Clinical Research
Interventional Cardiology
Safety and Effectiveness of Drug-Eluting and Bare-Metal Stents for Patients With Off- and On-Label Indications

https://doi.org/10.1016/j.jacc.2009.01.059Get rights and content
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Objectives

Our main objective was to evaluate the longer-term safety and efficacy of drug-eluting stents (DES) in off-label indications as compared with bare-metal stents (BMS).

Background

DES are frequently implanted in patients with off-label indications. However, the longer-term safety and effectiveness of DES among patients with off-label indications are not well understood.

Methods

Propensity score matching analysis was performed in a population-based cohort that included 6,944 off-label and 9,126 on-label patients who received percutaneous coronary interventions (PCIs) in Ontario, Canada, between December 1, 2003, and March 31, 2006. Off-label indications were defined on the basis of clinical and procedural characteristics.

Results

For patients with off-label indications, rates of repeat target vessel revascularization at 3 years were significantly lower among patients treated with DES compared with those treated with BMS (11.6% vs. 15.3%, p < 0.001). Myocardial infarction rates were not significantly different between patients treated with DES and BMS (p = 0.52). Mortality rates were significantly lower among off-label patients treated with DES compared with BMS at 3 years of follow-up (6.9% vs. 10.5%, p < 0.001). For patients with on-label indications, the use of DES was associated with significantly lower rates of target vessel revascularization, but composite rates of myocardial infarction or death were not significantly different from BMS.

Conclusions

For patients with off-label indications, DES implantation was associated with lower target vessel revascularization without an associated increase in longer-term risk of myocardial infarction or death compared with BMS.

Key Words

drug-eluting stent
off-label indication
cardiovascular outcomes

Abbreviations and Acronyms

BMS
bare-metal stent(s)
CCN
Cardiac Care Network
DES
drug-eluting stent(s)
FDA
Food and Drug Administration
PCI
percutaneous coronary intervention
STEMI
ST-segment elevation myocardial infarction

Cited by (0)

Funded in part by operating grants from the Canadian Institutes of Health Research (CIHR) and a CIHR Team Grant in Cardiovascular Outcomes Research. The Institute for Clinical Evaluative Sciences (ICES) is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). Dr. Ko is supported by a Clinician-Scientist award from the Heart and Stroke Foundation of Ontario. Dr. Austin is supported by a New Investigator Award from the Canadian Institutes of Health Research. Dr. Tu is supported by a Canada Research Chair in Health Services Research and a Career Investigator Award from the Heart and Stroke Foundation of Ontario. Dr. Cohen has served on advisory boards with Abbott Vascular, Medtronic, and Boston Scientific; and he has received speakers' honoraria from Abbott Vascular and Medtronic.