Boston Scientific was an active participant in the U.S. Food and Drug Administration's (FDA) public meeting of the Circulatory System Devices Advisory Panel on December 7-8, 2006, in Gaithersburg, MD. The goal of the panel, according to the FDA, was to improve our knowledge regarding the incidence and timing of stent thrombosis¦in patients who receive drug-eluting stents. Boston Scientific is committed to working closely with both the interventional community and the FDA to address safety concerns surrounding this revolutionary technology that continues to positively impact the lives of millions of patients worldwide. This article will highlight key points of discussion during the meeting.

Weighing the Benefits and Risks of Drug-Eluting Stents
The FDA opened the meeting by reviewing available data on drug-eluting stents. Both Boston Scientific and Cordis Corporation presented data from randomized controlled clinical trials (RCTs) and real-world registries of the TAXUS® Stent and Cypher® Stent, respectively.

Based on the data presented, FDA advisory panel members reached consensus that the benefits of using drug-eluting stents within the limits of their approved labeling outweigh the risks and there is no increase in rates of death or myocardial infarction (MI) with the devices. For example, in the TAXUS RCTs, patients who received the TAXUS Stent had a 50-percent lower relative risk of re-intervention versus patients who received a bare-metal stent over four years. While not statistically significant, the data also shows that patients who received the TAXUS Stent had an overall trend towards less death and Q-MI than patients who received a bare-metal stent (Figure 1).

The FDA advisory panel debated at length the most appropriate definition of stent thrombosis. Trial protocol definitions, as well as the Academic Research Consortium (ARC) definitions, were discussed extensively. The panel was unable to agree upon which definition should become the new standard, so multiple definitions were used to analyze stent thrombosis during the FDA panel meeting.

The FDA advisory panel was divided on the question of whether late-stent thrombosis (stent thrombosis after one year) is an issue with drug-eluting stents in comparison to bare-metal stents. After much discussion, the panel was in general agreement that drug-eluting stents, when used in accordance with their approved labeling, are associated with increased incidents of late-stent thrombosis. However, this panel agreed that the magnitude of this increase is uncertain and that there was no overall increased risk of stent thrombosis over four years with drug-eluting stents versus bare-metal stents.

Other Key Findings
Comparing use of drug-eluting stents in accordance with their labeled indications versus older bare-metal stents, the FDA advisory panel agreed among other things that drug-eluting stents have:

No increased risk of death or heart attack
Benefits outweighing current safety concerns
Statistically significant reduction in the need for repeat procedures performed

FDA advisory panel members discussed the need for additional data to fully understand these issues. Please go to www.fda.gov for more information on the FDA advisory panel meeting.

Conclusion
Boston Scientific is committed to addressing the recommendations brought forth by the panel, particularly concerning educating medical professionals and patients about the benefits and risks of drug-eluting stents, as well as compiling broad databases in order to better understand drug-eluting stent technology in various patient subsets. To this end, Boston Scientific has almost completed enrollment of the randomized SYNTAX trial comparing the TAXUS® Stent to CABG in patients with complex cases of left-main and/or three-vessel disease.

FDA recommendations based on the panel's guidance will be forthcoming. Boston Scientific remains confident in the safety and efficacy of the TAXUS Stent when used in accordance with its labeling, and hopes its detailed presentation to the panel helped to address concerns raised about drug-eluting stents by putting the benefits and risks of this important therapy in perspective.

For more information on the FDA advisory panel meeting, go to www.fda.gov or Resources for Heathcare Professionals at www.taxus-stent.com

For full directions for use, go to www.taxus-stent.com

Cypher is a trademark of Cordis Corporation.
Sponsored by Boston Scientific Corporation.