Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial.

BACKGROUND: Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI. STUDY DESIGN: The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding. CONCLUSIONS: The AIDA STEMI study addresses important questions regarding the efficacy and safety of intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.

Antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome in the real world: Data from the Berlin AFibACS Registry.

BACKGROUND: Guidelines for the management of atrial fibrillation (AFib) recommend antithromboembolic treatment strategies for patients with AFib and acute coronary syndrome (AFibACS). Our study assessed how current guidelines are implemented in the metropolitan area of Berlin and which therapeutic options were chosen in light of stroke and bleeding riskin everyday practice. METHODS AND RESULTS: Between April 2008 and January 2012, we included 1,295 AFibACS patients in the AFibACS Registry, as part of the Berlin Myocardial Infarction Registry. Meanage of the patients was 76 years with numerous comorbidities (15.4% former stroke, 35.0% renal failure, 43.5% diabetes, 92.8% hypertension). Of all the patients, 888 were treated with stent implantation, 91 with balloon angioplasty, and 316 conservatively. Overall mortality was 11.6%, and 8.3% in stented patients. At hospital discharge, triple therapy was administered to 49.9% of stented cases. After adjustment, odds of receiving triple therapy were lower within creasing age and renal failure. Odds were higher after stent implantation, with a higher CHA2DS2-VASc score, and with any AFib category compared to initially diagnosed AFib. Between 2008 and 2011, triple therapy increased from 33.3% to 49.8% for stented patients and did not change significantly for those treated conservatively or with balloon angioplasty. CONCLUSIONS: These data suggest that in AFibACS patients, antithrombotic treatment focused on dual antiplatelet therapy for ACS, rather than on anticoagulation therapy for stroke prevention. Factors influencing therapy at discharge were age, renal failure, stent implantation, AFib category, and CHA2DS2-VASc score. During the study period, triple therapy increased for stented patients.

Time of admission, quality of PCI care, and outcome of patients with ST-elevation myocardial infarction.

OBJECTIVE: Our study aimed to analyse the hospital mortality of patients admitted in- and off-regular working hours with ST-elevation myocardial infarction (STEMI) within the special logistical setting of the urban area of the city of Berlin. BACKGROUND: There is a debate whether patients with acute myocardial infarction admitted to hospital outside regular working hours experience higher mortality rates than those admitted within regular working hours. METHODS: This study analyses data from the Berlin Myocardial Infarction Registry and comprises 2,131 patients with STEMI and treated with percutaneous coronary intervention (PCI) in 2004-2007. Data of patients admitted during in- and off-regular working hours were compared. RESULTS: There was significant difference in door-to-balloon time (median in-hours: 79 min; median off-hours: 90 min, p < 0.001) and in hospital mortality (in-hours: 4.3%; off-hours: 6.8%, p = 0.020) between STEMI patients admitted in- and off-hours for treatment with PCI. After adjustment, admission off-hours remained an independent predictor for in-hospital death for patients (OR = 2.50; 95% CI 1.38-4.56). In patients with primary care from physician-escorted Emergency Medical Services (EMS), door-to-balloon time was reduced by 10 min for in-hours as well as off-hours patients. The difference in hospital mortality between off-hour and in-hour admission was reduced to a non-significant OR = 1.61 (95% CI 0.79-3.27). CONCLUSIONS: In conclusion, patients admitted off-hours experienced longer door-to-balloon times and higher hospital mortality than did those admitted in-hours. The differences observed between patients admitted in-hours and off-hours were reduced through physician-escorted EMS reflecting the influence of optimized STEMI care.