AIMS: To investigate the impact of patiromer on the serum potassium level and its ability to enable specified target doses of renin-angiotensin-aldosterone system inhibitor (RAASi) use in patients with heart failure and reduced ejection fraction (HFrEF). METHODS AND RESULTS: A total of 1642 patients with HFrEF and current or a history of RAASi-related hyperkalemia were screened and 1195 were enrolled in the run-in phase with patiromer and optimization of the RAASi therapy [≥50% recommended dose of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, and 50 mg of mineralocorticoid receptor antagonist (MRA) spironolactone or eplerenone]. Specified target doses of the RAASi therapy were achieved in 878 (84.6%) patients; 439 were randomized to patiromer and 439 to placebo. All patients, physicians, and outcome assessors were blinded to treatment assignment. The primary endpoint was between-group difference in the adjusted mean change in serum potassium. Five hierarchical secondary endpoints were assessed. At the end of treatment, the median (interquartile range) duration of follow-up was 27 (13-43) weeks, the adjusted mean change in potassium was +0.03 mmol/l in the patiromer group and +0.13 mmol/l in the placebo group [difference in the adjusted mean change between patiromer and placebo: -0.10 mmol/l (95% confidence interval, CI -0.13, 0.07); P < 0.001]. Risk of hyperkalemia >5.5 mmol/l [hazard ratio (HR) 0.63; 95% CI 0.45, 0.87; P = 0.006), reduction of MRA dose (HR 0.62; 95% CI 0.45, 0.87; P = 0.006), and total adjusted hyperkalemia events/100 person-years (77.7 vs. 118.2; HR 0.66; 95% CI 0.53, 0.81; P < 0.001) were lower with patiromer. Hyperkalemia-related morbidity-adjusted events (win ratio 1.53, P < 0.001) and total RAASi use score (win ratio 1.25, P = 0.048) favored the patiromer arm. Adverse events were similar between groups. CONCLUSION: Concurrent use of patiromer and high-dose MRAs reduces the risk of recurrent hyperkalemia (ClinicalTrials.gov: NCT03888066).

• MeSH
• antagonisté mineralokortikoidních receptorů škodlivé účinky   MeSH
• draslík MeSH
• hyperkalemie * farmakoterapie   komplikace   MeSH
• lidé MeSH
• renin-angiotensin systém MeSH
• srdeční selhání * komplikace   farmakoterapie   MeSH
• tepový objem MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

Serum biomarkers are an important tool in the baseline risk assessment and diagnosis of cardiovascular disease in cancer patients receiving cardiotoxic cancer treatments. Increases in cardiac biomarkers including cardiac troponin and natriuretic peptides can be used to guide initiation of cardioprotective treatments for cancer patients during treatment and to monitor the response to cardioprotective treatments, and they also offer prognostic value. This position statement examines the role of cardiac biomarkers in the management of cancer patients. The Cardio-Oncology Study Group of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) in collaboration with the Cardio-Oncology Council of the ESC have evaluated the current evidence for the role of cardiovascular biomarkers in cancer patients before, during and after cardiotoxic cancer therapies. The characteristics of the main two biomarkers troponin and natriuretic peptides are discussed, the link to the mechanisms of cardiovascular toxicity, and the evidence for their clinical use in surveillance during and after anthracycline chemotherapy, trastuzumab and HER2-targeted therapies, vascular endothelial growth factor inhibitors, proteasome inhibitors, immune checkpoint inhibitors, cyclophosphamide and radiotherapy. Novel surveillance clinical pathways integrating cardiac biomarkers for cancer patients receiving anthracycline chemotherapy or trastuzumab biomarkers are presented and future direction in cardio-oncology biomarker research is discussed.

