Drug-Eluting Stents Reviewed by AHRQ, FDA
A study conducted by researchers at Duke University Medical Center, funded by the Agency for Healthcare Research and Quality (AHRQ) and published in JAMA suggests that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. Currently, instructions for the use of drug-eluting stents commercially available in the U.S. specify treatment with clopidogrel (the active component in BMS’ Plavix) for at least 3 months (for sirolimus-coated stents) or 6 months (for paclitaxel-coated stents) after implantation. The study concluded that extended use of clopidogrel in patients with drug-eluting stents (DES) may be associated with a reduced risk for death and death or myocardial infarction (MI). It will only be possible to properly assess how long to use the drug through a large-scale randomized clinical trial. Evaluating the long-term risks of using clopidogrel was outside of the scope of this research.
Meanwhile the FDA is hosting panel meetings today and tomorrow with drug-coated stent manufacturers. Bloomberg News is underlining that six physicians with financial ties to device makers will serve on the panel. Some of the questions on the agenda:
- “When used in accordance with their labeled indications, are DES associated with an increased rate of stent thrombosis, death, or myocardial infarction compared to bare metal stents?
- Do the current data support a recommendation for an extended duration of dual antiplatelet therapy?
- The pivotal randomized trials of CYPHER and TAXUS submitted for FDA approval primarily involved use of DES in non-complex patients and lesions. Following these approvals, it is estimated that a majority of DES are implanted in lesions outside of their current indications for use, such as in-stent restenosis lesions, bifurcation lesions, coronary artery bypass grafts, acute myocardial infarction, chronic total occlusions, overlapping and multiple stents per vessel and in patients with multivessel disease and chronic renal insufficiency. Given currently available data, are there safety concerns regarding stent thrombosis, death, and myocardial infarction rates for DES use in these complex patients and lesions?”
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December 7, 2006 Related topics: Medical Devices & Products, Quality, Safety, Errors, Cardiology