Background: older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients.Objective: to identify key barriers... Show moreBackground: older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients.Objective: to identify key barriers and to discuss solutions to specific issues affecting recruitment and retention of older participants in clinical trials based on experience gained from six current European randomised controlled trials (RCTs) focusing on older people.Methods: a multidisciplinary group of experts including representatives of the six RCTs held two networking conferences and compiled lists of potential barriers and solutions. Every item was subsequently allocated points by each study team according to how important it was perceived to be for their RCTs.Results: the six RCTs enrolled 7,612 older patients. Key barriers to recruitment were impaired health status, comorbidities and diverse health beliefs including priorities within different cultural systems. All trials had to increase the number of recruitment sites. Other measures felt to be effective included the provision of extra time, communication training for the study staff and a re-design of patient information. Key barriers for retention included the presence of severe comorbidities and the occurrence of adverse events. Long study duration, frequent study visits and difficulties accessing the study site were also mentioned. Solutions felt to be effective included spending more time maintaining close contact with the participants, appropriate measures to show appreciation and reimbursement of travel arrangements.Conclusion: recruitment and retention of older patients in trials requires special recognition and a targeted approach. Our results provide scientifically-based practical recommendations for optimizing future studies in this population. Show less
Claassens, D.M.F.; Gimbel, M.E.; Bergmeijer, T.O.; Vos, G.J.A.; Hermanides, R.S.; Harst, P. van der; ... ; Berg, J.M. ten 2021
Background: Patients with acute coronary syndrome (ACS) who are carrying CYP2C19 loss-of-function alleles derive less benefit from clopidogrel treatment. Despite this, in elderly patients,... Show moreBackground: Patients with acute coronary syndrome (ACS) who are carrying CYP2C19 loss-of-function alleles derive less benefit from clopidogrel treatment. Despite this, in elderly patients, clopidogrel might be preferred over more potent P2Y12 inhibitors due to a lower bleeding risk. Whether CYP2C19 genotype-guided antiplatelet treatment in the elderly could be of benefit has not been studied specifically.Methods: Patients aged 70 years and older with known CYP2C19*2 and *3 genotype were identified from the POPular Genetics and POPular Age trials. Noncarriers of loss-of-function alleles treated with clopidogrel were compared to patients, irrespective of CYP2C19 genotype, treated with ticagrelor and to clopidogrel treated carriers of loss-of-function alleles. We assessed net clinical benefit (all-cause death, myocardial infarction, stroke and Platelet Inhibition and Patient Outcomes (PLATO) major bleeding), atherothrombotic outcomes (cardiovascular death, myocardial infarction, stroke) and bleeding outcomes (PLATO major and minor bleeding).Results: A total of 991 patients were assessed. There was no significant difference in net clinical benefit (17.2% vs. 15.1%, adjusted hazard ratio (adjHR) 1.05, 95% confidence interval (CI) 0.77-1.44), atherothrombotic outcomes (9.7% vs. 9.2%, adjHR 1.00, 95%CI 0.66-1.50), and bleeding outcomes (17.7% vs. 19.8%, adjHR 0.80, 95%CI 0.62-1.12) between clopidogrel in noncarriers of loss-of-function alleles and ticagrelor respectively.Conclusion: In ACS patients aged 70 years and older, there was no significant difference in net clinical benefit and atherothrombotic outcomes between noncarriers of a loss-of-function allele treated with clopidogrel and pa-tients treated with ticagrelor. The bleeding rate was numerically; though not statistically significant, lower in pa-tients using clopidogrel.(c) 2021 Published by Elsevier B.V. Show less
Patients with myocardial infarction and non-obstructive coronary arteries (MINOCA), defined as angiographic stenosis <50%, represent a conundrum given the many potential underlying aetiologies.... Show morePatients with myocardial infarction and non-obstructive coronary arteries (MINOCA), defined as angiographic stenosis <50%, represent a conundrum given the many potential underlying aetiologies. Possible causes of MINOCA can be subdivided into coronary, myocardial and non-cardiac disorders. MINOCA is found in up to 14% of patients presenting with an acute coronary syndrome. Clinical outcomes including mortality, and functional and psychosocial status, are comparable to those of patients with myocardial infarction and obstructive coronary arteries. However, many uncertainties remain regarding the definition, clinical features and management of these patients. This position paper of the Dutch ACS working group of the Netherlands Society of Cardiology aims to stress the importance of considering MINOCA as a dynamic working diagnosis and to guide the clinician in the management of patients with MINOCA by proposing a clinical diagnostic algorithm. Show less
