Publications by authors named "Shaun Goodman"

Background: Clinical guidelines have concluded that there are insufficient data to provide recommendations for the hemoglobin threshold for the use of red cell transfusion in patients with acute myocardial infarction (MI) and anemia. After the recent publication of the Myocardial Infarction and Transfusion (MINT) trial, we performed an individual patient-level data meta-analysis to evaluate the effect of restrictive versus liberal blood transfusion strategies.

Methods: We conducted searches in major databases.

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  • Traditional analyses in clinical trials for antithrombotic agents evaluate bleeding and ischemic events separately, which have limitations; this study proposes using days alive and out of hospital (DAOH) as an alternative endpoint.
  • The AUGUSTUS trial involving 4614 patients compared two treatments (apixaban vs. warfarin and aspirin vs. placebo) and measured DAOH, finding no significant differences between treatment groups.
  • Despite apixaban showing lower rates of major bleeding and hospitalization, the study concludes that DAOH may not effectively capture the impact of antithrombotic therapies for patients with atrial fibrillation and acute coronary syndrome.
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Background: In the AUGUSTUS trial (An Open-Label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention), the combination of dual antiplatelet therapy plus oral anticoagulation increased the risk of bleeding without reducing ischemic events compared with a P2Y12 inhibitor plus oral anticoagulation among patients with atrial fibrillation and acute coronary syndrome or elective percutaneous coronary intervention. However, AUGUSTUS enrolled patients up to 14 days after acute coronary syndrome or percutaneous coronary intervention, and there may be a benefit to dual antiplatelet therapy plus oral anticoagulation early after an ischemic event.

Methods: In this secondary analysis of AUGUSTUS, we divided patients into groups based on whether they were enrolled <6 days (early) or ≥6 days (later) after their index acute coronary syndrome or percutaneous coronary intervention, and tested the interaction between time from the index event to enrollment and randomized treatment (apixaban versus vitamin K antagonist and aspirin versus placebo) on 30-day and 6-month clinical outcomes using Cox proportional hazards models.

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  • * The AUGUSTUS trial compared the safety of antithrombotic treatments (apixaban vs vitamin K antagonists and aspirin vs placebo) in patients categorized by the number of comorbidities.
  • * Results showed that higher comorbidity levels increased bleeding risks, but no significant differences in outcomes between the antithrombotic regimens were observed, supporting the use of apixaban plus a P2Y inhibitor.
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Background: The optimal hemoglobin threshold to guide red blood cell (RBC) transfusion for patients with acute myocardial infarction (MI) and anemia is uncertain.

Objective: To estimate the efficacy of 4 individual hemoglobin thresholds (<10 g/dL [<100 g/L], <9 g/dL [<90 g/L], <8 g/dL [<80 g/L], and <7 g/dL [<70 g/L]) to guide transfusion in patients with acute MI and anemia.

Design: Prespecified secondary analysis of the MINT (Myocardial Ischemia and Transfusion) trial using target trial emulation methods.

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Background: In Canada, COPD represents a significant burden to the patient and health system, as it is often under or misdiagnosed and sub-optimally treated. Cardiovascular disease (CVD) is a common co-morbidity in COPD and there is significant interplay between these two chronic conditions. Across all stages of COPD disease severity, deaths can be attributed not only to respiratory causes but also to cardiovascular-related factors.

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Background: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) demonstrated greater health status benefits with an initial invasive strategy, as compared with a conservative one, for patients with chronic coronary disease and moderate or severe ischemia. Whether these benefits vary globally is important to understand to support global adoption of the results.

Methods: We analyzed participants' disease-specific health status using the validated 7-item Seattle Angina Questionnaire (SAQ: >5-point differences are clinically important) at baseline and over 1-year follow-up across 37 countries in 6 international regions.

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  • The study investigates the relationship between triglyceride levels and the cardiovascular benefits of alirocumab compared to placebo in patients with recent acute coronary syndrome (ACS) who are on statin therapy.
  • Results showed that higher baseline triglyceride levels were linked to an increased risk of major adverse cardiovascular events (MACE), whereas alirocumab significantly lowered LDL cholesterol and reduced MACE risk.
  • While alirocumab led to a notable decrease in triglycerides, the reduction did not correlate with a lower risk of MACE, suggesting baseline triglyceride levels are more important for cardiovascular risk than reductions achieved through treatment.
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Background: Following an acute myocardial infarction (AMI), patients remain at risk for subsequent cardiovascular (CV) events. In the AEGIS-II trial, CSL112, a human apolipoprotein A-I derived from plasma that enhances cholesterol efflux, did not significantly reduce the first occurrence of CV death, myocardial infarction (MI), or stroke through 90 days compared with placebo. However, an analysis involving only the first event may not capture the totality of the clinical impact of an intervention because patients may experience multiple events.

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Background: Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding.

Methods: In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 1:1 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban.

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Background And Aims: In the AEGIS-II trial (NCT03473223), CSL112, a human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity, did not significantly reduce the risk of the primary endpoint through 90 days vs. placebo after acute myocardial infarction (MI). Nevertheless, given the well-established relationship between higher low-density lipoprotein cholesterol (LDL-C) and plaque burden, as well as greater risk reductions seen with PCSK9 inhibitors in patients with baseline LDL-C ≥ 100 mg/dL on statin therapy, the efficacy of CSL112 may be influenced by baseline LDL-C.

