http://repub.eur.nl/res/aut/2735/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/36962/ 2007-11-01T00:00:00Z Objective: Few trials report event-adjudication procedures in detail. Using data from the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) study, we compared the impact on event-rates of an adjudication strategy based on systematic screening of all reported serious adverse events (SAEs) with a strategy based on investigator diagnoses. The final diagnosis was always made by a critical events committee (CEC) using standard criteria. Methods: ACTION randomized 7665 patients with stable angina to either nifedipine or placebo. Pre-specified events included acute or procedural myocardial infarction (MI), refractory angina, heart failure and debilitating stroke. Clinically related SAEs including in-hospital procedures were combined into episodes independent from the investigator diagnoses entered on SAE reports. All fatal episodes and those episodes suggestive of pre-specified events were adjudicated by the CEC. Results: During follow-up, 17,081 episodes were reported in 5312 patients. The SAE descriptions ruled out the occurrence of a pre-specified event in 28%. The remaining 72% were adjudicated by the CEC and 616 cases of MI, 361 of refractory angina, 275 of heart failure and 190 of debilitating stroke were diagnosed (total = 1442). Had adjudication by the CEC been limited to the 3924 episodes (2397 patients) that were fatal or for which the investigator had reported any of the diagnoses mentioned, 98 cases of MI, 35 of refractory angina, 81 of heart failure and 14 of debilitating stroke would have been missed (total = 228). Conclusion: Both the diagnostic criteria used and the adjudication process determine event-rates and conclusions about treatment effects in clinical trials. Published trial reports should always state if event-adjudication was independent of the diagnoses of investigators, and if all events of interest were adjudicated or only the first one. http://repub.eur.nl/res/pub/5730/ 2004-05-01T00:00:00Z BACKGROUND: Patients with acute coronary syndromes (ACS) complicated by heart failure (HF) are at increased risk of death. Treatment with angiotensin-converting enzyme inhibitors (ACEI), beta-blockers, and early invasive risk stratification are recommended for these patients. AIM: The purpose of the current study was to assess adherence to treatment guidelines of patients with ACS complicated by HF in Europe and the Mediterranean region. METHODS AND RESULTS: Of the 10,484 patients who participated in Euro-Heart ACS survey, 9587 had known HF status and were without cardiogenic shock; 7058 (74%) did not have symptomatic HF and 2529 (26%) presented with or developed symptomatic HF during hospitalization. HF patients were older and had more cardiovascular risk factors. ACEI were more commonly used in HF patients (75% vs 56%, P < .01), whereas beta-blockers were less frequently used (75% vs 82%, P < .01). Coronary angiography and in hospital revascularization rates were lower among HF patients (42% vs 57% for coronary angiography, P < .01, and 32% vs 42% for revascularization, P < .01). Similar trends were noticed among patients with left ventricular dysfunction (symptomatic and asymptomatic).Adjusted in-hospital mortality risk was higher among patients with ACS complicated by symptomatic HF regardless of electrocardiographic type of ACS: (ST-elevation ACS, OR 2.5, 95% CI 1.6-3.9; non-ST-elevation ACS, OR 8.9,95% CI 4.5-17.7; undetermined-ECG ACS, OR 9.3, 95% CI 2.5-34). CONCLUSIONS: Patients with ACS complicated by HF were at increased risk of dying. A relatively high percentage of HF patients were treated with ACEI and beta-blockers in accordance with current recommendations. Rates of coronary angiography and revascularization were significantly lower in ACS patients with HF versus those without HF, which potentially contributed to their worse mortality http://repub.eur.nl/res/pub/9938/ 2002-08-01T00:00:00Z AIMS: To better delineate the characteristics, treatments, and outcomes of patients with acute coronary syndromes (ACS) in representative countries across Europe and the Mediterranean basin, and to examine adherence to current guidelines. METHODS AND RESULTS: We performed a prospective survey (103 hospitals, 25 countries) of 10484 patients with a discharge diagnosis of acute coronary syndromes. The initial diagnosis was ST elevation ACS in 42.3%, non-ST elevation ACS in 51.2%, and undetermined electrocardiogram ACS in 6.5%. The discharge diagnosis was Q wave myocardial infarction in 32.8%, non-Q wave myocardial infarction in 25.3%, and unstable angina in 41.9%. The use of aspirin, beta-blockers, angiotensin converting enzyme inhibitors, and heparins for patients with ST elevation ACS were 93.0%, 77.8%, 62.1%, and 86.8%, respectively, with corresponding rates of 88.5%, 76.6%, 55.8%, and 83.9% for non-ST elevation ACS patients. Coronary angiography, percutaneous coronary interventions, and coronary bypass surgery were performed in 56.3%, 40.4%, and 3.4% of ST elevation ACS patients, respectively, with corresponding rates of 52.0%, 25.4%, and 5.4% for non-ST elevation ACS patients. Among patients with ST elevation ACS, 55.8% received reperfusion treatment; 35.1% fibrinolytic therapy and 20.7% primary percutaneous coronary interventions. The in-hospital mortality of patients with ST elevation ACS was 7.0%, for non-ST elevation ACS 2.4%, and for undetermined electrocardiogram ACS 11.8%. At 30 days, mortality was 8.4%, 3.5%, and 13.3%, respectively. CONCLUSIONS: This survey demonstrates the discordance between existing guidelines for ACS and current practice across a broad region in Europe and the Mediterranean basin and more extensively reflects the outcomes of ACS in real practice in this region http://repub.eur.nl/res/pub/5670/ 2001-12-17T00:00:00Z