Cath Lab Digest - December 2007 - (Page 42) 42 CLINICAL AND INDUSTRY NEWS DECEMBER 2007 COURAGE cont. Patients with stable coronary artery disease, especially those with a moderate to severe case, gained significant long-term health benefits from PCI when compared with a drugs-only approach, according to Dr. Leslee J. Shaw, the principal investigator and a professor of medicine at Emory University, who presented the latebreaking clinical trial at the AHA Scientific Sessions. Using a nuclear imaging technique called single photon emission computed tomography (SPECT), the study showed that patients with moderate to severe ischemia benefited most from PCI when compared with those who received only optimal medical therapy. In fact, when ischemia was reduced, the risk of death was also reduced. This finding confirms cardiologists’ general understanding of heart disease — that significant ischemia is not in a patient’s best long-term interests. The SPECT images, which enable physicians to assess the blood flow to the heart, showed that some patients had a very significant reduction in ischemia (more than 5 percent). Of patients who underwent PCI and took medications, 33 percent showed a reduction in ischemia of 5 percent or more, compared with only 19 percent of patients who took only medications. “This study also confirms the importance of identifying patients who are at most risk and who can therefore most benefit from PCI," Dr. Weiner said. Among the patients who had reduced ischemia, nearly 80 percent of both treatment groups were free of angina, which is characterized by chest pain that can be debilitating. PCI in addition to medications is clearly more effective than a medications-only approach in patients with high-risk ischemia (those with greater than 5 percent of their heart muscle compromised), according to the study. The COURAGE trial received widespread attention earlier this year when some concluded that PCI offered no reduction in the risk of death or heart attack in patients with stable coronary artery disease compared with using only drugs. The overall COURAGE trial looked at a narrow group of relatively healthy, stable patients who represented only about 30 percent of patients treated by interventional cardiologists. The nuclear sub-study demonstrates that even in these patients, the continued presence of ischemia increases the risks of death or heart attack. These risks can be reduced with revascularization. The COURAGE trial did not consider that many patients are not suitable for a medications-only approach because, although that approach may be desirable and recommended, such patients may not be able to tolerate side effects of the drugs or adhere to the strict regimen required due to multiple factors. The COURAGE trial also did not address significant quality-of-life factors for the stable angina population. In consultation with their physicians, many patients choose PCI because it offers almost immediate relief from pain and discomfort, and they are much more likely to be able to resume normal lifestyle activities sooner with far fewer symptoms than many patients who choose the medications-only route. ■ If you are interested in reading more about the presentation of this nuclear sub-study, please visit: http://scientificsessions.americanheart.org/portal/scientificsessions/ss/lb ctnr2a.2007 Abiomed Announces Results of Impella® 2.5 FDA PROTECT I Safety Trial for High-Risk PCI Cases A biomed, Inc. announced the results of its Impella® 2.5 PROTECT I safety trial for the first time at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium and main sessions. PROTECT I is the first prospective multi-center, FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures. The 20patient pilot study with the Impella 2.5 met all primary and secondary endpoints and showed very low adverse event rates in a very sick patient population. The results demonstrated no incidents of: aortic valve damage, aortic or mitral dysfunction, sepsis, stroke, thromboembolic events, vascular complications, insertion-site infection, device malfunction, device-related bleeding, limb ischemia, or clinical issues with hemolysis. "We begin the pivotal study with an expanded patient population, including high-risk PCI with triple-vessel disease for patients at up to 150 centers,” said Michael R. Minogue, Chairman, CEO and President of Abiomed. “Experience with the Impella 2.5 in the safety trial and in multiple studies in Europe under CE-Mark provides significant evidence of the clinical benefit to patients, and we continue to work with the FDA to bring this technology to the U.S." "In the PROTECT I pilot trial, Impella delivered supreme protection and support. It enabled success in procedures that would have been otherwise impossible," said Dr. J.P.S. Henriques, Cardiologist at the Academic Medical Center in Amsterdam. Dr. Laura Mauri of Brigham & Women’s Hospital also presented new data from the completed PROTECT I trial: "Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk PCI." An independent core lab analysis completed at Duke University determined no damage to the septum, heart chambers, or mitral/aortic valves. At a 30day follow-up, patients enrolled in the PROTECT I trial showed an improvement of their heart function demonstrated by an absolute increase of 7% in their left ventricular ejection fraction, equating to a 27% relative increase. "We have been impressed by the ease-of-use and high safety profile of the Impella 2.5 technology during the PROTECT I pilot trial,” said Dr. William O’Neill, National Principal Investigator for the pilot and pivotal studies of the Impella 2.5, and Professor and Executive Dean for Clinical Affairs, Division of Cardiology at the Leonard M. Miller School of Medicine at the University of Miami. Also announced for the first time at TCT was Abiomed’s new percutaneous right side catheter that can deliver greater than 4 liters of flow. This product will provide key support to the failing right ventricle and will be introduced first in Europe. Visit www.abiomed.co m for more information. ■ Computed Tomography Angiography Accurate in Detecting Coronary Artery Disease C omputed tomography (CT) angiography is as accurate as an invasive angiogram in detecting coronary artery disease, according to the findings of the first two prospective multi-center 64-slice scanner trials presented at the annual meeting of the Radiological Society of North America (RSNA). “These two trials with comparable results clearly set the stage for the widespread adoption of and reimbursement for coronary artery CT examinations,” said Gerald D. Dodd III, MD, chair of the Department of Radiology at the University of Texas Health Science Center in San Antonio. For the Coronary Artery Evaluation Using 64-Row Multidetector Computed Tomography Angiography (CORE-64) Trial, researchers at nine international centers studied 291 patients who were scheduled to undergo invasive coronary angiography for suspected or unknown coronary artery disease. The study found that 64-slice multidetector CT angiography was highly accurate in detecting blockages of greater than 50 percent, with a sensitivity of 85 percent and a specificity of 90 percent. The noninvasive exam was equal in accuracy to Continued on next page http://scientificsessions.americanheart.org/portal/scientificsessions/ss/lbctnr2a.2007 http://www.abiomed.co http://www.abiomed.co
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