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Boston Scientific Announces Start of Enrollment in Groundbreaking Clinical Trial Comparing Drug-Eluting Stents to Cardiac Surgery |
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SYNTAX Trial Will Study Most Complex Patient Subsets
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NATICK, Mass., April 12 -- Boston Scientific Corporation (NYSE: BSX - News) today announced that enrollment has begun in its clinical trial known as SYNTAX, which will compare the performance of drug- eluting stents with cardiac surgery in the most complex patient subsets: those with coronary artery disease in all three coronary arteries, in the left main coronary artery, or both. This randomized, controlled clinical trial is designed to compare 12-month outcomes of percutaneous coronary intervention (PCI) using the Company's TAXUS® Express2™ paclitaxel-eluting coronary stent system with coronary artery bypass graft (CABG) treatment. SYNTAX is a multi-center, prospective trial that will involve over 4,200 patients at up to 90 sites in Europe and the United States. In recent years, the outcomes and risks of both CABG and less-invasive PCI treatments have been substantially improved through new treatment strategies, patient monitoring and technologies such as drug-eluting stents. Previous studies comparing CABG and PCI using bare-metal or drug-eluting stents have been limited to highly selected patient populations. For the most severe form of coronary artery disease involving all three coronary arteries, the left main artery, or both, the optimal treatment strategy remains undetermined. The SYNTAX trial uses an innovative enrollment methodology that enrolls consecutive patients without significant exclusion criteria. Based on an initial assessment, the treating cardiothoracic surgeon and interventional cardiologist will jointly decide whether a patient meets the eligibility requirements for both treatment approaches (CABG and PCI). Patients who are eligible for both treatment options will be enrolled in the randomized arm comparing CABG to PCI, which will include approximately 1,500 patients. Patients determined to be eligible for only one treatment option will be enrolled in one of two "nested" registries tracking either CABG or PCI, which will include approximately 2,750 patients combined. Results from the randomized arm will help compare CABG to PCI in treating patients eligible for both treatment options. The primary endpoint is the 12-month major adverse cardiac and cerebral event (MACCE) rate, which includes death, myocardial infarction, repeat revascularization and stroke. The nested registries will define profiles of patients eligible for only one of the treatment options. The trial's Principal Investigators are Professor Friedrich Mohr, M.D., Program Director of the Heart Center/Cardiothoracic Surgery, University of Leipzig, Germany and Professor Patrick Serruys, M.D., Ph.D., Chief of Interventional Cardiology, Thoraxcenter-Erasmus University Rotterdam, The Netherlands. Marie-Claude Morice, M.D., Head of Cardiology, Institut Hospitalier Jacques Cartier in Massy, France enrolled the first patient in the SYNTAX randomized cohort on April 5, along with Arnaud Farge, M.D., the surgical co- principal investigator at the Institute. Other sites are scheduled to enroll patients in the coming weeks. "The drug-eluting stent revolution has led us to the point where a randomized comparison of the TAXUS system with surgery in the highest-risk patients is critical," said Dr. Morice. "The results of this study may profoundly change the practice of medicine. I am proud that the Institut Jacques Cartier is the first to enroll a patient in this groundbreaking trial." Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com. This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, regulatory approvals, the commercialization of new technologies, competitive offerings, intellectual property, litigation and other factors described in the Company's filings with the Securities and Exchange Commission.
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