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| 1) ACC.07 Late-Breaking Updates - American College of Cardiology 56th Annual Scientific Session COURAGE Trial - BMS vs. Medical Therapy for stable angina COURAGE trial results were released March 26, 2007 at the ACC.07 meeting in New Orleans, Louisiana. The study was randomized and involved 2287 patients with objective evidence of myocardial ischemia and significant coronary artery disease (CAD) at 50 U.S. and Canadian centers. Between 1999 and 2004, 1149 patients were assigned to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction (MI) during a follow-up period of 2.5 to 7.0 years. Over the median 4.6 year follow-up, 211 primary events occurred in the PCI group and 202 events were observed in the medical-therapy group. Primary outcome rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (p=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%, p=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%, p=0.56); or myocardial infarction (13.2% vs. 12.3%, p=0.33). Conclusion: PCI did not reduce the risk of death, MI, or other major cardiovascular events when added to optimal medical therapy as an initial treatment for patients with stable CAD. A detailed snapshot of the COURAGE trial can be viewed at MedIntelliBase.com by clicking on its name link here within. This SMArt Trial™ summary and over 800 other trial summaries are available to subscribers to MedIntelliBase MarketTracks databases. Contact us to access specific clinical trial and registry summaries of interest to you. Interested in keeping up to date on this issue? Is there another area of interest where you need current, timely clinical research or technology development information? Click here to learn more about our MIB Alerts - A Better Way...to stay up to date. Return to Top |
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2) MedIntelliBase Alerts 
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| 3) Carotid Artery Stenting (CAS) article abstract written by Vicky Hunsicker Sanko, CEO, The Next Phase Endovascular disease is a growing problem in the developing world. The carotid artery disease (CAD) subset is a significant patient group. Recently, there have been significant clinical research developments and findings in the race to improve treatment for people with CAD. Carotid artery stenting (CAS) is currently a relatively new and novel option. Vascular intervention that has been proven in the cardio and peripheral vasculature also shows promise as a procedure for CAD. There are many issues unique to the carotid vasculature that significantly separate CAS from traditional cardio and peripheral interventions. It is critical that Clinicians, whether participating in a multi-center trial or for application within general practice, understand these nuances. Three main clinical issues affect the decision for carotid artery stenting in a candidate patient. First is operator experience. This issue has more direct relation to the procedural outcome than any individual factor or perhaps even all other factors combined. From patient selection, randomization (in trials) and reading of the specific issues unique to each patient with CAD, to the crossing of lesions, use of embolic protection, stent and protection device choice, and the physician’s deployment experience is a key factor. The second key issue is the current level of regulation for this patient group. Carotid artery stenting is one of the most heavily regulated therapeutic procedures in the world, with influence and control emanating from the FDA and other nations’ regulatory health ministries and bodies. Constituents from tertiary care hospitals and local clinics, differing funding guidelines from public or private providers, and finally the specifications of the device manufacturers all weigh heavily on the clinician. Clearly defining patients at “High Risk” for the established surgery procedure, carotid endarterectomy (CEA), is one of the most controversial current tasks. The third main issue is the state of the current device pipeline, in terms of products in development, products awaiting approval, and legally marketed products. With the risk of stroke in a carotid procedure ever-present, any and all precautions are justified and necessary. While embolic protection devices are currently under scrutiny for their “cost-effectiveness,” it has been established that given the proper filter placement in conjunction with operator expertise, favorable outcomes can and do occur. Approximately 700,000 strokes occur in the United States every year. Of this total, 500,000 are first-time events for new patients while 200,000 are recurrent in patients that suffered prior stroke events. It is estimated that 25% of all strokes are caused by carotid artery disease (CAD). In the US alone, the market for stroke prevention caused by CAD and suitable for carotid vascular therapy is about 175,000 procedures per year. This can be further broken down by treatment type: surgery, vascular intervention or some form of drug treatment. Demographically, there are a number of factors that determine who suffers from carotid artery disease and who does not. With these factors patients fall into groups that are more appropriately suited for certain procedures over others. In the U.S., CAS for example is currently prescribed for “high risk” patients only. The latest offshoot of the Framingham study is an example of what work is being undertaken to further understand which demographic factors can predict outcomes. Other trials have studied the issue based on race, sex, and certain health factors. Interested in keeping up to date on this issue? The full, frequently updated Carotid Artery Stenting article is available upon request when you sign-up for our custom MIB Alerts tour. Click here to request your copy of the article - please be sure to indicate your interest in the full CAS article in the comments box. Is there another area of interest where you need current, timely clinical research or technology development information? Click here to learn more about our MIB Alerts - A Better Way...to stay up to date. Return to Top |
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4) Link of the Month
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5) Fun Fact of the Month
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| 6) MedIntelliBase Custom Email Alerts now give you A Better Way New feature just added - full-featured search capabilities in your subscribed libraries. Search any or all of these databases:
Does this "quest for Market Intelligence" sound familiar?
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| 8) More Information Available at www.MedIntelliBase.com You can find more in-depth information about MedIntelliBase Custom Email Alerts - visit the website at www.MedIntelliBase.com or request more information on the site. MedIntelliBase MarketTracks and Alerts will help you find the critical intelligence you need to make informed product development and business investment decisions. Contact MedIntelliBase directly... Return to Top |
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FYI:
Editor: Vicky Hunsicker Sanko The Next Phase Publishing** Phone - 425/869-8724 Market Research Analyst: Jordan Zornes The Next Phase Publishing** Phone - 425/894-4147 www.MedIntelliBase.com Toll Free - 800/390-2756 Fax - 866/381-6119 ** A division of Next Phase® Consultancy, Inc. © The Next Phase® Consultancy, Inc. 2007. All rights reserved. Return to Top |
