JACC. Cardiovascular interventions · 2008
Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Brodie Bruce R, Stuckey Thomas, Downey William, Humphrey Angela, Bradshaw Barbara, Metzger Chris, Hermiller James, Krainin Fred, Juk Stanley, Cheek Barry, Duffy Peter, Smith Henry, Edmunds John, Varanasi Jay, Simonton Charles A, STENT (Strategic Transcatheter Evaluation of New Therapies) Group
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAngioplasty, Balloon, CoronaryCardiovascular DiseasesConsumer Product SafetyCoronary Artery DiseaseDrug-Eluting StentsFemaleHumansMaleMetalsMiddle AgedMyocardial InfarctionPatient SelectionProduct LabelingProportional Hazards ModelsProspective StudiesProsthesis DesignRegistriesRisk AssessmentSeverity of Illness IndexStentsThrombosisTime FactorsTreatment OutcomeUnited States