BOSTON SCIENTIFIC REPORTS TWO-YEAR SYNTAX TRIAL DATA.Angiotech Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ANPI ANPI Angiotech Pharmaceuticals Inc. (Vancouver, BC, Canada) ANPI Associazione Nazionale Partigiani d'Italia (Italian: National Association of Partisans) has announced that its corporate partner, Boston Scientific (NYSE NYSE See: New York Stock Exchange :BSX BSX Bermuda Stock Exchange BSX Bandai Satellaview-X BSX Bicycle Super-X (Cross) has reported two-year data from its SYNTAX clinical trial comparing percutaneous coronary intervention Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a therapeutic procedure to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. (PCI (1) (Payment Card Industry) See PCI DSS. (2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus). ) using the Taxus(R) Express(R) Paclitaxel-Eluting Coronary Stent System to coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) surgery. The overall results demonstrated no statistically significant difference between PCI and CABG in the composite safety endpoint (all-cause death, stroke and myocardial infarction (MI)). Boston Scientific made the announcement at the annual European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe. (ESC) Congress in Barcelona. "These results reinforce the one-year SYNTAX data and show impressive outcomes for PCI in patients with complex coronary anatomy, the majority of whom are normally treated with CABG surgery," said Keith D. Dawkins, M.D., Associate Chief Medical Officer of Boston Scientific. "Today's findings build on our prior data and provide additional support for PCI as a viable treatment option for many of these challenging patients." The patients in the SYNTAX trial - all of whom have left main and/or three-vessel coronary disease - are a unique study group in the PCI field. In the SYNTAX trial, mean stent use was 4.6 stents/patient, with one patient having 14 stents implanted. By contrast, the average number of stents implanted in a PCI patient in everyday practice is 1.5. In addition, the study included 33 percent of patients with (greater than)100 mm stented length, 71 percent with bi/trifurcations, 27 percent with chronic total occlusions and 39 percent with left main disease. The results showed comparable safety profiles for the two treatment groups at two years, with a combined rate of all-cause death, stroke and MI of 10.8 percent for PCI and 9.6 percent for CABG (p=0.44). The rate of stroke was 1.4 percent for PCI as compared to 2.8 percent for CABG (p=0.03), while MI was 5.9 percent for PCI and 3.3 percent for CABG (p=0.01). The rate of all-cause death was 6.2 percent for PCI and 4.9 percent for CABG (p=0.24). Overall MACCE MACCE Maine Association of Chamber of Commerce Executives MACCE Major Adverse Cardiac and Cerebrovascular event (Major Adverse Cardiovascular or Cerebrovascular cer·e·bro·vas·cu·lar adj. Relating to the blood supply to the brain, particularly with reference to pathological changes. cerebrovascular pertaining to the blood vessels of the cerebrum or brain. Event rate, including all-cause death, stroke, MI and repeat revascularization) was significantly higher for PCI (23.3 percent as compared to 16.4 percent for CABG, p=0.0002), driven largely by the anticipated higher rate of revascularization in the PCI group (17.4 percent as compared to 8.6 percent for CABG, p(less than)0.0001), with the difference narrowing in the second year of follow-up. Most patients requiring repeat revascularization in the PCI group were successfully treated with another PCI. The trial results were also analyzed based on the SYNTAX Score, which demonstrated no statistically significant difference in MACCE for patients in the lower two terciles - those with low lesion complexity (19.4 percent for PCI and 17.4 percent for CABG, p=0.63) and moderate lesion complexity (22.8 percent for PCI and 16.4 percent for CABG, p=0.06). For patients in the upper tercile - those with the most complex disease - there was a significant increase in MACCE for PCI patients as compared to CABG (28.2 percent as compared to 15.4 percent, p=0.001). The SYNTAX Score is a novel angiographic tool used to measure the complexity of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. based on nine anatomic criteria, including lesion frequency, complexity and location. Higher SYNTAX Scores indicate patients with more complex disease and increased treatment challenges. A SYNTAX Score website, www.syntaxscore.com, was launched in May and allows cardiologists and cardiac surgeons to characterize a patient's anatomical complexity, which can be used in combination with a physician's clinical judgment to help determine the best revascularization option. The SYNTAX Score and SYNTAX Score website were developed under the direction of the SYNTAX trial steering committee, chaired by Patrick Serruys, M.D., Ph.D and F.W. Mohr, M.D., Ph.D., and were made possible by support from Boston Scientific and Cardialysis BV. The safety and effectiveness of the TAXUS Express Stent System has not been established in patients with left main or three-vessel disease. About Angiotech Pharmaceuticals Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. For more information, visit http://www.angiotech.com or call 212/850-5761. |
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