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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

Dennis T. Ko, MD, MSc^_*,,_*, Maria Chiu, MSc, Helen Guo, MSc, Peter C. Austin, PhD, Ron Goeree, MA, Eric Cohen, MD^_*, Marino Labinaz, MD^,|| and Jack V. Tu, MD, PhD^_*,

^_* Division of Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
Programs for Assessment of Technology in Health Research Institute, St. Joseph's Healthcare, Hamilton, Ontario, Canada
^|| University of Ottawa Heart Institute, Ottawa, Ontario, Canada

Manuscript received October 13, 2008; revised manuscript received December 3, 2008, accepted January 6, 2009.

^_* Reprint requests and correspondence: Dr. Dennis T. Ko, Institute for Clinical Evaluative Sciences G1-06, 2075 Bayview Avenue, Toronto, Ontario, Canada M4N 3M5 (Email: dennis.ko{at}ices.on.ca).

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

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J. Am. Coll. Cardiol. 2009 53: A30. [Full Text] [PDF]