A systematic assessment of the characteristics of randomized controlled trials cited by acute coronary syndrome clinical practice guidelines.

AIMS: The aim of this study was to describe the methodological features of the randomized controlled trials (RCTs) cited in American and European clinical practice guidelines (CPGs) for ST elevation myocardial infarction (STEMI) and non-ST elevation acute coronary syndrome (NSTE-ACS). METHODS AND RESULTS: Out of 2128 non-duplicated references cited in the 2013 and 2014 American College of Cardiology/American Heart Association and 2017 and 2020 European Society of Cardiology CPGs for STEMI and NSTE-ACS, we extracted data for 407 RCTs (19.1% of total references). The majority were multicenter studies (81.8%), evaluated pharmacological interventions (63.1%), had a 2-arm (82.6%), and superiority (90.4%) design. Most RCTs (60.2%) had an active comparator, and 46.2% were funded by industry. The median observed sample size was 1001 patients (84.2% of RCTs achieved ≥80% of the intended sample size). Most RCTs had a single primary outcome (90.9%), which was a composite in just over half (51.9%). Among the RCTs testing for superiority, 44.0% reported a P-value of ≥0.05 for the primary outcome and 61.9% observed a risk reduction of >15%. The observed treatment effect was lower-than-expected in 67.6% of RCTs, with 34.4% having at least a 20% lower-than-expected treatment effect. The calculated post hoc statistical power was ≥80% for 33.9% of cited RCTs. CONCLUSIONS: This analysis demonstrates that RCTs cited by CPGs can still have significant methodological issues and limitations, highlighting that a better understanding of the methodological aspects of RCTs is crucial in order to formulate recommendations relevant to clinical practice.

Epidemiology, monitoring, and treatment strategy in cardiogenic shock. A multinational cross-sectional survey of ESC-acute cardiovascular care association research section.

AIMS: Cardiogenic shock (CS) is a life-threatening condition burdened by mortality in up to 50% of cases. Few recommendations exist with intermediate-low level of evidence on CS management and no data on adherence across centres exist. We performed a survey to frame CS management at multinational level. METHODS AND RESULTS: An international cross-sectional survey was created and approved by European Society of Cardiology-Acute Cardiovascular Care Association board. A total of 337 responses from 60 countries were obtained. Data were assessed by the hospital level of care of the participants. The most common cause of CS was AMI (AMI-CS-79.9%) with significant difference according to hospital levels (P = 0.001), followed by acutely decompensated heart failure (HF) (13.4%), myocarditis (3.5%), and de novo HF (1.75%). In 37.8%, percutaneous coronary intervention (PCI) is performed to all CS-patients as a standard approach, whereas 42.1% used PCI if electrocardiogram suggestive of ischaemia and 20.1% only if Universal definition of myocardial infarction criteria are fulfilled. Management (catecholamine titration and mechanical circulatory support escalation) is driven by mean arterial pressure (87.1%), echocardiography (84.4%), and lactate levels (83.4%). Combination of vasopressor and inotrope is chosen with the same frequency (37.7%) than inotrope alone as first-line pharmacological therapy (differences amongst hospital levels; P > 0.5). Noradrenaline is first-line vasopressor (89.9%) followed by dopamine (8.5%), whereas dobutamine is confirmed as the first-line inotrope (65.9%). CONCLUSION: Cardiogenic shock management is heterogenous and often not adherent to current recommendations. Quality improvement on an international level with evidence-based quality indicators should be developed to standardize diagnostic and therapeutic pathways.

EURObservational Research Programme: a bibliometric assessment of its scientific output.

AIMS: Given the lack of reliable observational data, a network of volunteer centres, and standardized methodological procedures, the European Society of Cardiology EURObservational Research Programme (EORP) was set up to provide a better understanding of real-world cardiovascular care and outcomes. We aimed to evaluate the scientific impact of EORP using a bibliometric approach. METHODS AND RESULTS: We collected data for each individual publication and for each individual journal with at least one EORP publication. Bibliometric indicators evaluating research performance were categorized into those evaluating EORP publications (publication-based indicators) and those assessing the journals where those papers were published (journal-based indicators). During the first ∼11 years since its inception, we found that EORP produced 189 publications, with most published in journals in the first quartile (60.9%) or the second quartile (33.5%) of the Web of Science Journal Citation Report. The total number of citations to EORP publications was 9630 (average citation per publication of 51, h-index of 54, and 29 EORP publications with ≥100 citations). Of EORP publications, 20 had an Altmetric Attention Score >50 and 9 had a score >100. A total of 52 EORP papers have been cited 65 times in ESC Clinical Practice Guidelines between 2013 and 2021. CONCLUSION: EORP registries have contributed to impactful scientific knowledge. The high-quality metrics highlight the relevance of the EORP international cardiovascular registries to the academic community. Efforts are needed to support this, and other programmes aimed at delivering real-world evidence from independent patient data of cardiovascular care and outcomes across multiple geographies.

The Clinical outcomes, healthcare resource utilization, and related costs (COHERENT) model. Application in heart failure patients.

