BACKGROUND Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. METHODS This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. FINDINGS Between March 12, 2013, and May 10, 2016, we ; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). INTERPRETATION Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. FUNDING Bayer AG. Methods This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, i...

Aims Heart failure (HF) affects an estimated 38 million people worldwide and is the leading cause of hospitalization among adults and the elderly. Evidence suggests that there may be regional and ethnic differences in the prevalence, outcomes and management of HF. The aim of this study was to understand the disease burden and treatment patterns of patients hospitalized for HF in multi-ethnic Malaysia. Methods and results A retrospective, non-interventional study was conducted utilizing 10 years of medical records from the National Heart Institute Malaysia (IJN) from 1 January 2009 to 31 December 2018. Of the 4739 patients in the IJN database, 3923 were eligible and were included in this analysis. The study recorded a high male prevalence (72.3%) with a mean age of 62.0 (±13.26) years. The 30-day and 1-year rehospitalization rate was 6.8% and 24.7%, respectively. In-hospital mortality was 7.2% with 27.0% due to cardiovascular causes and 14.2% non-cardiovascular causes. The 30-day and 1-year rehospitalization rates were significantly higher in patients with lower systolic blood pressure (SBP, P < 0.001 and P = 0.002), diastolic blood pressure (DBP, P < 0.001 and P = 0.017), sodium (P < 0.001 and P = 0.029) and estimated glomerular filtration rate (eGFR, P < 0.001 and P = 0.002) and higher urea (P < 0.001 for both), serum creatinine (P < 0.001 and P = 0.003), and uric acid (P < 0.001 for both), respectively. Risk of hospitalization within 1 year varied significantly by ethnicity and was relatively higher in Indian (28.3%), followed by Malay (24.4%) and Chinese (21.9%; P = 0.008). In-hospital mortality within 1-year post-index date was higher in patients with lower weight (P = 0.002), body mass index (P = 0.009), SBP (P < 0.001), DBP (P < 0.001), sodium (P < 0.001), eGFR (P < 0.001) and higher heart rate (P = 0.039), urea (P < 0.001), serum potassium (P = 0.038), serum creatinine (P < 0.001), and uric acid (P < 0.001). In-hospital mortality within 1-year post-index date was also higher in patients with severe or end-stage chronic kidney disease (CKD) compared with mild/moderate CKD (P < 0.001) and in patients with HF with reduced ejection fraction (HFrEF) compared with those with mid-range or preserved ejection fraction (P < 0.001). The most commonly prescribed HF medications at discharge were loop diuretics (89.2%), β-blockers (68.5%), mineralocorticoid receptor antagonists (56.2%), angiotensin-converting enzyme inhibitors (31.5%), and angiotensin receptor blockers (20.8%). Conclusions This study provides a greater understanding of the characteristics, treatment patterns, and outcome of hospitalized HF patients in a leading referral centre in Malaysia and will aid the implementation of meaningful interventions to improve patient outcome for HF patients.

Background In contrast with the setting of acute myocardial infarction, there are limited data regarding the impact of diabetes mellitus on clinical outcomes in contemporary cohorts of patients with chronic coronary syndromes. We aimed to investigate the prevalence and prognostic impact of diabetes according to geographical regions and ethnicity. Methods and results CLARIFY is an observational registry of patients with chronic coronary syndromes, enrolled across 45 countries in Europe, Asia, America, Middle East, Australia, and Africa in 2009–2010, and followed up yearly for 5 years. Chronic coronary syndromes were defined by ≥1 of the following criteria: prior myocardial infarction, evidence of coronary stenosis &gt;50%, proven symptomatic myocardial ischaemia, or prior revascularization procedure. Among 32 694 patients, 9502 (29%) had diabetes, with a regional prevalence ranging from below 20% in Northern Europe to ∼60% in the Gulf countries. In a multivariable-adjusted Cox proportional hazards model, diabetes was associated with increased risks for the primary outcome (cardiovascular death, myocardial infarction, or stroke) with an adjusted hazard ratio of 1.28 (95% confidence interval 1.18, 1.39) and for all secondary outcomes (all-cause and cardiovascular mortality, myocardial infarction, stroke, heart failure, and coronary revascularization). Differences on outcomes according to geography and ethnicity were modest. Conclusion In patients with chronic coronary syndromes, diabetes is independently associated with mortality and cardiovascular events, including heart failure, which is not accounted by demographics, prior medical history, left ventricular ejection fraction, or use of secondary prevention medication. This is observed across multiple geographic regions and ethnicities, despite marked disparities in the prevalence of diabetes. ClinicalTrials identifier ISRCTN43070564

Objectives: Heart failure (HF) is a common clinical syndrome with an enormous impact on prognosis and lifestyle. Accordingly, rehabilitation measures need to be patient-specific and consider various sociocultural factors so as to improve the patient’s quality of life (QOL). This study aimed to develop and validate a HF-specific QOL (HFQOL) questionnaire within a multicultural setting. Methods: This study took place at the National Heart Institute and Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia, between March 2013 and March 2014. A self-administered 75-item HFQOL questionnaire was designed and administrated to 164 multi-ethnic Malaysian HF patients. Exploratory factor analysis was performed to assess the instrument’s construct validity. Cronbach’s alpha coefficients were used to determine internal consistency. Results: A total of 33 out of 75 items were retained in the final tool. The HFQOL questionnaire had three common factors—psychological, physical-social and spiritual wellbeing—resulting in a cumulative percentage of total variance of 44.3%. The factor loading ranges were 0.450–0.718 for psychological wellbeing (12 items), 0.394–0.740 for physical-social wellbeing (14 items) and 0.449–0.727 for spiritual wellbeing (seven items). The overall Cronbach’s alpha coefficient of the questionnaire was 0.82, with coefficients of 0.86, 0.88 and 0.79 for the psychological, physical-social and spiritual wellbeing subdomains, respectively. Conclusion: The HFQOL questionnaire was found to be a valid and reliable measure of QOL among Malaysian HF patients from various ethnic groups. Such tools may facilitate cardiac care management planning among multi-ethnic patients with HF.Keywords: Heart Failure; Quality of Life; Culturally Competent Care; Ethnic Groups; Questionnaire Design; Reliability and Validity; Malaysia.

