Publications by authors named "Mark Effron"

Background: A previous single-center study of patients with myocardial infarction (MI) showed that platelet FcγRIIa (pFCG) can distinguish patients at higher and lower risk of subsequent MI, stroke, and death.

Objectives: The authors performed an 800-patient 25-center study to validate the prognostic implications of pFCG.

Methods: Patients with type 1 MI (ST-segment elevation and non-ST-segment elevation) were enrolled in a prospective noninterventional trial during their index hospitalization.

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  • The study aimed to assess the effectiveness and safety of low (81 mg) versus high-dose (325 mg) aspirin in patients with established atherosclerotic cardiovascular disease (ASCVD) across different racial groups.
  • Conducted as a secondary analysis of the ADAPTABLE trial, the research involved over 14,000 participants from various racial backgrounds and compared their responses to different aspirin doses over a median follow-up of 26.2 months.
  • The results indicated that race did not significantly alter the effectiveness or safety of aspirin dosing, suggesting that all racial groups responded similarly to the treatment.
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  • The study investigates how different data sources (like electronic health records, insurance claims, and participant reports) contribute to analyzing clinical outcomes in a pragmatic randomized clinical trial (RCT) involving patients with atherosclerotic cardiovascular disease.
  • Conducted from April 2016 to June 2019, the ADAPTABLE study looked at the effects of daily aspirin doses on certain health events, while comparing participant data availability to enhance understanding of outcome rates.
  • The findings revealed a predominance of participant-reported and EHR data, with only a small percentage relying solely on claims data, indicating the need for further study on the varying contributions of each data source to overall clinical results.
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  • - Atherosclerotic cardiovascular disease (ASCVD) is the main health issue in the US, and while aspirin is commonly used for its prevention, a trial (ADAPTABLE) found no significant difference in outcomes between 81 mg and 325 mg doses of aspirin.
  • - The study aimed to investigate whether there are differences in safety and effectiveness of the two aspirin doses based on sex, as previous findings didn't address this.
  • - Conducted across multiple medical centers, the ADAPTABLE trial involved over 15,000 participants with established ASCVD, analyzing outcomes related to major bleeding, heart attacks, and strokes, with a focus on comparing male and female responses to the aspirin doses.
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Background: Reflecting clinical trial data showing improved outcomes with lower LDL-C levels, guidelines across the globe are increasingly recommending a goal of LDL-C <55 mg/dL in persons with atherosclerotic cardiovascular disease (ASCVD). What proportion of patients with ASCVD are already meeting those goals in the US remains understudied.

Methods: Using electronic health record data from 8 large US health systems, we evaluated lipid-lowering therapy (LLT), LDL-C levels, and factors associated with an LDL-C <55 mg/dL in persons with ASCVD treated between 1/1/2021-12/31/2021.

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  • In patients with atherosclerotic cardiovascular disease, increased age is linked to higher risks of both ischemic and bleeding events, prompting a study on the effect of aspirin dosage based on age.
  • The ADAPTABLE trial involved nearly 15,100 participants who were randomly assigned to take either 81 mg or 325 mg of aspirin daily, with outcomes measured over an average follow-up of 26.2 months.
  • Results indicated that age did not significantly affect how aspirin dosage influenced clinical outcomes, suggesting that both doses are similarly effective for elderly and younger patients in preventing cardiovascular events.
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  • The ADAPTABLE trial, a large study on aspirin dosing for preventing heart issues, showed no significant difference in efficacy between high- and low-dose aspirin in patients with cardiovascular disease.
  • It explored whether using P2Y12 inhibitors like clopidogrel or prasugrel impacted aspirin's effectiveness or safety; however, results indicated no interaction between aspirin dose and P2Y12 inhibitor use.
  • Participants taking P2Y12 inhibitors had a higher risk of major cardiovascular events but not an increased risk of bleeding, and switching doses was more common in the high-dose group without being influenced by P2Y12 inhibitor status.
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  • Clinicians recommend enteric-coated aspirin to reduce gastrointestinal bleeding for patients with coronary artery disease, despite evidence suggesting it may be less effective at inhibiting platelets than uncoated aspirin.
  • This study analyzed data from the ADAPTABLE trial, which involved over 15,000 patients with atherosclerotic cardiovascular disease, to compare the effectiveness and safety of enteric-coated versus uncoated aspirin.
  • The primary outcomes measured were the occurrence of major cardiovascular events and major bleeding incidents, with findings indicating the differences in these outcomes between the two aspirin formulations over approximately 26 months of follow-up.
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  • Patients with diabetes mellitus (DM) and atherosclerotic cardiovascular disease (ASCVD) were studied to determine the impact of different aspirin doses on cardiovascular risks and bleeding events.* -
  • The research involved 15,076 patients, revealing that those with DM had higher rates of cardiovascular issues and bleeding compared to those without DM, regardless of whether they took 81 mg or 325 mg of aspirin.* -
  • The results indicate that increasing the dose of aspirin does not provide additional benefits for patients with DM, highlighting their increased risk in general rather than a response to medication.*
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Background: Apparent treatment-resistant hypertension (aTRH) is defined as uncontrolled blood pressure (BP) despite using ≥3 antihypertensive classes or controlled BP while using ≥4 antihypertensive classes. Patients with aTRH have a higher risk for adverse cardiovascular outcomes compared with patients with controlled hypertension (HTN). Although there have been prior reports on the prevalence, characteristics, and predictors of aTRH, these have been broadly derived from smaller datasets, randomized controlled trials, or closed healthcare systems.