INTRODUCTION AND OBJECTIVES: Composite endpoints are widely used but have several limitations. The Clinical outcomes, healthcare resource utilization and related costs (COHERENT) model is a new approach for visually displaying and comparing composite endpoints including all their components (incidence, timing, duration) and related costs. We aimed to assess the validity of the COHERENT model in a patient cohort. METHODS: A color graphic system displaying the percentage of patients in each clinical situation (vital status and location: at home, emergency department [ED] or hospital) and related costs at each time point during follow-up was created based on a list of mutually exclusive clinical situations coded in a hierarchical fashion. The system was tested in a cohort of 1126 patients with acute heart failure from 25 hospitals. The system calculated and displayed the time spent in each clinical situation and health care resource utilization-related costs over 30 days. RESULTS: The model illustrated the times spent over 30 days (2.12% in ED, 23.6% in index hospitalization, 2.7% in readmissions, 65.5% alive at home, and 6.02% dead), showing significant differences between patient groups, hospitals, and health care systems. The tool calculated and displayed the daily and cumulative health care-related costs over time (total, €4 895 070; mean, €144.91 per patient/d). CONCLUSIONS: The COHERENT model is a new, easy-to-interpret, visual display of composite endpoints, enabling comparisons between patient groups and cohorts, including related costs. The model may constitute a useful new approach for clinical trials or observational studies, and a tool for benchmarking, and value-based health care implementation.

Assessment of the ESC quality indicators in patients with acute myocardial infarction: a systematic review.

AIMS: To help improving quality of care in patients with acute myocardial infarction (AMI), the European Society of Cardiology (ESC) set 20 quality indicators (QIs). There is a need to compile and summarize QI availability, feasibility, and global compliance in real-world registries. METHODS AND RESULTS: A systematic review of PubMed and Web of Science was conducted including all original articles reporting the use of the ESC QIs in AMI patients. Methods and reporting follow the guidelines of the PRISMA Statement and the protocol was registered in PROSPERO (CRD42020190541). Among the 220 screened citations, 9 studies met the inclusion criteria after full-text review. Among these 9 studies, there were 11 different cohorts. Patients were recruited from three different continents (31 countries). The number of QIs assessed ranged from 6 to 20, with 5 studies (56%) reporting data for at least 75% of the 20 QIs. There were room for improvement in terms of data availability (i.e. domain 6 measuring patient's satisfaction), feasibility (i.e. difficulties to find all data for composite QIs in domain 7), and attainment (i.e. high levels of compliance with the percentage of reperfused ST-segment elevation myocardial infarction patients, but low levels for a timely reperfusion). CONCLUSIONS: Our systematic review has shown that it is possible to measure most QIs in existing registries, and that there is room for improvement in terms of data availability, feasibility, and levels of attainment to QIs. Our findings may influence the design of future registries to capture this information and help in QIs definition updates.

Assessment of quality indicators for acute myocardial infarction management in 28 countries and use of composite quality indicators for benchmarking.

BACKGROUND: The European Society of Cardiology established a set of quality indicators for the management of acute myocardial infarction. Our aim was to evaluate their degree of attainment, prognostic value and potential use for centre benchmarking in a large international cohort. METHODS: Quality indicators were extracted from the long-tErm follow-uP of antithrombotic management patterns In acute CORonary syndrome patients (EPICOR) (555 hospitals, 20 countries in Europe and Latin America, 2010-2011) and EPICOR Asia (218 hospitals, eight countries, 2011-2012) registries, including non-ST-segment elevation acute myocardial infarction (n=6558) and ST-segment elevation acute myocardial infarction (n=11,559) hospital survivors. The association between implementation rates for each quality indicator and two-year adjusted mortality was evaluated using adjusted Cox models. Composite quality indicators were categorized for benchmarking assessment at different levels. RESULTS: The degree of attainment of the 17 evaluated quality indicators ranged from 13% to 100%. Attainment of most individual quality indicators was associated with two-year survival. A higher compliance with composite quality indicators was associated with lower mortality at centre-, country- and region-level. Moreover, the higher the risk for two-year mortality, the lower the compliance with composite quality indicators. CONCLUSIONS: When EPICOR and EPICOR Asia were conducted, the European Society of Cardiology quality indicators would have been attained to a limited extent, suggesting wide room for improvement in the management of acute myocardial infarction patients. After adjustment for confounding, most quality indicators were associated with reduced two-year mortality and their prognostic value should receive further attention. The two composite quality indicators can be used as a tool for benchmarking either at centre-, country- or world region-level.

Assessment of Inducible Myocardial Ischemia, Quality of Life, and Functional Status After Successful Percutaneous Revascularization in Patients With Chronic Total Coronary Occlusion.

The benefits of chronic total coronary occlusion (CTO) revascularization are not well established. In this prospective cohort study, 47 consecutive patients with successful percutaneous recanalization of CTO underwent adenosine stress cardiac magnetic resonance (CMR), 6-minute walk test (6MWT), and the Short Form-36 Health Survey before and 6 months after the procedure. Successful recanalization of a CTO was followed by significant improvement of (1) global physical and mental health status; (2) the distance walked in the 6MWT; (3) the incidence of chest pain at the end of the 6MWT; and (4) the score of a novel CMR ischemic burden index on the basis of the characteristics of adenosine stress perfusion defects (extension, persistence, transmurality, and induced contractile regional dysfunction). Patients with greater CMR ischemic index before percutaneous revascularization showed better improvement in the 6MWT. In conclusion, successful recanalization of a CTO leads to a concurrent improvement in ischemic burden, exercise tolerance, angina frequency, and quality of life scores. Patients with a high ischemic CMR score before CTO recanalization showed the better improvement in exercise tolerance.