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  1. Suhaini SA, Azidin AH, Cheah CS, Lee Wei Li W, Khoo MS, Ismail NAS, et al.
    Medicina (Kaunas), 2022 Dec 12;58(12).
    PMID: 36557034 DOI: 10.3390/medicina58121833
    Background and Objectives: Kawasaki Disease (KD) incidence has been on the rise globally throughout the years, particularly in the Asia Pacific region. KD can be diagnosed based on several clinical criteria. Due to its systemic inflammatory nature, multi-organ involvement has been observed, making the diagnosis of KD more challenging. Notably, several studies have reported KD patients presenting with hepatobiliary abnormalities. Nonetheless, comprehensive data regarding the hepatobiliary manifestations of KD are limited in Malaysia, justifying a more in-depth study of the disease in this country. Thus, in this article, we aim to discuss KD patients in Malaysia with hepatobiliary manifestations. Materials and Methods: A total of six KD patients with hepatobiliary findings who presented at Hospital Canselor Tuanku Muhriz (HCTM) from 2004 to 2021 were selected and included. Variables including the initial presenting signs and symptoms, clinical progress, laboratory investigations such as liver function test (LFT), and ultrasound findings of hepatobiliary system were reviewed and analyzed. Results: Out of these six KD patients, there were two patients complicated with hepatitis and one patient with gallbladder hydrops. Different clinical features including jaundice (n = 3) and hepatomegaly (n = 4) were also observed. All patients received both aspirin and intravenous immunoglobulin (IVIG) as their first-line treatment and all of them responded well to IVIG. The majority of them (n = 5) had a complete recovery and did not have any cardiovascular and hepatobiliary sequelae. Conclusions: Despite KD mostly being diagnosed with the classical clinical criteria, patients with atypical presentations should always alert physicians of KD as one of the possible differential diagnoses. This study discovered that hepatobiliary manifestations in KD patients were not uncommon. More awareness on the epidemiology, diagnosis, and management of KD patients with hepatobiliary manifestations are required to allow for the initiation of prompt treatment, thus preventing further complications.
    Matched MeSH terms: Aspirin/therapeutic use
  2. Krishnan K, Law ZK, Minhas JS, Bath PM, Robinson TG, Sprigg N, et al.
    Clin Med (Lond), 2022 Sep;22(5):449-454.
    PMID: 36507812 DOI: 10.7861/clinmed.2021-0597
    Acute stroke is the leading cause of disability in the UK and a leading cause of mortality worldwide. The majority of patients with ischaemic stroke present with minor deficits or transient ischaemic attack (TIA), and are often first seen by patient-facing clinicians. Urgent evaluation and treatment are important as many patients are at high risk of major vascular events and death within hours to days after the index event. This narrative review summarises the evidence on four antiplatelet treatments for non-cardioembolic stroke prevention: aspirin, clopidogrel, dipyridamole and ticagrelor. Each of these drugs has a unique mechanism and has been tested as a single agent or in combination. Aspirin, when given early is beneficial and short-term treatment with aspirin and clopidogrel has been shown to be more effective in high-risk TIA / minor stroke. This review concludes by highlighting gaps in evidence, including scope for future trials that could potentially change clinical practice.
    Matched MeSH terms: Aspirin/therapeutic use
  3. Malik AS
    Ann Trop Paediatr, 1996 Sep;16(3):213-20.
    PMID: 8893951 DOI: 10.1080/02724936.1996.11747829
    We report seven cases of Kawasaki disease (KD) who were admitted to Hospital University Sains Malaysia over a period of 8 years. The average age at the time of admission was 29.4 months and four of the children were boys. Five children had all six criteria for diagnosis. Ileus was present in three, and hydrops of the gall bladder and pneumonia in two each, but coronary artery dilatation was seen in only one patient. We also review all the cases of KD reported so far from Malaysia and compare the epidemiological data, clinical course and laboratory findings of the Malaysian patients with those from other parts of the world. The epidemiological and clinical features of Malaysians with KD differ from those seen in Singapore and Japan, but are similar to those seen in Thailand, Australia and North America. The incidence of cardiac complications is low in Malaysians.
    Matched MeSH terms: Aspirin/therapeutic use
  4. Gururaj AK, Chand RP, Chuah SP
