Drug eluting stents are safe for licensed indications, FDA panel saysBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.39063.481285.DB (Published 14 December 2006) Cite this as: BMJ 2006;333:1235
Drug eluting stents (DES) are safe when used within their licensed indications, a panel of the US Food and Drug Administration advised at a special meeting last week. But the possibility that stents may be associated with increased risk of death and myocardial infarction caused by late stent thrombosis when used off label should be investigated further, it says.
The panel suggested that the increased risk may be related to use of antiplatelet therapy for too short a time in higher risk patients and called for further research to clarify the optimal duration.
The FDA's circulatory systems devices advisory panel held a two day hearing last week to review recent data that indicate a small but significant increased risk of death and myocardial infarction associated with stent thrombosis in patients with drug eluting stents.
A statement released at the end of the hearing said, “At this time, the FDA believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year.”
The panel heard that at least 60% of procedures using drug eluting stents are carried out in patients outside the licensed indications.
The FDA panel said it intends to more formally evaluate the studies suggesting increased risk. It is also interested in the long term follow-up of patients enrolled in the original pivotal stent randomised trials and in patients with more complex conditions (patients with diabetes, acute myocardial infarction, or multiple vessel disease) and lesions (lesions involving arterial bifurcations, the left main coronary artery, and long arterial segments) who are currently being treated in “real world” randomised and registry studies.
The FDA statement said that the panel was also evaluating information on the duration of treatment with clopidogrel, an antiplatelet drug used in combination with aspirin to reduce and prevent clotting in patients given drug eluting stents.
“Although the duration of clopidogrel appeared to be adequate for the selected patients in the original clinical trials conducted to support FDA approval, the agency recognises that the optimal duration of clopidogrel in more complex patients has not been defined.” The panel considered that the duration of clopidogrel administration and patients' compliance with the prescribed regimen “are likely interrelated with patient and anatomical factors that are associated with DES thrombosis.” It advised that additional clinical data are needed to decide the optimal regimen of antiplatelet treatment for patients with DES .
The FDA statement can be found at www.fda.gov/cdrh/news/091406.html.