Drug-Eluting Stents Versus Bare-Metal Stents for Off-Label Indications: A Propensity Score–Matched Outcome Study

• Published in: Circulation. Cardiovascular interventions Vol. 1; no. 1; pp. 45 - 52
• Main Authors: Austin, David, Oldroyd, Keith G, McConnachie, Alex, Slack, Rachel, Eteiba, Hany, Flapan, Andrew D, Jennings, Kevin P, Northcote, Robin J, Pell, Alastair C.H, Starkey, Ian R, Pell, Jill P
• Format: Journal Article
• Language: English
• Published: United States American Heart Association, Inc 01.08.2008
• Subjects: Aged; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - mortality; Cohort Studies; Coronary Occlusion - therapy; Drug-Eluting Stents - adverse effects; Drug-Eluting Stents - statistics & numerical data; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Off-Label Use - statistics & numerical data; Propensity Score; Registries; Scotland; Survival Analysis; Treatment Outcome; Scotland
• ISSN: 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.108.769042

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.