Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease

Aims: This study tested the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation. Methods and results: The study was an open-label, randomised, controlled, blinded end-point classification trial, employing the PROBE (Prospective Open Treatment and Blinded End Point Evaluation) design. A total of 290 patients (mean age 74.6 +/- 9.6 years) with NSTE-AMI and angiographic evidence of severe and diffuse CAD, not amenable to revascularisation by either coronary surgery or angioplasty, were randomised to atorvastatin 80 mg/day (n = 144) or conventional medical treatment (n = 146). A primary end point event (combination of cardiovascular death, non-fatal acute myocardial reinfarction and disabling stroke within 12 months of randomisation) occurred in 16.0% of patients treated with atorvastatin 80 mg/day and in 26.7% of patients receiving conventional treatment (HR 0.56; 95% CI 0.33-0.93, p = 0.027). The study was not blinded. Consequently, a bias in the assessment of clinical outcome cannot be completely excluded. Conclusions: In conclusion, when compared with a conventional treatment strategy, full-dose therapy with atorvastatin 80 mg/day provides greater protection against ischaemic recurrences after NSTE-AMI in patients with severe, diffuse, non-revascularisable CAD

Smoking cessation interventions after acute coronary syndromes. Results of a cross-sectional survey in the Lazio Region of Italy.

Given the limited research on Italian hospital smoking care practices, a cross-sectional survey was undertaken in April-May 2011 to describe the current status of smoking cessation interventions for ACS patients in cardiovascular institutions of the Lazio Region of Italy. Lazio is a region of central Italy with a resident population of about 5,600,000. According to the data of the Regional Health Authority, about 10.000 patients are admitted for ACS every year in this region of Italy. Acute cardiac care in the region is currently provided by 33 Cardiology Divisions. All of these units were considered as eligible for the survey. The eligible respondent for each unit was the director. A self-report questionnaire was developed based on previous studies that examined the specific features of smoking cessation care provided to hospitalised patients. Questionnaires were forwarded by the Lazio Regional Section of the Italian National Association of Hospital Cardiologists (ANMCO). Completed questionnaires were received from 22 of the 33 eligible Divisions (66%). These 22 responding units currently provide acute care to about 70% of all ACS patients of the region. Responding units were more likely to represent public non-teaching hospitals (p=0.002), while non-responders were mostly from private non-teaching institutions (p=0.04). Response rates were not influenced by the presence of either interventional catheterization laboratory (Cathlab)or cardiac surgery within the hospitals. The survey suggest that most of cardiology units fail to provide recommended smoking care interventions to ACS patients. In particular, brief smoking cessation advice before discharge represents the only systematically implemented approach in clinical practice (22 units; 100%). Smoking cessation counselling is provided only in 9 units (40%). Specific pharmacotherapy is prescribed in selected case only in about one third of units (7 units; 32%), with varenicline being the preferred drug. Structural variables and organizational complexity have no influence on smoking care, as hospitals with Cathlab and cardiac surgery do not implement more effective strategies. Overall, this survey shows that the majority of smoking ACS inpatients may receive inadequate smoking care and that hospitals have considerable opportunity for improvement

Direct Oral Anticoagulants in Patients with Obesity and Atrial Fibrillation: Position Paper of Italian National Association of Hospital Cardiologists (ANMCO)

The use of the direct oral anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban (DOACs) offers some major advantages over warfarin and other vitamin K antagonists (VKAs). One advantage is the possibility to use a fixed dose in normal-weight patients, overweight patients and patients with obesity. However, the “one size fits all” strategy raised a concern regarding the possibility to undertreat patients with a high body mass index. No randomized controlled trials (RCTs) have ever compared VKAs and DOACs in this population. We analyzed data from the literature on DOAC pharmacokinetics and pharmacodynamics, results from the four pivotal phase III trials on non-valvular atrial fibrillation, retrospective observational studies and metanalyses. While we are aware of the limitation imposed by the absence of specific RCTs, we propose the position of the Italian Association of Hospital Cardiologists (ANMCO) on the use of DOACs in patients with obesity based on the existing evidence.</jats:p

Direct Oral Anticoagulants in Patients with Obesity and Atrial Fibrillation: Position Paper of Italian National Association of Hospital Cardiologists (ANMCO)

The use of the direct oral anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban (DOACs) offers some major advantages over warfarin and other vitamin K antagonists (VKAs). One advantage is the possibility to use a fixed dose in normal-weight patients, overweight patients and patients with obesity. However, the “one size fits all” strategy raised a concern regarding the possibility to undertreat patients with a high body mass index. No randomized controlled trials (RCTs) have ever compared VKAs and DOACs in this population. We analyzed data from the literature on DOAC pharmacokinetics and pharmacodynamics, results from the four pivotal phase III trials on non-valvular atrial fibrillation, retrospective observational studies and metanalyses. While we are aware of the limitation imposed by the absence of specific RCTs, we propose the position of the Italian Association of Hospital Cardiologists (ANMCO) on the use of DOACs in patients with obesity based on the existing evidence

ANMCO position paper ‘Appropriateness of prescribing direct oral anticoagulants in stroke and systemic thromboembolism prevention in adult patients with non-valvular atrial fibrillation’

Abstract The appropriateness of prescribing direct oral anticoagulants [dabigatran, rivaroxaban, apixaban, and edoxaban (DOACs)] is regulated on the criteria established in Phase III trials. These criteria are reported in the summary of the product characteristics of the four DOACs. In clinical practice, prescriptions are not always in compliance with established indications. In particular, the use of lower doses than those recommended in drug data sheets is not uncommon. Literature data show that the inappropriate prescription of reduced doses causes drug underexposure and up to a three-fold increase in the risk of stroke/ischaemic transient attack, systemic thromboembolism, and hospitalization. Possible causes of the deviation between the dose that should be prescribed and that prescribed in the real world include erroneous prescription, an overstated haemorrhagic risk perception, and the presence of frail and complex patients in clinical practice who were not included in pivotal trials, which makes it difficult to apply study results to the real world. For these reasons, we summarize DOAC indications and contraindications. We also suggest the appropriate use of DOACs in common clinical scenarios, in accordance with what international guidelines and national and international health regulatory bodies recommend.</jats:p