On Drug-Eluting Stents- What the FDA has to Say?

This is an update following a two-day US FDA expert panel meeting in December 7 & 8, 2006 regarding clotting risks with these devices. After a rigorous review of available data, it has been concluded that Drug-Eluting Stents are SAFE and EFFECTIVE for the indication for which the approval for its use was based. Simply put, the panel agreed that it is safe to to continue using DES as labelled. While the panelists agreed that there is a slight increased risk of stent thrombosis in DES, the overall risk of myocardial infarction and death is not more than that seen in bare-metal stents.

The ACC/AHA/SCAI recommendation is for 12 months of dual antiplatelet therapy (aspirin plus Plavix [clopidogrel]), which the panel said should be mentioned in the label information, but the panelists shied away from changing the label to require at least 12 months of Atherosclerosis is a progressive disease hence, my personal bias has always been to continue the use of dual antiplatelet therapy indefinitely and the current changing of the guideline extending the duration of antiplatelet regimen post DES implantation has somehow proven me right. It has been my practice long before this issue of stent thrombosis came into the spotlight because I believe that dual antiplatelet is our best defense against heart attack to date. . .

This is purely my personal opinion but I think it is just a matter of time before studies would prove its worth and becomes part of the collective recommendation from the college. While recommendations are available, it is eventually the physician and patient who will have to decide the appropriate duration of dual antiplatelet therapy given the patients unique situation and circumstance. The FDA can only recommend what is best considering the available data and does not in any way regulate physician practices. It is estimated that about 50-60% of DES implantation in the US are considered off-label use. Definitely more studies are needed to address these subgroup of patients for which there is paucity of information regarding safety and appropriate duration of antiplatelet therapy.