• MeSH
• antitumorózní látky * aplikace a dávkování   škodlivé účinky   MeSH
• kardiotonika aplikace a dávkování   MeSH
• kardiotoxicita * krev   diagnóza   etiologie   MeSH
• lidé MeSH
• nádorové biomarkery krev   MeSH
• nádory * krev   farmakoterapie   MeSH
• srdeční selhání * krev   chemicky indukované   diagnóza   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Research Support, N.I.H., Extramural MeSH

This position statement from the Heart Failure Association of the European Society of Cardiology Cardio-Oncology Study Group in collaboration with the International Cardio-Oncology Society presents practical, easy-to-use and evidence-based risk stratification tools for oncologists, haemato-oncologists and cardiologists to use in their clinical practice to risk stratify oncology patients prior to receiving cancer therapies known to cause heart failure or other serious cardiovascular toxicities. Baseline risk stratification proformas are presented for oncology patients prior to receiving the following cancer therapies: anthracycline chemotherapy, HER2-targeted therapies such as trastuzumab, vascular endothelial growth factor inhibitors, second and third generation multi-targeted kinase inhibitors for chronic myeloid leukaemia targeting BCR-ABL, multiple myeloma therapies (proteasome inhibitors and immunomodulatory drugs), RAF and MEK inhibitors or androgen deprivation therapies. Applying these risk stratification proformas will allow clinicians to stratify cancer patients into low, medium, high and very high risk of cardiovascular complications prior to starting treatment, with the aim of improving personalised approaches to minimise the risk of cardiovascular toxicity from cancer therapies.

• MeSH
• antagonisté androgenů škodlivé účinky   terapeutické užití   MeSH
• antitumorózní látky * škodlivé účinky   terapeutické užití   MeSH
• hodnocení rizik metody   MeSH
• kardiovaskulární nemoci * diagnóza   epidemiologie   patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory * farmakoterapie   epidemiologie   patofyziologie   MeSH
• rizikové faktory kardiovaskulárních chorob MeSH
• rizikové faktory MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Research Support, N.I.H., Extramural MeSH

BACKGROUND: Efficient trials of interventions for patients with out-of-hospital cardiac arrest (OHCA) should have adequate but not excess power to detect a difference in outcomes. The minimum clinically important difference (MCID) is the threshold value in outcomes observed in a trial at which providers should choose to adopt a treatment. There has been limited assessment of MCID for outcomes after OHCA. Therefore, we conducted an international survey of individuals interested in cardiac resuscitation to define the MCID for a range of outcomes after OHCA. METHODS: A brief survey instrument was developed and modified by consensus. Included were open-ended responses. The survey included an illustrative example of a hypothetical randomized study with distributions of outcomes based on those in a public use datafile from a previous trial. Elicited information included the minimum significant difference required in an outcome to change clinical practice. The population of interest was emergency physicians or other practitioners of acute cardiovascular research. RESULTS: Usable responses were obtained from 160 respondents (50% of surveyed) in 46 countries (79% of surveyed). MCIDs tended to increase as baseline outcomes increased. For a population of patients with 25% survival to discharge and 20% favorable neurologic status at discharge, the MCID were median 5 (interquartile range [IQR] 3, 10) percent for survival to discharge; median 5 (IQR 2, 10) percent for favorable neurologic status at discharge, median 4 (IQR 2, 9) days of ICU-free survival and median 4 (IQR 2, 8) days of hospital-free survival. CONCLUSION: Reported MCIDs for outcomes after OHCA vary according to the outcome considered as well as the baseline rate of achieving it. MCIDs of ICU-free survival or hospital-free survival may be useful to accelerate the rate of evidence-based change in resuscitation care.

• MeSH
• analýza přežití MeSH
• kardiopulmonální resuscitace * škodlivé účinky   metody   MeSH
• lidé MeSH
• mezinárodní spolupráce MeSH
• průzkumy a dotazníky MeSH
• urgentní zdravotnické služby * metody   organizace a řízení   MeSH
• výsledky intenzivní péče MeSH
• výzkum zdravotnických služeb organizace a řízení   MeSH
• zástava srdce mimo nemocnici terapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Research Support, N.I.H., Extramural MeSH