Abstract 4482: Impact of Long-Term Safety Data and FDA Warnings on Drug-Eluting Stent Use in Clinical Practice: A Report from the ACC/National Cardiovascular Data Registry
In September 2006, several retrospective post hoc analyses showed an association between drug-eluting stent (DES) use and late mortality. Based on the available data, the FDA issued a warning in December 2006 stating that DES appear safe when used “on-label” but their safety in off-label situations was unclear. We queried the ACC/national cardiovascular data registry to determine the impact of those 2 events on DES use. A total of 1,573,276 procedures were analyzied. Starting in quarter 3 of 2003, DES percentage rose to 90% by 2005 and remained near 90% until 4th quarter 2006 when it began a steady decline to 65% by the last quarter of 2007. This decline was not uniform in all subgroups. (in all cases p<.0001 from 2005 to 2007) Percentage use of DES was greater in patients ≤ age 75 (P<0.0002), in-stent restenosis (p<.0001), with diabetes (p<.0001), ACS-Not STEMI (p<.0001), not chronic total occlusion (p<.0001, and not a vein graft (p<.0344) than in the corresponding subgroup in 2007. With limited data on long-term safety, there was early rapid acceptance of DES into clinical practice. Post hoc data analyses presented in 9/06 along with an FDA warning in 12/06 had a substantial impact on DES use, particularly in certain subgroups. The wide fluctuations in interventional practice patterns underscore the need for long term prospective studies of outcomes to determine the appropriate use of emerging technologies..