Clinical and Industry News Cont.

Abbott Announces New Trial in Stroke Prevention: ACT I ACT I will study the potential benefits of minimally invasive carotid stenting in patients who normally would have surgery Abbott will begin enrolling patients during the first quarter of 2005 in its asymptomatic carotid trial, ACT I. This multi-center, randomized trial will compare carotid artery stenting to carotid artery surgery in asymptomatic patients who normally would be referred for surgery. Abbott recently received conditional approval for this study from the U.S. Food and Drug Administration (FDA). Ken Rosenfield, MD, director of Cardiac Invasive Services at Massachusetts General Hospital and co-principal investigator of ACT I, said, ACT I is designed to assess the benefits of carotid stenting for those patients at risk of stroke for whom surgery and/or medication remain the only options. Abbott submitted its Xact® Carotid Stent System and Emboshield® Embolic Protection System for FDA approval in September 2004, and the device is currently under review. ACT I, which stands for Carotid Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Patients with Significant Extracranial Carotid Occlusive Disease Trial, will compare CAS to CEA in asymptomatic patients who are at standard risk for surgery. This randomized trial is designed to establish the non-inferiority of CAS to CEA in this patient population. The CAS arm of the trial will use Abbott’s Xact Carotid Stent System and Emboshield Embolic Protection System, which were designed together specifically for carotid stenting procedures. All patients enrolled in the trial will receive appropriate medications and lifestyle modification counseling during the study. The trial will involve up to 50 hospitals in the United States and approximately 1,500 patients, with primary endpoint data submitted after one year of patient follow-up. The trial’s primary endpoints are as follows: (1) 30-day major adverse event (MAE) rates combining stroke, death and myocardial infarction; and, (2) ipsilateral strokes between 31 and 365 days. The trial’s secondary endpoints include target lesion revascularization rate, device/procedural success rates, cumulative composite morbidity (nerve damage, wound complications, general anesthetic complications, etc.), and long-term ipsilateral stroke rates through five years of followup. In addition to comparing clinical impacts, ACT I will assess the relative economic and quality of life factors associated with CAS and CEA. The trial will quantify not only device and facility costs, but also the total costs to the health care system of each treatment option. Such information will help to support informed decision-making in procedural reimbursement and treatment selection. This information is especially important, given that stroke is the leading cause of inpatient Medicare expenses for long-term care. In examining patient lifestyles after CAS and CEA procedures, ACT I will evaluate the speed and quality of patients’ recoveries, as well as how quickly and easily they return to their regular routines. CEA and CAS are radically different in the way they impact patients’ lifestyles and ability to function, said Dr. Rosenfield. ACT I will provide key decision makers a clearer picture of how these procedures affect not only our patients’ health, but also their broader lives. In the United States, the Emboshield Embolic Protection System and the Xact Carotid Stent System are investigational devices not approved for sale. Both the Emboshield and the Xact have CE Mark approval for distribution in European Union and European Free Trade Association markets. Emboshield was developed to minimize the risk of distal embolization. Recently, Emboshield was proven to be the most effective filter at preventing embolization in an in-vitro model among the carotid embolic protection devices studied by independent scientists. Emboshield moves freely on a proprietary wire, Barewire, and physicians can select from a range of Barewires for use in different anatomies and procedures. Designed specifically for carotid arteries, the Xact self-expanding nitinol stent offers a closed cell configuration that is designed to avoid filter snagging during retrieval; a high coverage ratio intended to reduce the release of stroke-generating plaque; and straight and tapered stent constructions intended to enhance conformance to the carotid anatomy. Freestyle Technology helps ensure exact placement of the stent at the targeted site. Radi Medical Systems Announces 510K Clearance of RadiAnalyzerXpress for Fractional Flow Reserve (FFR) Measurement Radi Medical Systems AB (Radi) announced the 510(k) clearance of their newest product, RadiAnalyzer®Xpress. Together with the recently released PressureWire®5 Sensor, it makes up a system for measurement of Fractional Flow Reserve (FFR). The new RadiAnalyzerXpress system is a lightweight, flat panel instrument. It uses an on-screen guide with step-by-step instructions for instrument setup. PressureWire5 Sensor has mechanical manoeuvrability, pushability and a tip design with improved shape retention for long and complex procedures. Radi’s physiology platform is the only system on the market that provides measurement of pressure (FFR), flow (CFR) and intravascular temperature using a single PressureWire5 Sensor and one instrument. All data is easily transferred to a PC for research and storage. The RadiAnalyzerXpress and PressureWire5 Sensor are available for sale in the U.S. Reviparin Effective in Reducing Risk of Death After Heart Attack The drug reviparin (a low molecular weight heparin anticoagulant), when administered to patients with a heart attack, is effective in reducing the risk of death and the risk of a subsequent heart attack, according to a recent study. Salim Yusuf, DPhil, FRCPC, of Hamilton General Hospital and McMaster University, Ontario, Hamilton, Canada, and colleagues evaluated the effects of reviparin on the composite outcome of death, heart attack, and stroke at 7 and 30 days. The randomized, double-blind, placebo-controlled trial (Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation [CREATE]), included 15,570 patients with ST-segment elevation or new left