From the tct.org site.
by: retireonme
Long-Term Sentiment: Strong Buy 07/19/03 09:28 am
Msg: 1758 of 1775
This is information on the Cypher stent. The authors are noted below. Decide for yourself. The full article can be accessed at tct.org.
Are Cypher Stents Associated with Increased Thrombosis? Perspectives from the Available Data
TCTMD
Authors:
M. B. Leon, J. W. Moses
The FDA approval of the Cypher™ sirolimus-eluting coronary stent on April 24th, 2003 has been met with both excitement and controversy. The anti-restenosis benefits of Cypher™ are profound, consistent across all patient and lesion subgroups studied, and may transform the texture of catheter-based interventional therapies in the future. However, many unresolved issues remain, including guidelines for more widespread clinical applications, economic concerns, and the dissemination of appropriate operator techniques to ensure optimal safety and efficacy. These issues have been compounded by limitations in Cypher™ stent availability, resulting in chronic shortages of necessary quantities and sizes of stents to service the growing clinical demands. Most recently, safety concerns have been widely publicized and have added to the confusion and controversy surrounding this new and potentially breakthrough technology. Sound bites from a "Dear Colleague" letter circulated by Cordis (a Johnson & Johnson company) to all U.S. interventional physicians on July 7th have exploded onto the pages of The New York Times, The Wall Street Journal, and many other medical news forums, suggesting that the Cypher™ stent may be associated with increased thrombosis. The purpose of this editorial comment is to discuss the available data, share some perspectives, and to suggest guidelines for optimal use.
Historically, stent thrombosis (acute and subacute) in bare metal stents has been associated with patient, lesion, and procedural factors. Multiple previous studies have indicated that the frequency of stent thrombosis is increased in poorly deployed stents (underexpansion with incomplete stent strut to vessel wall apposition), multiple stent implantations, smaller vessels, multivessel stenting, after vascular brachytherapy, stents implanted in akinetic infarct zones, in patients who have surgical procedures within 1-2 months after stenting, and in patients who discontinue the assigned chronic antiplatelet regimens (ASA plus thienopyridines for one month with bare metal stents). For instance, the per patient subacute stent thrombosis rate in ARTS (multivessel bare metal stenting) was 3.2%, compared with the more familiar < 1%, often cited as the current standard in less complex patient cohorts. In previous animal studies with the Cypher™ stent, the frequency of stent thrombosis and the timecourse of re-endothelialization was similar to control Bx Velocity™ (bare metal) stents. Human data relating to stent thrombosis is derived from multiple sources: blinded, randomized clinical trials, large prospective registries, and the rapidly accumulating observational reports from U.S. clinical sites, post-FDA approval. These data sources differ in rigor (reporting accuracy and event adjudication), patient populations (simple vs. complex), and operator training and technique.
HERE IS THE END OF THE ARTICLE. PLEASE READ THE ENTIRE ARTICLE.
The introduction of potent new cardiovascular devices with great potential and high expectations to provide incremental patient benefits is never simple or without "dark side" considerations. Over-reaction to the recent claims of increased Cypher™ stent thrombosis are not supported by the facts and should not dampen our long-term enthusiasm for drug-eluting stents. However, these claims cannot be idly dismissed and require a thoughtful response by all concerned parties. We believe that the increased awareness engendered by the current publicity will result in improved interventional operator technique, more careful patient and device selection, and meticulous attention to intra- and post-procedural a |
