American heart journal · 2008
One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Bertrand Olivier F, Rodés-Cabau Josep, Larose Eric, Nguyen Can Manh, Roy Louis, Déry Jean-Pierre, Courtis Javier, Nault Isabelle, Poirier Paul, Costerousse Olivier, De Larochellière Robert
Аннотация
BACKGROUND: Long-term clinical follow-up has shown a significant benefit after percutaneous coronary intervention (PCI) for abciximab bolus followed by 12-hour infusion over placebo or bolus-only. With contemporary techniques and clopidogrel pretreatment, it is unknown whether the 12-hour infusion is still associated with a clinical benefit. The purpose of this study is to compare 6- and 12-month clinical outcomes in patients treated after PCI with abciximab bolus-only and abciximab bolus followed by 12-hour infusion.
METHODS: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day discharge and no infusion of abciximab (bolus-only group, n = 504) or to overnight hospitalization and 12 hours (0.125 microg/[kg min]) of abciximab infusion (bolus + infusion group, n = 501). The rate of major adverse cardiovascular events (MACE) was evaluated at 30 days, 6 months, and 12 months.
RESULTS: At 30 days, the rate of MACE including death, myocardial infarction, and target vessel revascularization was similar in the 2 groups: 1.4% in the bolus-only group versus 1.8% in the bolus + infusion group (P = .63). At 6 months, the MACE rate was 5.6% in the 2 randomized groups. At 12 months, the MACE rate was also similar in both groups: 8.7% in the bolus-only group and 9.2% in the bolus + infusion group (hazard ratio 0.97, 95% CI 0.79-1.20, P = .80). Similar efficacy was also observed in several subgroups including higher-risk patients such as those with elevated troponin T before PCI.
CONCLUSIONS: In patients pretreated with clopidogrel and undergoing uncomplicated coronary artery stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus-only versus those treated with bolus + infusion, a finding consistent with the initial 30-day outcomes.
METHODS: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day discharge and no infusion of abciximab (bolus-only group, n = 504) or to overnight hospitalization and 12 hours (0.125 microg/[kg min]) of abciximab infusion (bolus + infusion group, n = 501). The rate of major adverse cardiovascular events (MACE) was evaluated at 30 days, 6 months, and 12 months.
RESULTS: At 30 days, the rate of MACE including death, myocardial infarction, and target vessel revascularization was similar in the 2 groups: 1.4% in the bolus-only group versus 1.8% in the bolus + infusion group (P = .63). At 6 months, the MACE rate was 5.6% in the 2 randomized groups. At 12 months, the MACE rate was also similar in both groups: 8.7% in the bolus-only group and 9.2% in the bolus + infusion group (hazard ratio 0.97, 95% CI 0.79-1.20, P = .80). Similar efficacy was also observed in several subgroups including higher-risk patients such as those with elevated troponin T before PCI.
CONCLUSIONS: In patients pretreated with clopidogrel and undergoing uncomplicated coronary artery stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus-only versus those treated with bolus + infusion, a finding consistent with the initial 30-day outcomes.
Предметные рубрики MeSH
AbciximabAgedAngioplasty, Balloon, CoronaryAntibodies, MonoclonalCombined Modality TherapyCoronary AngiographyCoronary StenosisDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansImmunoglobulin Fab FragmentsInfusions, IntravenousLength of StayMaleMiddle AgedPatient DischargePulse Therapy, DrugRadial ArteryReference ValuesRisk AssessmentStentsSurvival RateTime FactorsTreatment Outcome