    Clin Neurol Neurosurg, 1988;90(3):261-3.
    PMID: 3197355
    Cerebral involvement associated with juvenile rheumatoid arthritis is rare. It is not influenced by treatment and the presentation can be varied. We describe a case of cerebral infarction secondary to vasculitis in a child with juvenile rheumatoid arthritis.
    Matched MeSH terms: Aspirin/therapeutic use
  5. Med J Malaysia, 1988 Sep;43(3):267-8.
    PMID: 3241590
    Reproduced from Quarterly Review, National Dairy Council Nutrition Services, London (NIS/9/88)
    Matched MeSH terms: Aspirin/therapeutic use*
  6. Irfan M, Ismail SB, Noor NM, Hussain NHN
    Am J Mens Health, 2020 10 29;14(5):1557988320969082.
    PMID: 33111628 DOI: 10.1177/1557988320969082
    One of the major causes of erectile dysfunction (ED) is an endothelial vascular disorder. This meta-analysis is performed to determine the efficacy of aspirin on erectile function in men with vasculogenic ED. For this purpose, CENTRAL, MEDLINE, and reference lists of articles up to November 2019 were searched. Randomized controlled trials (RCTs) were selected that compared aspirin with placebo in men of any ethnicity with vasculogenic ED. A total of 58 trials were retrieved. Finally, two trials of 214 men fulfilled our selection criteria. High selection and detection bias were identified for one trial. The participants showed a significant improvement in erectile function when they took aspirin (mean difference: 5.14, 95% CI [3.89, 6.40], and I2 = 0%). Although the present meta-analysis suggested that aspirin has a significant effect on the improvement of erectile function, there were limited RCTs available on this topic and doses of aspirin varied. Additional studies are needed to support findings from this meta-analysis. Aspirin needs to be considered by practitioners when prescribing drugs for vasculogenic ED.
    Matched MeSH terms: Aspirin/therapeutic use*
  7. Tan HJ, Mahadeva S, Menon J, Ng WK, Zainal Abidin I, Chan FK, et al.
    J Dig Dis, 2013 Jan;14(1):1-10.
    PMID: 23134105 DOI: 10.1111/1751-2980.12000
    The working party statements aim to provide evidence and guidelines to practising doctors on the use of antiplatelet therapy and proton pump inhibitors (PPIs) in patients with cardiovascular risk as well as those at risk of gastrointestinal (GI) bleeding. Balancing the GI and cardiovascular risk and benefits of antiplatelet therapy and PPIs may sometimes pose a significant challenge to doctors. Concomitant use of anti-secretory medications has been shown to reduce the risk of GI bleeding but concerns have been raised on the potential interaction of PPIs and clopidogrel. Many new data have emerged on this topic but some can be confusing and at times controversial. These statements examined the supporting evidence in four main areas: rationale for antiplatelet therapy, risk factors of GI bleeding, PPI-clopidogrel interactions and timing for recommencing antiplatelet therapy after GI bleeding, and made appropriate recommendations.
    Matched MeSH terms: Aspirin/therapeutic use
  8. Norlinah MI, Shahizon AM
    Med J Malaysia, 2008 Dec;63(5):410-2.
    PMID: 19803303 MyJurnal
    Secondary paroxysmal dyskinesias (PxD) have been previously reported in patients with multiple sclerosis, lacunar infarcts, head trauma, metabolic disorders such as hyperglycaemia, hypocalcaemia, migraine and central nervous system (CNS) infections. The causative lesions typically involve the basal ganglia structures, medulla and rarely the spinal cord. We report two patients who presented with paroxysmal dyskinesias as the only manifestation of subcortical white-matter ischaemia. Patient 1 presented with 3-year history of paroxysmal kinesigenic dyskinesia (PKD) and patient 2 with 6-month history of paroxysmal nonkinesigenic dyskinesia (PNKD). All investigations, including CSF oligoclonal bands were negative, except for a brain MRI which showed multiple, non-enhancing subcortical white matter lacunar infarcts. Therefore, subcortical white matter ischaemia should also be included in the differential diagnosis of PxD.
    Matched MeSH terms: Aspirin/therapeutic use
  9. Viecelli AK, Polkinghorne KR, Pascoe EM, Paul-Brent PA, Hawley CM, Badve SV, et al.
    PLoS One, 2019;14(3):e0213274.
    PMID: 30913208 DOI: 10.1371/journal.pone.0213274
    BACKGROUND: Arteriovenous fistulas (AVF) for haemodialysis often experience early thrombosis and maturation failure requiring intervention and/or central venous catheter (CVC) placement. This secondary and exploratory analysis of the FAVOURED study determined whether omega-3 fatty acids (fish oils) or aspirin affected AVF usability, intervention rates and CVC requirements.

