Long-term outcomes following off-label use of sirolimus-eluting stent
In: Journal of Cardiology, Jg. 62 (2013-09-01), Heft 3, S. 151-157
Online
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Zugriff:
ObjectiveTo clarify the impact of off-label use of drug-eluting stent (DES) on 5-year outcomes.BackgroundStudies on the outcomes of on- vs off-label use of DES have been limited by the duration of observation.MethodsWe analyzed 1937 patients from a multicenter registry that includes 95% of patients with 5-year follow-up data. We defined 10 variables as off-label indications according to the manufacturer's instructions for use, and 1665 of 1937 patients (86.0%) met the criteria for at least 1 off-label indication.ResultsAt 5 years, there were no differences in the rates of death, myocardial infarction (MI), and stent thrombosis between off-label and on-label use. The frequency of major adverse cardiac events (MACE), target lesion revascularization (TLR), non-TL but target vessel revascularization (TVR), and target vessel failure were higher in the off-label only during the first year. Among the off-label, having 2 indications was associated with TVR hazard ratio (HR) 1.62; 95% confidence interval (95%CI), 1.09–2.36 and TLR (HR, 1.90; 95%CI, 1.30–2.85). Moreover, having ≥3 off-label indications increased the risk of MACE (HR, 1.70; 95%CI, 1.23–2.40) compared with on-label use. Thrombosis rates increased with the number of off-label indications; it was 0.32% with 1, 0.69% with 2, and 3.54% with ≥3 off-label indications (p
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Long-term outcomes following off-label use of sirolimus-eluting stent
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Autor/in / Beteiligte Person: | Nakamura, Masato ; Ikari, Yuji ; Kyo, Eishou ; Kotani, Jun-ichi ; Yokoi, Hiroyoshi |
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Zeitschrift: | Journal of Cardiology, Jg. 62 (2013-09-01), Heft 3, S. 151-157 |
Veröffentlichung: | Elsevier BV, 2013 |
Medientyp: | unknown |
ISSN: | 0914-5087 (print) |
DOI: | 10.1016/j.jjcc.2013.03.007 |
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