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 multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses. RESULTS: Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months. CONCLUSIONS: Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.
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 multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses. RESULTS: Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months. CONCLUSIONS: Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.
Authors: Joseph P Kilroy; Ali H Dhanaliwala; Alexander L Klibanov; Douglas K Bowles; Brian R Wamhoff; John A Hossack Journal: Ann Biomed Eng Date: 2015-04-17 Impact factor: 3.934
Authors: Vlad V Simianu; Amir L Bastawrous; Richard P Billingham; Ellen T Farrokhi; Alessandro Fichera; Daniel O Herzig; Eric Johnson; Scott R Steele; Richard C Thirlby; David R Flum Journal: Ann Surg Date: 2014-09 Impact factor: 12.969
Authors: Timm Bauer; Christoph A Nienaber; Ibrahim Akin; Karl-Heinz Kuck; Matthias Hochadel; Jochen Senges; Thomas Fetsch; Ulrich Tebbe; Stefan N Willich; Jürgen Stumpf; Georg V Sabin; Sigmund Silber; Gert Richardt; Ralf Zahn Journal: Clin Res Cardiol Date: 2011-03-18 Impact factor: 5.460