bundle-branch block. The patients presented within 12 hours of symptom onset at 341 hospitals in India and China from July 2001 through July 2004. Patients received reviparin (n = 7,780) or placebo (n = 7,790) subcutaneously twice daily for seven days. The researchers found that the primary composite outcome was significantly reduced from 11.0 percent of patients in the placebo group to 9.6 percent in the reviparin group, a 13 percent lowered risk. These benefits persisted at 30 days (13.6 percent vs. 11.8 percent) patients, a 13 percent lowered risk; with significant reductions in the 30-day death rate (11.3 percent vs. 9.8 percent), 13 percent lower rate; and additional MI (2.6 percent vs. 2.0 percent), a 23 percent lower rate; and no significant differences in strokes (0.8 percent vs. 1.0 percent). Reviparin treatment was significantly better when it was initiated very early after symptom onset at 7 days (less than 2 hours: 30% reduced risk; 30 of 1,000 events prevented; between 2 to 4 hours: 19% reduced risk; 21 of 1,000 events prevented; between 4 to 8 hours: 15% reduced risk; 16 of 1,000 events prevented; and greater than 8 hours: 6% increased risk. There was an increase in life-threatening bleeding at 7 days with reviparin and placebo (17 [0.2%] vs. 7 [0.1%], respectively); but the absolute excess was small (1 more event per 1,000) compared with the reductions in the primary outcome (18 fewer per 1,000) or mortality (15 fewer per 1,000). Reviparin is less expensive than other antithrombotic agents, and can be given subcutaneously. Its use is straightforward and can be used in both developed and developing countries. Therefore, the benefits of reviparin represents a moderate but important globally applicable advance in the management of patients with acute MI, the researchers conclude. Therapy with Glucose-Insulin-Potassium Infusion Not Beneficial for Treating MI A widely applicable, inexpensive therapy was found to have no effect on death rates when treating patients who had an acute ST-segment elevation myocardial infarction (STEMI). Shamir R. Mehta, MD, MSc, of McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada, and colleagues evaluated the effects of high-dose glucose-insulin-potassium (GIK) infusion on patients with acute STEMI. GIK is a low-cost therapy that has been speculated to improve mortality in heart attack patients. The study (a merger of CREATE and Estudios Cardiologicas Latin America Study Group, ECLA [CREATE-ECLA]) was conducted in 470 centers worldwide among 20,201 patients with STEMI who presented within 12 hours of symptom onset. The average age of patients was 58.6 years, and evidence-based therapies were commonly used. Patients were randomly assigned to receive GIK intravenous infusion for 24 hours plus usual care (n = 10,091) or to receive usual care alone (controls; n = 10,110). The researchers found: The CREATE-ECLA trial demonstrated that high-dose GIK solution given for 24 hours in patients presenting with acute STEMI has a neutral effect on mortality, cardiac arrest, and cardiogenic shock. The goal of our study was to reliably assess the effects of high-dose GIK in preventing mortality and major cardiovascular events in patients with STEMI. Given that there were more than 1,900 deaths in the study, it was well powered to detect even a moderate effect on mortality, the researchers note. The very high adherence to the protocol and the excellent 30-day follow-up (99.85%) provide confidence in the validity of our findings and suggest that it is very unlikely that the current regimen of high-dose GIK is of any material benefit in reducing mortality in patients with STEMI. Philips Teams with Northcentral Technical College Northcentral Technical College (NTC) and Philips announced a collaboration to facilitate training courses and technology demonstrations for students, technologists and regional healthcare facilities that will expand NTC’s current health program. Education and training will be provided at a new 126,000 square foot facility, located on the NTC campus in Wausau, WI. NTC chose to team with Philips to offer customized training courses utilizing imaging technologies such Philips Picture Archiving and Communication System (PACS), X-ray, Ultrasound, Magnetic Resonance (MR) and Computed Tomography (CT). As the first technical college to join with Philips, we will be able to provide physicians, students, and healthcare providers in Northcentral Wisconsin with hands-on experience operating advanced medical systems, said Robert Ernst, president, Northcentral Technical College. Practitioners and developing medical professionals will benefit from learning and interacting with this equipment, which will help them deliver more thorough and insightful care to patients once they get to a clinical setting. Training and education will include regional campuses. Experts from NTC and Philips educational staff will work together to develop programs to educate technologists on diagnostic imaging systems. As part of the 5-year agreement with NTC, Philips will install a number of products that are used for medical imaging, radiology and radiography. Additionally, the facility will also install two workstations one for MR and one for CT enabling students to analyze and edit images. Edwards Can Start Heart Valve Trial Edwards Lifesciences Inc. has received conditional approval from the U.S. FDA to start a trial testing its minimally invasive procedure to replace the aortic valve. The new heart valve being tested by the company is delivered via a percutaneous approach and is still far from the market. The FDA’s conditions are straightforward and the company is ready to enroll its first patient, Edwards said. Irvine, California-based Edwards said it would conduct an initial feasibility study of 20 patients at high risk for conventional heart valve surgery. That study would look at patient outcomes at 30 days. A second feasibility trial, which would enroll an additional 40 patients, would be conducted upon completion of the first trial. Pending those results, Edwards plans to do a larger, multi-center pivotal trial of its Cribier-Edwards Percutaneous Aortic Heart Valve.

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