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Original Articles

Drug-Eluting Stents Versus Bare-Metal Stents for Off-Label Indications

A Propensity Score–Matched Outcome Study

David Austin, MRCP; Keith G. Oldroyd, MD, FRCP, FSCAI; Alex McConnachie, PhD; Rachel Slack, MPH; Hany Eteiba, MD, FRCP, FSCAI; Andrew D. Flapan, MD, MRCP; Kevin P. Jennings, FRCP; Robin J. Northcote, MD, FRCP, FFSEM; Alastair C.H. Pell, MD, MRCP; Ian R. Starkey, FRCP and Jill P. Pell, MD, FESC

From the Section of Public Health and Health Policy (D.A., R.S., J.P.P.) and Robertson Centre for Biostatistics (A.M.), University of Glasgow; Western Infirmary (K.G.O.); Glasgow Royal Infirmary (H.E.); Victoria Infirmary (R.J.N.), Glasgow; Edinburgh Royal Infirmary (A.D.F.); Western General Hospital (I.R.S.), Edinburgh; Aberdeen Royal Infirmary (K.P.J.), Aberdeen; and Monklands Hospital (A.C.H.P.), Airdrie, Lanarkshire, United Kingdom.

Correspondence to Jill Pell, MD, FESC, Section of Public Health and Health Policy, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, UK. E-mail j.pell{at}clinmed.gla.ac.uk

Received January 31, 2008; accepted May 15, 2008.

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.

Key Words: angioplasty • coronary disease • stents • myocardial infarction • stents, drug-eluting

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CLINICAL PERSPECTIVE

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

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Circ Cardiovasc Interv 2008 1: 45-52. [Abstract] [Full Text] [PDF]

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