Off-label use and the spectre of drug-eluting stent thrombosis.
نویسندگان
چکیده
Off-label use of drug-eluting stents (DES) occurs when the implantation takes place outside the scope of the approved label. In the case of DES, the “on-label” indications are limited to short de novo lesions in coronary arteries measuring 2.5 to 3.75 mm in diameter. As anticipated, the use of paclitaxel-eluting stents (PES) has shown excellent outcomes with low rates of target lesion revascularization at long-term follow-up in on-label indications.1
منابع مشابه
Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group.
OBJECTIVES This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications. BACKGROUND Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied. METHODS The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest mu...
متن کاملImmunosuppressive therapy and tolerance of organ allografts.
Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-23. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-31. Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after ...
متن کاملOutcomes and complications associated with off-label and untested use of drug-eluting stents.
CONTEXT Limited data exist regarding use of drug-eluting stents outside of approved indications in real-world settings. OBJECTIVES To determine the frequency, safety, and effectiveness of drug-eluting stents for off-label (restenosis, bypass graft lesion, long lesions, vessel size outside of information for use recommendation) and untested (left main, ostial, bifurcation, or total occlusion l...
متن کاملTemporal trends in the use of drug-eluting stents for approved and off-label indications: a longitudinal analysis of a large multicenter percutaneous coronary intervention registry.
BACKGROUND We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC). HYPOTHESIS To determine whether the decrease in use of DES has affected both on an...
متن کاملEvidence of safety and effectiveness for a drug-eluting stent: how should we respond this time?
Drug-eluting stents (DES) were introduced to the coronary artery disease treatment market in 2003 with much exuberance and fanfare. With 70% reduction in restenosis and no apparent safety concerns in 1-year reports from large randomized clinical trials,1,2 the opportunity for expansion of the technology seemed limitless. Interventional cardiologists responded with confidence and quickly expande...
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عنوان ژورنال:
- Circulation. Cardiovascular interventions
دوره 2 4 شماره
صفحات -
تاریخ انتشار 2009