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    Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial
    (Elsevier BV, 2018-01)
    Stuart J Connolly
    ;
    John W Eikelboom
    ;
    Jackie Bosch
    ;
    Gilles Dagenais
    ;
    Leanne Dyal
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    Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
    (Massachusetts Medical Society, 2017-10-05)
    John W. Eikelboom
    ;
    Stuart J. Connolly
    ;
    Jackie Bosch
    ;
    Gilles R. Dagenais
    ;
    Robert G. Hart
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    The Aldosterone Blockade for Health Improvement Evaluation in End-Stage Renal Disease (ACHIEVE) Trial: Rationale and Clinical Research Protocol
    (SAGE Publications, 2025-06)
    Michael Walsh
    ;
    David Collister
    ;
    Martin Gallagher
    ;
    Patrick B. Mark
    ;
    Janak R. de Zoysa
    Background: The mineralocorticoid aldosterone may contribute to the risk of cardiovascular morbidity and mortality in patients receiving maintenance dialysis. Whether spironolactone, a mineralocorticoid receptor antagonist, improves outcomes for patients receiving maintenance dialysis is unclear. Objective: To assess the efficacy and safety of spironolactone in patients receiving maintenance dialysis. Design: Placebo-controlled, randomized controlled trial. Setting: Dialysis units Patients: Patients receiving maintenance dialysis who are adherent to and able to tolerate spironolactone 25 mg daily during an open-label run-in period of at least 49 days were randomized to spironolactone 25 mg daily or matching placebo. Measurements: Randomized participants were followed for the primary outcome of cardiovascular death or hospitalization due to heart failure. Secondary outcomes include cause specific deaths, hospitalization due to heart failure, all-cause death, all-cause hospitalizations, and severe hyperkalemia. All deaths and possible hospitalizations for heart failure were adjudicated. Methods: Eligible participants received open-label spironolactone 25 mg daily for at least 7 weeks during a run-in period. Participants who tolerated and adhered to treatment were randomly allocated to continue spironolactone 25 mg daily or a matching placebo. We followed participants until trial close. Results: The trial began recruitment in 2018 and concluded recruitment in December 2024. Despite a reduced rate of recruitment during the global COVID-19 pandemic 3565 eligible participants were enrolled of whom 2538 were randomized to spironolactone or placebo from 143 dialysis programs. Limitations: Limited funding and the trial was stopped early due to futility to demonstrate an effect. Conclusions: ACHIEVE was designed as a large, simple trial to determine if spironolactone 25 mg daily prevents cardiovascular mortality and heart failure hospitalizations in patients with kidney failure receiving maintenance dialysis. ACHIEVE demonstrates the possibility of conducting large, international, investigator initiated randomized controlled trials for patients with kidney failure receiving dialysis.
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    The burden of cardiovascular events according to cardiovascular risk profile in adults from high-income, middle-income, and low-income countries - PURE: a cohort study
    (Elsevier BV, 2025-08)
    Darryl P Leong
    ;
    Rita Yusuf
    ;
    Romaina Iqbal
    ;
    Alvaro Avezum
    ;
    Afzalhussein Yusufali
    Background: Current strategies to prevent adverse cardiovascular outcomes focus primary prevention in high-risk groups and secondary prevention in people with known cardiovascular disease. We aimed to determine the proportion of events occurring in lower-risk groups globally. Methods: We included people aged 40 years to younger than 75 years who were enrolled in the Prospective Urban Rural Epidemiology (PURE) study, which is an ongoing, international, prospective, population-based cohort study that started recruiting adults from households selected to be broadly representative of the sociodemographic composition of their communities. We prospectively documented fatal or non-fatal myocardial infarction, stroke, heart failure, or any other fatal cardiovascular event stratified by history of cardiovascular disease and by the 10-year predicted disease risk scores based on WHO 2019 laboratory risk tables (<10% [low], 10% to <20% [intermediate], and ≥20% [high]) in people without previous cardiovascular disease from 26 high-income, middle-income, and low-income countries. Outcome event rates were standardised for the cohort's age and sex distribution. Findings: Between July 11, 2000, and May 6, 2019, 128 973 participants were included from 26 countries (mean age 53·6 years [SD 8·2]; 75 858 [58·8%] were female and 53 115 [41·2%] were male). We observed 11 483 outcome events affecting 8·9% of the cohort during a median follow-up of 12·3 years (IQR 9·8–14·6). Among participants, 89 508 (69·4%) had a low cardiovascular disease risk, 22 363 (17·3%) had an intermediate cardiovascular disease risk, and 5529 (4·3%) had a high cardiovascular disease risk, while 11 573 (9·0%) had known cardiovascular disease. The age-standardised and sex-standardised cardiovascular disease incidence rates per 1000 person-years was 4·1 (95% CI 4·0–4·2) in the low-risk group, 17·7 (15·2–20·2) in the intermediate-risk group, and 40·8 (25·1–56·4) in the high-risk group. Overall, 41% of outcome events occurred in cardiovascular disease-naive participants at low risk. The proportion of adverse cardiovascular outcomes occurring in this low-risk group was inversely related to country income level (32% in high-income, 38% in middle-income, and 54% in low-income countries) and was higher in women (51%) than in men (32%). Interpretation: To achieve a substantial population-level reduction in cardiovascular disease, a fundamental change is needed, so that preventive strategies for cardiovascular disease extend beyond those at high or even intermediate predicted risk to include those at considered to be at low risk. Funding: The funding bodies are listed in the appendix (p 29).
