Abstract 4500: Declining Use of Drug Eluting Stents for Approved and Off-Label Indications
Introduction. Recent studies have raised concerns about an increased risk of late sub-acute thrombosis of drug eluting stents (DES). Though there are indications from industry data that the use of DES has dropped dramatically since the release of these studies, there has been no attempt to quantify whether the decrease has occurred for approved or for off-label indications.
Hypothesis. To determine whether the decrease in use of DES has affected predominantly off-label indications.
Methods. The study cohort included 38,620 patients undergoing PCI between January 2006 and October 2007 in a large regional registry in Michigan (BMC2 registry). Data of DES versus bare metal stent (BMS) use according to different indications was collected. The off-label indications evaluated were ST segment elevation myocardial infarction (STEMI), in stent restenosis (ISR) and saphenous vein graft (SVG) disease.
Results. The overall deployment of DES versus BMS favored DES use approximately 90% of the time, until it fell sharply after September 2006. A plateau (65% use) was reached in March 2007. The STEMI subgroup showed the most dramatic change, from 90% use pre- September 2006, to only 35% at the tail end of the study period. Off- label use in SVG showed a similar trend (from 80% to 45%). DES deployment for ISR remained high at 90% through April 2007.
Conclusion. Except than for ISR, the most pronounced decrease in the use of DES has occurred for non-approved indications including SVG disease and STEMI.