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Aims: Based on recent clinical data, the 2020 ESC guidelines on non-ST-elevation acute coronary syndrome (NSTE-ACS) suggest to tailor antithrombotic strategy on individual thrombotic risk. Nonetheless, prevalence and prognostic impact of the high thrombotic risk (HTR) criteria proposed are yet to be described. In this analysis from the PROMETHEUS registry, we assessed prevalence and prognostic impact of HTR, defined according to the 2020 ESC NSTE-ACS guidelines, and if the benefits associated with prasugrel vs.

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Background: Thrombo-inflammation is central to COVID-19-associated coagulopathy. TF (tissue factor), a driver of disordered coagulation and inflammation in viral infections, may be a therapeutic target in COVID-19. The safety and efficacy of the novel TF inhibitor rNAPc2 (recombinant nematode anticoagulation protein c2) in COVID-19 are unknown.

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  • Internet-based participation in clinical trials can improve diversity and relevance, but there are key differences between internet and noninternet participants, particularly in demographics and health status.
  • In the ADAPTABLE study, noninternet participants were generally older, more likely to be female, and had higher rates of comorbid conditions, resulting in poorer health outcomes compared to internet participants.
  • Noninternet participants also exhibited greater issues with medication adherence, suggesting that while noninternet options can enhance diversity in trials, strategies are needed to improve their retention and adherence rates.
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  • - The ADAPTABLE trial examined the effects of different doses of aspirin (81 mg vs 325 mg daily) on cardiovascular events and bleeding rates in patients with existing cardiovascular disease, finding no significant differences between the two doses.
  • - In a secondary analysis focusing on patients with chronic kidney disease (CKD), results showed that CKD patients had a higher risk of adverse cardiovascular outcomes and major bleeding, regardless of the aspirin dose they were taking.
  • - The study concluded that while CKD increased the risk for complications, the dosing of aspirin did not affect the risk of adverse events or bleeding in these patients.
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Background: Apparent treatment-resistant hypertension (aTRH) is defined as uncontrolled blood pressure (BP) despite using ≥3 antihypertensive classes or controlled BP while using ≥4 antihypertensive classes. Patients with aTRH have a higher risk for adverse cardiovascular outcomes compared to patients with controlled hypertension. Although there have been prior reports on the prevalence, characteristics, and predictors of aTRH, these have been broadly derived from smaller datasets, randomized controlled trials, or closed healthcare systems.

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Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin.

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A hypercoagulable state associated with coronavirus disease 2019 (COVID-19) has been well documented and is believed to be strongly supported by a proinflammatory state. The hypercoagulable state in turn results in increased incidence of arterial and venous thromboembolism (VTE) seen in hospitalized COVID-19 when compared with hospitalized non-COVID-19 patient cohorts. Moreover, patients with arterial or VTE and COVID-19 have higher mortality compared with COVID-19 patients without arterial or VTE.

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  • A clinical trial investigated whether therapeutic-dose anticoagulation could improve outcomes for critically ill patients with severe Covid-19 compared to standard thromboprophylaxis.
  • The study found no significant difference in organ support-free days between the two groups, with the anticoagulation group showing a median of 1 day compared to 4 days for the usual-care group.
  • The trial was halted due to a high probability of futility, with similar hospital discharge survival rates and a slightly higher occurrence of major bleeding in the anticoagulation group.
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Background: Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.

Methods: In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis.

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Background: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.

Methods: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis.

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Background: ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) is a pragmatic clinical trial examining high-dose versus low-dose aspirin among patients with cardiovascular disease. ADAPTABLE is leveraging novel approaches for clinical trial conduct to expedite study completion and reduce costs. One pivotal aspect of the trial conduct is maximizing clinician engagement.

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