - (Page 51)

51 CELLO Trial cont. 2007 following the conclusion of the trial, which enrolled 65 patients at 17 hospitals in the United States. Highlights of the data presented include: • Achievement of significant tissue removal, which exceeded the targeted primary endpoint, measured by angiographic and intravascular ultrasound (IVUS) core labs; • Demonstrated durability of procedure through freedom from target lesion revascularization in 86% of the patients through six months following the initial procedure; • No major adverse cardiac events reported through six months following the procedure, which adds to the existing body of clinical evidence supporting the safety of laser ablation; • Significant improvement in all clinical outcomes measured six months following the procedure, including Rutherford category, anklebrachial Index, and walking impairment. “The six-month data from the CELLO trial demonstrates the ability of laser ablation facilitated by the Turbo-Booster to safely restore blood flow in the superficial femoral artery and significantly improve clinical outcomes in patients with peripheral arterial disease up to six months following the procedure,” said Dr. Rajesh Dave, national principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital. The Turbo-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. Combined with Spectranetics’ Turbo elite™ laser catheters, it allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries. John G. Schulte, Spectranetics’ president and CEO, noted, “Since receiving FDA clearance in July, several hundred procedures have been performed.” ■ Bivalirudin Significantly Improved Net Outcomes in STEMI Patients In Major Global Trial, Bivalirudin Reduced Net Adverse Clinical Events, Major Bleeding and Cardiac-Related Death Compared to Heparin Plus a Glycoprotein IIb/IIIa Inhibitor I n a landmark global trial of heart attack patients undergoing angioplasty, the anti-clotting agent Angiomax® (bivalirudin) resulted in superior clinical outcomes and fewer cardiac deaths compared to a more complex treatment regimen. These findings from the HORIZONS AMI [*] trial were presented at a late-breaking session of the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium sponsored by the Cardiovascular Research Foundation. Angiomax is available in Europe as Angiox®. The HORIZONS AMI trial compared bivalirudin to heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) in more than 3,600 patients presenting with a heart attack. Among bivalirudin patients, 7.2% received provisional use of a GPI. Results at 30 days were as follows: • Bivalirudin significantly reduced the incidence of net adverse clinical events, a composite of major adverse cardiac events or major bleeding, by 24% (9.2% vs. 12.1%, p = 0.006). • Bivalirudin significantly reduced the incidence of major bleeding by 40% (4.9% vs. 8.3%, p < 0.0001). • Bivalirudin demonstrated comparable rates of major adverse cardiac events (5.4% vs. 5.5%, p = 1.0). • Bivalirudin significantly reduced the incidence of cardiac-related mortality by 38% (1.8% vs. 2.9%, p= 0.035). “These data show that the benefits of bivalirudin therapy extend to patients with heart attacks. We now have compelling evidence supporting the use of bivalirudin instead of heparin and GPI in virtually all patients undergoing angioplasty,” said Gregg W. Stone, MD, professor of medicine, Columbia University Medical Center and chairman of the Cardiovascular Research Foundation, which conducted the trial. “This landmark trial will help shape best practices and guidelines for drug therapy during angioplasty in patients with heart attacks.” Bivalirudin has previously been shown to result in less bleeding and similar rates of composite ischemia compared to heparin plus GPI in patients undergoing angioplasty for stable angina,1 unstable angina and non-ST-elevation myocardial infarction (NSTEMI).2 HORIZONS AMI demonstrates that these advantages also apply to angioplasty patients with the most severe form of heart attack, ST-elevation myocardial infarction, or STEMI. Reduced bleeding in angioplasty patients has been shown in other studies to be associated with greater long-term survival.3-4 “This study is an important step forward in our efforts to improve outcomes for heart attack patients,” said Harvey D. White, MD, Director of Coronary Care and Cardiovascular Research at Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. He noted the death rate associated with heart attacks 20 years ago was as high as 13 percent.5 This rate has fallen with the introduction of thrombolytics and stents. “Based on data presented today, using bivalirudin instead of combination therapy may further reduce the incidence of cardiac-related death,” Dr. White added. HORIZONS AMI, co-funded by a grant from The Medicines Company, is the largest study to focus on the appropriate use of anticoagulation medications in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI). The trial is a prospective, single-blind, randomized, multi-center study in more than 3,600 patients presenting with a heart attack to hospitals in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either bivalirudin with provisional use of GPI or heparin plus GPI. Patients enrolled in the HORIZONS AMI trial also were assigned randomly to receive either Taxus® drug-eluting stents or a bare-metal stent. The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days. ■ References 1. Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction 2. Lincoff AM, Kleiman NS, Kereiakes DJ, et al. REPLACE-2 Investigators. Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE2 randomized trial. JAMA 2004 Aug 11;292(6):696-703. 3. Stone GW, McLaurin BT, Cox DA, et al. ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med 2006 Nov 23;355(21):2203-2216. 4. Stone GW, Bertrand ME, Lincoff AM, et al. A prospective, randomized trial of bivalirudin in acute coronary syndromes: one year results from the ACUITY trial. Presented at: 56th Annual Scientific Session of the American College of Cardiology, New Orleans, March 24-27, 2007. 5. Yusuf S, Mehta SR, Chrolavicius S, et al. Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006 Apr 6;354(14):1464-76. Epub 2006 Mar 14.

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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