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    Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease
    (Elsevier BV, 2021-07)
    John W. Eikelboom
    ;
    Deepak L. Bhatt
    ;
    Keith A.A. Fox
    ;
    Jacqueline Bosch
    ;
    Stuart J. Connolly
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    Self-Reported Prevalence of Chronic Non-Communicable Diseases Concerning Socioeconomic and Educational Factors: Analysis of the PURE-Ecuador Cohort
    (Ubiquity Press, Ltd., 2025-03-13) ; ;
    Michelle Vega
    ;
    Katherine Andrango
    ;
    Selena Andrango
    Background: The changing epidemiological landscape, marked by the increasing prominence of Non-Communicable Chronic Diseases (NCDs), underscores the need for studies that identify and analyze these conditions and their associated risk factors. This secondary analysis aims to describe the association between socioeconomic and educational characteristics and the prevalence of self-reported NCDs among participants in the PURE-Ecuador cohort in urban and rural populations of the Metropolitan District of Quito (MDQ), Ecuador. Methods: This secondary analysis is part of the Prospective Urban Rural Epidemiological (PURE) study. Data were collected from February to December 2018, including 2028 participants aged 35 to 70 years from different urban and rural areas of the MDQ. Data collection utilized standardized questionnaires administered in face-to-face interviews. Pearson’s chi-square tests and multivariate logistic regression were used to assess associations. Results: The self-reported prevalence of hypertension was 16.2%, rising to 32.7% in individuals over 60 years old. The prevalence of diabetes mellitus was 6.7%, coronary heart disease 1.3%, stroke 1.6%, heart failure 1.3%, COPD 0.4%, asthma 1.3%, and cancer 1.9%. Multimorbidity affected 5.9% of participants, with the highest rates in obese and older individuals (≥60 years). Adherence to medications was high for hypertension and diabetes mellitus but varied substantially between communities. Conclusions: The secondary analysis revealed significant disparities in the prevalence and management of NCDs in MDQ. The prevalence of self-reported NCDs in Quito, Ecuador, is significantly associated with age and body mass index (BMI). Older individuals, particularly those over 60 years, and obese participants demonstrated higher rates of NCDs and multimorbidity. While socioeconomic factors such as education and income showed some associations with NCD prevalence, these were less pronounced after adjusting for other variables. These findings highlight the importance of age-specific and obesity-focused interventions in addressing the burden of NCDs in this population.
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    Colchicine and the combination of rivaroxaban and aspirin in patients hospitalised with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial
    (Elsevier BV, 2022-12)
    John W Eikelboom
    ;
    Sanjit S Jolly
    ;
    Emilie P Belley-Cote
    ;
    Richard P Whitlock
    ;
    Sumathy Rangarajan
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    Low levels of awareness, treatment, and control of hypertension in Andean communities of Ecuador
    (Wiley, 2020-08-15) ;
    Manuel E. Baldeon
    ;
    Federico Zertuche
    ;
    Marco Fornasini
    ;
    Maria Jose Paucar
    <jats:title>Abstract</jats:title><jats:p>The major burden of hypertension (HTN) occurs in low‐middle‐income countries (LMIC) and it is the main modifiable risk factor for cardiovascular diseases (CVD). Few population studies on HTN prevalence have been carried out in Ecuador where there is limited information regarding its prevalence, awareness, treatment, and control. Thus, the aim of the present study was to determine the prevalence, awareness, treatment, and control of HTN and its association with socio‐economic, nutritional, and lifestyle habits in urban and rural Andean communities of Pichincha province in Ecuador. The authors studied 2020 individuals aged 35‐70 years (mean age 50.8 years, 72% women), included in the Ecuadorian cohort of the Prospective Urban and Rural Epidemiology (PURE) study, from February to December 2018. The hypertension prevalence (&gt;140/90 mmHg) was 27% and was greater in urban than in rural communities, more common in men, in individuals older than 50 years of age, in people with low monthly income and low level of education. Higher prevalence was also observed in subjects with obesity, and among former smokers and those who consumed alcohol. Only 49% of those with HTN were aware of their condition, 40% were using antihypertensive medications, and 19% had their blood pressure under control (&lt;140/90 mmHg). These results showed low levels of awareness, treatment, and control of HTN in the Andean region of Ecuador, suggesting the urgent necessity of implementing programs to improve the diagnosis and management of HTN.</jats:p>
    Scopus© Citations 10
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    Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin
    (Elsevier BV, 2019-09)
    Paul Moayyedi
    ;
    John W. Eikelboom
    ;
    Jackie Bosch
    ;
    Stuart J. Connolly
    ;
    Leanne Dyal
    Scopus© Citations 455