Temporal Trends in the Use of Drug-eluting Stents for Approved and Off-label Indications: A Longitudinal Analysis of a Large Multicenter Percutaneous Coronary Intervention Registry

Background: We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis: To determine whether the decrease in use of DES has affected both on and off-label indications. Methods: The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter Of 2006 (pre-ESC) were compared to those from th fourth quarter Of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated. Results: The overall deployment of DES fell sharply from 83% pre-ESC to a plateau Of 58% in the first quarter Of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected,though it also fell 25% (from 79%-56%). Conclusions: The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.