Lipoprotein(a) and benefit of PCSK9 inhibition in patients with nominally controlled LDL cholesterol

BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains >= 70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk.OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels.METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was = 70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2-111.0 mg/dL).RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [CI]: 0.52-0.90) and 1.11 (95% CI: 0.83-1.49), with treatment-lipoprotein(a) interaction on MACE (P-interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or <= 13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% CI: 0.72-0.92) and 0.89 (95% CI: 0.75-1.06), with P-interaction = 0.43.CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402) (C) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.Cardiolog

Pheochromocytoma as an incidentaloma in severe symptomatic calcified constrictive pericarditis

SCOPUS: no.jinfo:eu-repo/semantics/publishe

Contemporary pre-hospital management of ACS patients: results from the EPICOR study

Cardiolog

Particulate matter and NO2 air pollution trigger ST-elevation myocardial infarction: Results from the Belgian STEMI registry 2009-2013

info:eu-repo/semantics/nonPublishe

One-year and longer dual antiplatelet therapy after an acute coronary syndrome: A Belgian position paper: Endorsed by the belgian interdisciplinary working group of acute cardiology

Acute coronary syndrome patients receive DAPT up to one year after their initial event. Exceptions to the guideline-recommended one-year rule, however, are not uncommon. The reasoning behind shorter treatments, such as unacceptable bleeding risk or urgent surgery, should be well documented in the patient’s charts and discharge letter. Based on recent evidence, patients at high risk for repetitive events should continue on low-dose ticagrelor without a significant interruption at one year and indefinitely in the absence of excess bleeding risk. As there is currently no reimbursement, policy makers and insurers should be made aware of the continuing risk and unmet clinical need in this patient population. Nevertheless, many unsolved questions need to be answered, both through additional analyses from recent trials such as PEGASUS-TIMI 54 or DAPT, as well as new carefully designed clinical studies.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Editor's Choice-The organization of chest pain units: Position statement of the Acute Cardiovascular Care Association

Chest pain units are defined as organizational short stay units with specific management protocols designed to facilitate and optimize the diagnosis of patients presenting with chest pain in the emergency department. The present document is intended to standardize and facilitate the installation of chest pain units nearby to the emergency department or as an integral part of the emergency department. Recommendations on organizational structure, physical and technical requirements and on disease management are presented. More standardized installation and implementation of chest pain units will enhance the quality of chest pain units and improve the quality of care of our chest pain patients

Air pollution and ST-elevation myocardial infarction: A case-crossover study of the Belgian STEMI registry 2009–2013

Background Previous studies have shown that air pollution particulate matter (PM) is associated with an increased risk for myocardial infarction. The effects of air pollution on the risk of ST-elevation myocardial infarction (STEMI), in particular the role of gaseous air pollutants such as NO2 and O3 and the susceptibility of specific populations, are still under debate. Methods All patients entered in the Belgian prospective STEMI registry between 2009 and 2013 were included. Based on a validated spatial interpolation model from the Belgian Environment Agency, a national index was used to address the background level of air pollution exposure of Belgian population. A time-stratified and temperature-matched case-crossover analysis of the risk of STEMI was performed. Results A total of 11,428 STEMI patients were included in the study. Each 10 μg/m3 increase in PM10, PM2.5 and NO2 was associated with an increased odds ratio (ORs) of STEMI of 1.026 (CI 95%: 1.005–1.048), 1.028 (CI 95%: 1.003–1.054) and 1.051 (CI 95%: 1.018–1.084), respectively. No effect of O3 was found. STEMI was associated with PM10 exposure in patients ≥ 75 y.o. (OR: 1.046, CI 95%: 1.002–1.092) and with NO2 in patients ≤ 54 y.o. (OR: 1.071, CI 95%: 1.010–1.136). No effect of air pollution on cardiac arrest or in-hospital STEMI mortality was found. Conclusion PM2.5 and NO2 exposures incrementally increase the risk of STEMI. The risk related to PM appears to be greater in the elderly, while younger patients appear to be more susceptible to NO2 exposure.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Effect of alirocumab on cardiovascular outcomes after acute coronary syndromes according to age: an ODYSSEY OUTCOMES trial analysis

Aims Lowering low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular risk irrespective of age, but the evidence is less strong for older patients.Methods and results This prespecified analysis from ODYSSEY OUTCOMES compared the effect of alirocumab vs. placebo in 18 924 patients with recent acute coronary syndrome (ACS) according to age. We examined the effect of assigned treatment on occurrence of the primary study outcome, a composite of coronary heart disease death, myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization [major adverse cardiovascular event (MACE)] and all-cause death. Relative risk reductions were consistent for patients >= 65 vs. = 75 vs. 0.85, 0.78-0.93 in <75, P-interaction = 0.19). When considering age as a continuous variable in regression models, advancing age increased risk of MACE, as well as the absolute reduction in MACE with alirocumab, with numbers-needed-to-treat for MACE at 3 years of 43 (25-186) at age 45 years, 26 (15-97) at age 75 years, and 12 (6-81) for those at age 85 years. Although adverse events were more frequent in older patients, there were no differences between alirocumab and placebo.Conclusion In patients with recent ACS, alirocumab improves outcomes irrespective of age. Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.Cardiolog

Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary

Item does not contain fulltextRegulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) should be studied separately for therapies aimed at the specific pathophysiology of either condition, particularly for treatment of the acute phase, but can be studied together for other treatments, especially long-term therapy. Unstable angina patients should be excluded from acute phase ACS trials. In general, cardiovascular death and reinfarction are recommended for primary efficacy endpoints; other endpoints may be considered if specifically relevant for the therapy under study. New agents or interventions should be tested against a background of evidence-based therapy with expanded follow-up for safety assessment. In conclusion, new guidance documents for randomized controlled trials in ACS should consider changes regarding patient and endpoint selection and definitions, and trial designs. Specific requirements for the evaluation of novel pharmacological therapies need further clarification