A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases.
Background: Patients with coronary heart disease (CHD) and survivors of acute coronary syndrome (ACS) are at very high risk for adverse cardiovascular events. Lowering low-density lipoprotein cholesterol (LDL-C) can reduce the risk, with effective lipid-lowering therapy (LLT) readily available; however, dyslipidemia remains prevalent throughout Europe. Design: The observational Dyslipidemia International Study II (DYSIS II) aimed to identify unmet treatment needs in adult ACS and CHD patients. Data for the seven participating European countries are presented herein. Methods: The study was carried out from December 2012 to November 2014. Use of LLT and attainment of Europeanguideline-recommended LDL-C targets were assessed. For ACS patients, changes in lipid levels and LLT were evaluated 4 months post-hospitalization. Results: Of the 4344 patients enrolled, 2946 were attending a physician visit for the assessment of stable CHD, while 1398 had been hospitalized for an ACS event. In both patient sets, mean LDL-C levels were high (89.5 and 112.5 mg/dl, respectively) and <70 mg/dl target attainment extremely poor. The mean daily statin dosage (normalized to atorvastatin potency) was 27 AE 20 mg for CHD and 22 AE 17 mg for ACS patients. Treatment was intensified slightly for ACS subjects after hospitalization, with the dosage reaching 35 AE 24 mg/day. LDL-C target attainment was higher by the end of the 4-month follow up (30.9% and 41.5% for patients on LLT and without LLT at baseline, respectively; p < 0.05). Conclusion: Elevated blood cholesterol levels are highly prevalent across Europe, with low numbers of coronary patients reaching their recommended LDL-C target. While use of LLT is widespread, there is significant scope for intensifying treatment.
The diagnostic evaluation of acute chest pain has been augmented in recent years by advances in the sensitivity and precision of cardiac troponin assays, new biomarkers, improvements in imaging modalities, and release of new clinical decision algorithms. This progress has enabled physicians to diagnose or rule-out acute myocardial infarction earlier after the initial patient presentation, usually in emergency department settings, which may facilitate prompt initiation of evidence-based treatments, investigation of alternative diagnoses for chest pain, or discharge, and permit better utilization of healthcare resources. A non-trivial proportion of patients fall in an indeterminate category according to rule-out algorithms, and minimal evidence-based guidance exists for the optimal evaluation, monitoring, and treatment of these patients. The Cardiovascular Round Table of the ESC proposes approaches for the optimal application of early strategies in clinical practice to improve patient care following the review of recent advances in the early diagnosis of acute coronary syndrome. The following specific 'indeterminate' patient categories were considered: (i) patients with symptoms and high-sensitivity cardiac troponin <99th percentile; (ii) patients with symptoms and high-sensitivity troponin <99th percentile but above the limit of detection; (iii) patients with symptoms and high-sensitivity troponin >99th percentile but without dynamic change; and (iv) patients with symptoms and high-sensitivity troponin >99th percentile and dynamic change but without coronary plaque rupture/erosion/dissection. Definitive evidence is currently lacking to manage these patients whose early diagnosis is 'indeterminate' and these areas of uncertainty should be assigned a high priority for research.
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