Objective: Self-Care of Heart Failure Index (SCHFI) v6.2 Chinese is an instrument used to assess the ability of self-care behaviour among heart failure patients. It has been validated in Taiwan, however, it is yet to be validated in Malaysia. As a multi-ethnic country, Chinese language has been one of the major languages in Malaysia. Therefore, this study was conducted to examine the reliability of Self-Care of Heart Failure Index (SCHFI) v6.2 Chinese among Malaysian population. Design: A successive independent sample design was used throughout a 4-months data collection period. Setting: Eighty heart failure patients from University of Malaya Medical Centre and National Heart Institute were recruited through purposive sampling. The two hospitals were chosen because they have specialized heart clinics that eased the data collection. The out-patients were screened by the cardiologists for their eligibility to participate in this study. Measures: The samples were administered with SCHFI v6.2 Chinese. The item endorsement index, internal consistency and item-total correlation of SCHFI v6.2 Chinese were examined. Results: The maintenance subscale of SCHFI showed a low internal consistency (Cronbach α = .52) while the management and confidence subscales showed an acceptable internal consistency (Cronbach α = .67 and .90 respectively). Conclusion: SCHFI v6.2 Chinese is a reliable instrument to be used among the Malaysian population.

Background Although the burden of premature myocardial infarction (MI) is high in Malaysia, direct evidence on the determinants of MI in this multi-ethnic population remains sparse. Objective The Malaysian Acute Vascular Events Risk (MAVERIK) study is a retrospective case-control study established to investigate the genomic, lipid-related, and other determinants of acute MI in Malaysia. In this paper, we report the study protocol and early results. Methods By June 2019, we had enrolled approximately 2500 patients with their first MI and 2500 controls without cardiovascular disease, who were frequency-matched by age, sex, and ethnicity, from 17 hospitals in Malaysia. For each participant, serum and whole blood have been collected and stored. Clinical, demographic, and behavioral information has been obtained using a 200-item questionnaire. Results Tobacco consumption, a history of diabetes, hypertension, markers of visceral adiposity, indicators of lower socioeconomic status, and a family history of coronary disease were more prevalent in cases than in controls. Adjusted (age and sex) logistic regression models for traditional risk factors indicated that current smoking (odds ratio [OR] 4.11, 95% CI 3.56-4.75; P<.001), previous smoking (OR 1.34, 95% CI 1.12-1.60; P=.001), a history of high blood pressure (OR 2.13, 95% CI 1.86-2.44; P<.001), a history of diabetes mellitus (OR 2.72, 95% CI 2.34-3.17; P<.001), a family history of coronary heart disease (OR 1.28, 95% CI 1.07-1.55; P=.009), and obesity (BMI >30 kg/m2; OR 1.19, 95% CI 1.05-1.34; P=.009) were associated with MI in age- and sex-adjusted models. Conclusions The MAVERIK study can serve as a useful platform to investigate genetic and other risk factors for MI in an understudied Southeast Asian population. It should help to hasten the discovery of disease-causing pathways and inform regionally appropriate strategies that optimize public health action. International Registered Report Identifier (IRRID) RR1-10.2196/31885

UNSTRUCTURED Introduction: Although the burden of premature myocardial infarction (MI) is high in Malaysia, direct evidence on the determinants of MI in this multi-ethnic population remains sparse. The Malaysian Acute Vascular Events Risk (MAVERIK) study is a retrospective case-control study established to enable investigation of genomic, lipid-related and other determinants of acute MI in Malaysia. To our knowledge, it represents the largest case-control study of MI and related traits in Malaysia. In this paper, we report the study’s design and initial results. Methods: By June 2019, MAVERIK had enrolled about 2500 patients with first-ever MI and 2500 controls without cardiovascular disease (CVD), frequency-matched by age, sex and ethnicity, from 17 hospitals in Malaysia. For each participant, serum and whole blood have been collected and stored. Clinical, demographic and behavioural information has been obtained using a 200-item questionnaire. Results: Tobacco consumption, history of diabetes, hypertension, markers of visceral adiposity, indicators of lower socioeconomic status, and family history of coronary disease were more prevalent in cases than controls. Crude and adjusted (age, sex) logistic regression models for traditional risk factors indicated that current smoking, previous smoking, history of high blood pressure, history of diabetes mellitus, family history of CHD and obesity (BMI>30) were associated with MI in age- and sex-adjusted models. Conclusion: The MAVERIK study can serve as a useful platform to investigate genetic and other risk factors for MI in an under-studied South-East Asian population. It should help to hasten discovery of disease-causing pathways and to inform regionally appropriate strategies that optimise public health action.

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