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

Abstract

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 the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as STsegment 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.

Contemporary Use of Prasugrel in Clinical Practice

“…It has been demonstrated that the interventional cardiology community changes its practice rapidly in response to the emergence of new data. 8 In contrast, a slow and steady increase in the overall use of prasugrel was seen during our study period, likely demonstrating a cautionary uptake of this medication. Despite increasing use since Food and Drug Administration approval, the slow adoption of prasugrel may be related to a lack of perceived dramatic clinical benefit or concerns about higher risk of bleeding and cost.…”

Intracoronary Thrombus

“…Data were broken down according to 3 periods in interventional cardiology: an early stent era with Palmaz-Schatz and Gianturco-Roubin stents (January 1990 to December 1996), a bare-metal stent (BMS) era with more flexible and deliverable metal stents and routine use of intravenous and oral antiplatelet agents (January 1997 to March 2003), and a period intended to represent current practice with a rapid and sustained uptake in drug-eluting stent (DES) use, mostly for "off-label" indications (April 2003 to August 2006). An important caveat is that after the presentation of controversial data about long-term safety of DES at the European Congress of Cardiology in September 2006, DES use dropped sharply in the U.S. (10). Furthermore, the data presented in this study precede the U.S. Food and Drug Administration advisory panel meeting on DES safety and the recommendations issued by professional associations regarding the risks of dual antiplatelet therapy discontinuation within 12 months of stent implantation (11).…”

Uso "off label" de Stents Coronarios Medicados: Factores pronósticos en el Seguimiento

“…A partir de ese año disminuyó considerablemente el uso del stent medicado en ese contexto luego del uso indiscriminado observado previamente 4 . En la población de este estudio la incidencia de implantación de stent medicados en indicaciones off-label fue del 61%.…”

“…La condición off-label del paciente comprende un espectro de indicaciones no aprobadas para implantación de los stents entre las cuales se incluyen pacientes con síndrome coronario agudo, lesiones en vasos pequeños (<2,5mm), lesiones largas (>35mm) o enfermedad difusa, tratamiento de la enfermedad de múltiples vasos coronarios, lesiones en bifurcaciones y/o dilatación de oclusiones crónicas, oclusión total, zona de reestenosis y lesiones en zonas de bypass previos 2 . En enero del 2007 la FDA y la SCAI (Society of Coronary Angiography and Interventions) recomendaron considerar cuidadosamente el uso de stent medicados en pacientes con indicación off-label, pues la reacción de la capa media hace del stent medicado un dispositivo potencialmente letal y debe tenerse especial atención en aquellos pacientes previamente tratados 3,4 . A pesar de esto, se estima que un importante porcentaje de los stent medicados implantados tienen indicación offlabel y no hay claridad del impacto que puede tener en el paciente la coexistencia de dos o más indicaciones off-label o el efecto diferencial de las indicaciones off-label que permita predecir el riesgo del paciente.…”