    METHODS: In 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting one day pre-surgery and continued for three months. Outcomes evaluated within 12 months included AVF intervention rates, CVC exposure, late dialysis suitability failure, and times to primary patency loss, abandonment and successful cannulation.

    RESULTS: Final analyses included 536 participants randomised to fish oil or placebo (mean age 55 years, 64% male, 45% diabetic) and 388 randomised to aspirin or placebo. Compared with placebo, fish oil reduced intervention rates (0.82 vs 1.14/1000 patient-days, incidence rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54-0.97), particularly interventions for acute thrombosis (0.09 vs 0.17/1000 patient-days, IRR 0.53, 95% CI 0.34-0.84). Aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27-0.78). Neither agent significantly affected CVC exposure, late dialysis suitability failure or time to primary patency loss, AVF abandonment or successful cannulation.

    CONCLUSION: Although fish oil and low-dose aspirin given for 3 months reduced intervention rates in newly created AVF, they had no significant effects on CVC exposure, AVF usability and time to primary patency loss or access abandonment. Reduction in access interventions benefits patients, reduces costs and warrants further study.

    Matched MeSH terms: Aspirin/therapeutic use*
  10. Jalil NJ, Bannur Z, Derahman A, Maskon O, Darinah N, Hamidi H, et al.
    J Pharm Pharm Sci, 2015;18(3):474-83.
    PMID: 26517138
    PURPOSE:   Enzymes potentially responsible for the pharmacokinetic variations of aspirin include cyclooxygenase-1 (COX-1), UDP-glucuronosyltransferase (UGT1A6) and P450 (CYP) (CYP2C9). We therefore aimed to determine the types and frequencies of variants of COX-1 (A-842G), UGT1A6 (UGT1A6*2; A541G and UGT1A6*3; A522C) and CYP2C9 (CYP2C9*3; A1075C) in the three major ethnic groups in Malaysia. In addition, the role of these polymorphisms on aspirin-induced gastritis among the patients was investigated.

    METHODS: A total of 165 patients with cardiovascular disease who were treated with 75-150 mg daily dose of aspirin and 300 healthy volunteers were recruited. DNA was extracted from the blood samples and genotyped for COX-1 (A-842G), UGT1A6 (UGT1A6*2 and UGT1A6*3) and CYP2C9 (CYP2C9*3; A1075C) using allele specific polymerase chain reaction (AS-PCR).

    RESULTS: Variants UGT1A6*2,*3 and CYP2C9*3 were detected in relatively high percentage of 22.83%, 30.0% and 6.50%, respectively; while COX-1 (A-842G) was absent. The genotype frequencies for UGT1A6*2 and *3 were significantly different between Indians and Malays or Chinese. The level of bilirubin among patients with different genotypes of UGT1A6 was significantly different (p-value < 0.05). In addition, CYP2C9*3 was found to be associated with gastritis with an odd ratio of 6.8 (95 % Cl OR: 1.39 - 33.19; P = 0.033).

    CONCLUSION: Screening of patients with defective genetic variants of UGT1A6 and CYP2C9*3 helps in identifying patients at risk of aspirin induced gastritis. However, a randomised clinical study of bigger sample size would be needed before it is translated to clinical use.

    Matched MeSH terms: Aspirin/therapeutic use*
  11. Lee CY, Liu KT, Lu HT, Mohd Ali R, Fong AYY, Wan Ahmad WA
    PLoS One, 2021;16(2):e0246474.
    PMID: 33556136 DOI: 10.1371/journal.pone.0246474
    BACKGROUND: Sex and gender differences in acute coronary syndrome (ACS) have been well studied in the western population. However, limited studies have examined the trends of these differences in a multi-ethnic Asian population.

    OBJECTIVES: To study the trends in sex and gender differences in ACS using the Malaysian NCVD-ACS Registry.

