Importance of Antiplatelet Therapy with Drug-Eluting Stents

Sept. 2005 - FDA has received a number of reports of adverse events that occurred in patients who received drug-eluting coronary stents and then stopped taking their antiplatelet medication prematurely. These events included stent thrombosis, MI and death, and they occurred in patients who received both of the currently marketed drug-eluting stents: the Cypher stent system made by Cordis Corp., and the Taxus stent system, made by Boston Scientific Corp.

Sometimes these events occurred when patients stopped antiplatelet therapy early because of non-compliance. In other cases, practitioners asked the patient to stop the medication because they were going to have elective surgical or dental procedures, or because the patient experienced minor bleeding.

As a result, both Cordis and Boston Scientific have now changed the labeling for their drug-eluting stents to emphasize the importance of patient compliance with the antiplatelet recommendations and the risks of prematurely discontinuing antiplatelet therapy.

The labeling also points out that physicians should carefully consider whether a drug eluting stent is the treatment of choice if the patient is anticipating a surgical or dental procedure that might require stopping antiplatelet therapy.

If a surgical or dental procedure is recommended after the stent is implanted, the risks and benefits of the procedure should be weighed against the possible risk associated with prematurely discontinuing antiplatelet therapy. And finally, patients who must stop antiplatelet therapy early should be carefully monitored for cardiac events. At the discretion of the treating physician, antiplatelet medication should be restarted as soon as possible.

Category:

News & Politics

Tags:

• Antiplatelet
• Therapy
• Drug-Eluting
• Stents
• FDA
• Death
• MI
• Cypher
• Taxus
• Patient
• Safety