Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study

Austin, D. et al. (2008) Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study. Circulation: Cardiovascular Interventions, 1(1), pp. 45-52. (doi: 10.1161/CIRCINTERVENTIONS.108.769042)

Abstract

Background-The US Food and Drug Administration recently concluded that data on off-label drug-eluting stent (DES) safety are limited. However, in actual clinical practice, DES are often used for off-label indications, and observational studies demonstrate that complications are higher when compared with on-label use. We aimed to determine whether clinical outcomes differ after DES and bare-metal stent implantation in a patient cohort defined by DES off-label indications. Methods and Results-We used the national revascularization registry in Scotland to identify patients who underwent coronary stenting for an off-label indication between January 2003 and September 2005. Individual-level linkage to comprehensive national admission and death databases was used to ascertain the end points of death, myocardial infarction, and target-vessel revascularization. We calculated propensity scores on the basis of clinical, demographic, and angiographic variables and matched DES to bare-metal stents on a 1:1 basis. The final study population consisted of 1642 patients, well matched for important covariables at baseline. Event-free survival was calculated over 24 months with the Kaplan-Meier method. All-cause death was more common after bare-metal stent implantation during follow-up (7.7% versus 6.6%; hazard ratio 0.63; 95% confidence interval, 0.40 to 0.99; P=0.04). No difference in the rates of myocardial infarction were noted (7.3% versus 7.5%; hazard ratio 1.02; 95% confidence interval, 0.69 to 1.54; P=0.92). Target-vessel revascularization was reduced in patients treated with DES (13.9% versus 10.7%; hazard ratio 0.67; 95% confidence interval, 0.49 to 0.93; P=0.02). Conclusions-At 24 months, patients treated with DES for off-label indications had lower rates of death and target-vessel revascularization and similar rates of myocardial infarction, as compared with patients treated with bare-metal stents. (Circ Cardiovasc Intervent. 2008;1:45-52.)

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McConnachie, Professor Alex and Jennings, Mr Kevin and Oldroyd, Dr Keith and Eteiba, Professor Hany and Pell, Professor Jill
• Authors: Austin, D., Oldroyd, K.G., McConnachie, A., Slack, R., Eteiba, H., Flapan, A.D., Jennings, K., Northcote, R.J., Pell, A.C.H., Starkey, I.R., and Pell, J.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Centre for Population and Health Sciences
• Journal Name: Circulation: Cardiovascular Interventions
• Publisher: American Heart Assocation
• ISSN: 1941-7640