    METHODS: Data from 24 hospitals involving 35,232 ACS patients (79.44% men and 20.56% women) from 1st. Jan 2012 to 31st. Dec 2016 were analysed. Data were collected on demographic characteristics, coronary risk factors, anthropometrics, treatments and outcomes. Analyses were done for ACS as a whole and separately for ST-segment elevation myocardial infarction (STEMI), Non-STEMI and unstable angina. These were then compared to published data from March 2006 to February 2010 which included 13,591 ACS patients (75.8% men and 24.2% women).

    RESULTS: Women were older and more likely to have diabetes mellitus, hypertension, dyslipidemia, previous heart failure and renal failure than men. Women remained less likely to receive aspirin, beta-blocker, angiotensin-converting enzyme inhibitor (ACE-I) and statin. Women were less likely to undergo angiography and percutaneous coronary intervention (PCI) despite an overall increase. In the STEMI cohort, despite a marked increase in presentation with Killip class IV, women were less likely to received primary PCI or fibrinolysis and had longer median door-to-needle and door-to-balloon time compared to men, although these had improved. Women had higher unadjusted in-hospital, 30-Day and 1-year mortality rates compared to men for the STEMI and NSTEMI cohorts. After multivariate adjustments, 1-year mortality remained significantly higher for women with STEMI (adjusted OR: 1.31 (1.09-1.57), p<0.003) but were no longer significant for NSTEMI cohort.

    CONCLUSION: Women continued to have longer system delays, receive less aggressive pharmacotherapies and invasive treatments with poorer outcome. There is an urgent need for increased effort from all stakeholders if we are to narrow this gap.

    Matched MeSH terms: Aspirin/therapeutic use
  12. Irish AB, Viecelli AK, Hawley CM, Hooi LS, Pascoe EM, Paul-Brent PA, et al.
    JAMA Intern Med, 2017 02 01;177(2):184-193.
    PMID: 28055065 DOI: 10.1001/jamainternmed.2016.8029
    Importance: Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure.

    Objective: To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure.

    Design, Setting, and Participants: The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation.

    Interventions: Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks.

    Main Outcomes and Measures: The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome.

    Results: Of 1415 eligible participants, 567 were randomized (359 [63%] male, 298 [53%] white, 264 [47%] with diabetes; mean [SD] age, 54.8 [14.3] y). The same proportion of fistula failures occurred in the fish oil and placebo arms (128 of 270 [47%] vs 125 of 266 [47%]; relative risk [RR] adjusted for aspirin use, 1.03; 95% CI, 0.86-1.23; P = .78). Fish oil did not reduce fistula thrombosis (60 [22%] vs 61 [23%]; RR, 0.98; 95% CI, 0.72-1.34; P = .90), abandonment (51 [19%] vs 58 [22%]; RR, 0.87; 95% CI, 0.62-1.22; P = .43), or cannulation failure (108 [40%] vs 104 [39%]; RR, 1.03; 95% CI, 0.83-1.26; P = .81). The risk of fistula failure was similar between the aspirin and placebo arms (87 of 194 [45%] vs 83 of 194 [43%]; RR, 1.05; 95% CI, 0.84-1.31; P = .68).

    Conclusions and Relevance: Neither fish oil supplementation nor aspirin use reduced failure of new arteriovenous fistulae within 12 months of surgery.

    Trial Registration: anzctr.org.au Identifier: CTRN12607000569404.