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Background: The MINT trial (Myocardial Ischemia and Transfusion) raised concern for harm from a restrictive versus liberal transfusion strategy in patients with acute myocardial infarction (MI) and anemia. Type 1 and type 2 MI are distinct pathophysiologic entities that may respond differently to blood transfusion. This analysis sought to determine whether the effects of transfusion varied among patients with a type 1 or a type 2 MI and anemia.

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  • SGLT2 inhibitors like empagliflozin can improve heart failure outcomes in type 2 diabetes, but how they work is still not well understood.
  • A study involving 90 patients with coronary artery disease and type 2 diabetes assessed the effects of empagliflozin on left atrial (LA) volume and function over 6 months.
  • The results showed no significant changes in LA volume or function between the empagliflozin group and the placebo group, indicating that the drug may not impact these specific heart aspects.
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Background: The optimal antithrombotic regimen for patients with atrial fibrillation (AF) who had an acute coronary syndrome (ACS) or have undergone percutaneous coronary intervention (PCI) is not known.

Objectives: The authors sought to determine which antithrombotic regimen best balances safety and efficacy.

Methods: AUGUSTUS, a multicenter 2 × 2 factorial design randomized trial compared apixaban with vitamin K antagonist (VKA) and aspirin with placebo in patients with AF with recent ACS and/or PCI treated with a P2Y inhibitor.

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This article examines the care gaps in lipid-lowering therapy for atherosclerotic cardiovascular disease (ASCVD), primarily focusing on discrepancies between recommended practices and actual clinical implementation. It provides an overview of the different challenges in lipid management following percutaneous coronary intervention (PCI) and acute coronary syndrome (ACS). Studies reveal gaps in lipid testing and treatment adequacy post-PCI and ACS, as well as knowledge and practice gaps among primary care practitioners, particularly in adhering to the latest lipid guidelines.

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  • - The ODYSSEY OUTCOMES trial evaluated the impact of alirocumab, a drug that targets cholesterol, compared to a placebo on major cardiovascular events in patients with recent acute coronary syndrome, involving over 18,000 participants.
  • - Results showed that while both men and women experienced significant reductions in cholesterol levels and cardiovascular events with alirocumab, women had higher initial cholesterol and lipoprotein(a) levels and more co-morbidities.
  • - The study concluded that alirocumab improves cardiovascular outcomes post-acute coronary syndrome for both sexes, especially in individuals with higher baseline levels of lipoprotein(a).
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Background: In the CLEAR (Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen) Outcomes trial, treatment of statin-intolerant patients with bempedoic acid produced a 21% decrease in low-density lipoprotein cholesterol (LDL-C) relative to placebo and a 13% relative reduction in the risk of major adverse cardiovascular events.

Objectives: This study sought to determine whether the relationship between LDL-C lowering and cardiovascular benefit achieved with bempedoic acid resembles that observed with statins when standardized per unit change in LDL-C.

Methods: To compare the treatment effect of bempedoic acid with statins, the methodology of the Cholesterol Treatment Trialists' Collaboration (CTTC) was applied to outcomes among the 13,970 patients enrolled in the CLEAR Outcomes trial.

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  • This study examined the impact of high-dose influenza vaccination on patients with adult congenital heart disease (ACHD) compared to those without ACHD, focusing on all-cause mortality and cardiopulmonary hospitalizations.
  • 272 ACHD patients were included, revealing that they were generally younger and had specific health conditions compared to the non-ACHD group of 4,988 individuals.
  • Results showed no significant difference in the primary outcomes between ACHD and non-ACHD groups, indicating that both high- and standard-dose vaccines had similar effects on health outcomes.
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  • The study looked at how safe and effective different blood-thinning treatments are for people with heart issues, focusing on older ages.
  • It included patients divided into three age groups: under 65, 65-74, and 75 or older, to see how these treatments affected bleeding and other health problems.
  • The results showed that a medication called apixaban caused less bleeding than another medication (VKA), while aspirin led to more bleeding for everyone, so using apixaban with different treatments is recommended instead of using aspirin.
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Inflammation mediated by interleukin-6 (IL-6) is strongly associated with cardiovascular risk. Here we evaluated clazakizumab, a monoclonal antibody targeting the IL-6 ligand, in a phase 2b dose-finding study. Adults with cardiovascular disease and/or diabetes receiving maintenance dialysis with high-sensitivity C-reactive protein (hs-CRP) ≥ 2 mg l at baseline were randomized to receive clazakizumab (2.

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Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost.

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  • DAOH (Days Alive Out of Hospital) is a key end point for assessing patient outcomes in atrial fibrillation treatments, but its clinical utility has not been previously explored in trials.
  • The ROCKET AF trial compared the effectiveness of rivaroxaban and warfarin in patients with atrial fibrillation, revealing similar DAOH outcomes for both treatments, indicating no significant benefit of one over the other.
  • Overall, low event rates among participants led to a skewed distribution in DAOH measurements, which may explain the lack of treatment differences observed in the study.
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