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December 2006 FDA Findings

The Panel recognized that with more complex patients, there is an expected increased risk in adverse events in these subsets . The panel generally agreed that off-label use of DES is associated with an increased risk of stent thrombosis, death and MI when compared to on-label use of DES.

The labeling for both approved DES should include reference to the ACC/AHA/SCAI PCI Practice Guidelines, which recommend that patients receive aspirin indefinitely plus a minimum of 3 months (for Cypher patients) or 6 months (for TAXUS patients) of clopidogrel, with therapy extended to 12 months in patients at a low risk of bleeding.

The panel agreed that at least 12 months of dual antiplatelet therapy should be recommended for off-label uses of DES.

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