    Matched MeSH terms: Aspirin/therapeutic use*
  13. Ahmad A, Patel I, Asani H, Jagadeesan M, Parimalakrishnan S, Selvamuthukumaran S
    Indian J Pharmacol, 2015 Jan-Feb;47(1):90-4.
    PMID: 25821318 DOI: 10.4103/0253-7613.150360
    Antithrombotic therapy with heparin plus antiplatelets reduces the rate of ischemic events in patients with coronary heart disease. Low molecular weight heparin has a more predictable anticoagulant effect than standard unfractionated heparin, is easier to administer, does not require monitoring and is associated with less ADRs. The purpose of the present study was to evaluate and compare the clinical and cost outcomes of Enoxaparin with a standard unfractionated heparin in patients with coronary heart disease.
    Matched MeSH terms: Aspirin/therapeutic use
  14. Soon SS, Chia WK, Chan ML, Ho GF, Jian X, Deng YH, et al.
    PLoS One, 2014;9(9):e107866.
    PMID: 25250815 DOI: 10.1371/journal.pone.0107866
    Recent observational studies showed that post-operative aspirin use reduces cancer relapse and death in the earliest stages of colorectal cancer. We sought to evaluate the cost-effectiveness of aspirin as an adjuvant therapy in Stage I and II colorectal cancer patients aged 65 years and older.
    Matched MeSH terms: Aspirin/therapeutic use*
  15. Woolley AK, Hedger NA, Veettil RP
    Acute Med, 2013;12(2):107-10.
    PMID: 23732136
    Pyrexia of unknown origin (PUO) is a frequent presentation to the Acute Medical Unit, and is a source of significant morbidity, both the psychological burden of an uncertain diagnosis and prognosis and untreated complications of the underlying pathology. We present a problem based review of the management of PUO, illustrated by a patient who recently presented to our unit with fever and systemic malaise after returning from abroad and in whom no cause could be found for more than two months. We describe a structured approach making use of complex modern techniques such as Positron Emission Tomography-Computed Tomography (PET-CT) which ultimately provided the diagnosis for our patient.
    Matched MeSH terms: Aspirin/therapeutic use
  16. Viecelli AK, Pascoe E, Polkinghorne KR, Hawley C, Paul-Brent PA, Badve SV, et al.
    BMC Nephrol, 2015;16:89.
    PMID: 26116581 DOI: 10.1186/s12882-015-0089-2
    The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design.
    Matched MeSH terms: Aspirin/therapeutic use*
  17. Venkatason P, Zubairi YZ, Wan Ahmad WA, Hafidz MI, Ismail MD, Hadi MF, et al.
    BMJ Open, 2019 05 05;9(5):e025734.
    PMID: 31061031 DOI: 10.1136/bmjopen-2018-025734
    OBJECTIVES: Cardiogenic shock (CS) complicating ST-elevation myocardial infarction (STEMI) carries an extremely high mortality. The clinical pattern of this life threatening complication has never been described in Malaysian setting. This study is to investigate the incidence, clinical characteristics and outcome of STEMI patients with CS in our population.

    DESIGN: A retrospective analysis of STEMI patients from 18 hospitals across Malaysia contributing to the Malaysian National Cardiovascular Database-acute coronary syndrome) registry (NCVD-ACS) year 2006-2013.

    PARTICIPANTS: 16 517 patients diagnosed of STEMI from 18 hospitals in Malaysia from the year 2006 to 2013.

    PRIMARY OUTCOME MEASURES: In-hospital and 30 day post-discharge mortality.

    RESULTS: CS complicates 10.6% of all STEMIs in this study. They had unfavourable premorbid conditions and poor outcomes. The in-hospital mortality rate was 34.1% which translates into a 7.14 times mortality risk increment compared with STEMI without CS. Intravenous thrombolysis remained as the main urgent reperfusion modality. Percutaneous coronary interventions (PCI) in CS conferred a 40% risk reduction over non-invasive therapy but were only done in 33.6% of cases. Age over 65, diabetes mellitus, hypertension, chronic lung and kidney disease conferred higher risk of mortality.

    CONCLUSION: Mortality rates of CS complicating STEMI in Malaysia are high. In-hospital PCI confers a 40% mortality risk reduction but the rate of PCI among our patients with CS complicating STEMI is still low. Efforts are being made to increase access to invasive therapy for these patients.

    Matched MeSH terms: Aspirin/therapeutic use
  18. Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, et al.
    N Engl J Med, 2021 01 21;384(3):216-228.
    PMID: 33186492 DOI: 10.1056/NEJMoa2028220
    BACKGROUND: A polypill comprising statins, multiple blood-pressure-lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease.

    METHODS: Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed.

    RESULTS: A total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.

    CONCLUSIONS: Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437.).

    Matched MeSH terms: Aspirin/therapeutic use*
  19. Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, et al.
    N Engl J Med, 2017 10 05;377(14):1319-1330.
    PMID: 28844192 DOI: 10.1056/NEJMoa1709118
    BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention.

    METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.

    RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.

    CONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).

    Matched MeSH terms: Aspirin/therapeutic use*
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