FDA weighs in on risks of DES
Even though stent thrombosis (ST) remains a concern with drug-eluting stents (DES), their benefits still outweigh their risks, according to an FDA Circulatory System Devices Advisory Panel. Andrew Farb, MD, of the Office of Device Evaluation at the FDA’s division of cardiovascular devices, discussed the panel’s recommendations at the DES Summit during the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., this week.
The panel had reviewed the risks, timing and incidence of ST associated with two FDA-approved DES – the Cypher sirolimus-eluting stent from Cordis, a subsidiary of Johnson & Johnson, and the Taxus paclitaxel-eluting stent from Boston Scientific.
“Both approved DES are associated with a small increase in ST compared with bare-metal stents that emerges one year after implantation,” Farb said. He added that the increased risk of ST was not associated with an increased risk of death or myocardial infarction (MI), compared with bare-metal stents.
Farb suggested that sample sizes in the pooled studies may not have been large enough to detect death or MI differences between treatment groups.
Several times during his lecture, Farb stressed the need for “larger pre-market clinical trials” with longer follow-ups. He suggested that the FDA would closely follow the outcomes of such trials during the first year following implantation of DES, and in 12-month intervals up to five years.
The panel had reviewed the risks, timing and incidence of ST associated with two FDA-approved DES – the Cypher sirolimus-eluting stent from Cordis, a subsidiary of Johnson & Johnson, and the Taxus paclitaxel-eluting stent from Boston Scientific.
“Both approved DES are associated with a small increase in ST compared with bare-metal stents that emerges one year after implantation,” Farb said. He added that the increased risk of ST was not associated with an increased risk of death or myocardial infarction (MI), compared with bare-metal stents.
Farb suggested that sample sizes in the pooled studies may not have been large enough to detect death or MI differences between treatment groups.
Several times during his lecture, Farb stressed the need for “larger pre-market clinical trials” with longer follow-ups. He suggested that the FDA would closely follow the outcomes of such trials during the first year following implantation of DES, and in 12-month intervals up to five years.