Drug-Coated Stents Not Always Best Option
Last month the FDA published a statement in response to inquiries asking for the agency’s position on adverse events related to coronary drug-eluting stents (DES). The agency is “aware of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients treated with DES.” It is monitoring outcomes and working with DES manufacturers to try and stay on top of this issue which can lead to serious adverse outcomes. It also acknowledges that the best use of drugs (specifically the optimal duration of clopidogrel) to prevent clotting in more complex patients has yet to be defined.
Cardiosource, the American College of Cardiology’s journal, now publishes an editorial questioning whether drug-eluting stents are always used appropriately. First, it states that DES offers lower incremental benefits in real world applications to target vessel restenosis than what clinical trials had shown. Second, recent findings suggest “increased risk of late stent thrombosis associated with DES in more complex lesions and patients than evaluated in the initial clinical trials or FDA-approved indications.” The author estimates that more than 2,000 excess deaths per year could be attributable to late stent thrombosis in the United States. Dr. Sanjay Kaul concludes with these recommendations:
“1. Initial DES use in selective patients at high risk for restenosis (for example, smaller diameter vessels or longer lesions where TVR rates generally exceed 15%-20%).
2. Provisional or bailout DES use in those who present with restenosis following BMS.
3. Strict avoidance of DES in those unable or unlikely to comply with long-term dual antiplatelet therapy.”
See also NYT coverage of this issue.
October 12, 2006 Related topics: Quality, Safety, Errors