Publications by authors named "Michael Gibson"

Clinical trial design for classical hematologic diseases is difficult because samples sizes are often small and not representative of the disease population. ASH initiated a Roadmap project to identify barriers and make progress to integrate diversity, equity, and inclusion into trial design and conduct. Focus groups of international experts from across the clinical trial ecosystem were conducted.

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Purpose: After neoadjuvant therapy (NAT) and surgery, up to one third and one half of patients with esophagogastric adenocarcinoma with a pathologic complete response (pCR; tumor regression grade 0 [TRG-0]) and near-pCR (TRG-1) will recur, respectively. Our study aims to evaluate postoperative circulating tumor DNA (ctDNA) as a predictor of recurrence in patients with pCR or near-pCR after curative-intent neoadjuvant chemotherapy or neoadjuvant chemoradiation and surgery.

Methods: We retrospectively identified patients from 11 institutions with stages I-IV esophagogastric cancers (EGCs) who completed NAT and had TRG-0/1 scores at the time of curative-intent surgery.

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  • Despite progress in recognizing and diagnosing spontaneous coronary artery dissection (SCAD) in the last decade, there is still limited understanding of its mechanisms, contributing factors, and effective treatments.
  • The text highlights research gaps in SCAD and suggests strategies like patient advocacy, independent registries, and specialized centers to improve clinical care and research outcomes.
  • Additionally, it presents a patient-centered clinical care and research framework developed by the SCAD Alliance and International SCAD registry as a model to enhance understanding and management of this condition.
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Current evidence indicates that dual antiplatelet therapy with aspirin plus a P2Y inhibitor is essential for the prevention of thrombotic events after percutaneous coronary interventions. However, dual antiplatelet therapy is associated with increased bleeding which may outweigh the benefits. This has set the foundations for customizing antiplatelet treatments to the individual patient.

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Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) affects all cardiac chambers to cause left ventricular (LV) deformation as well as left atrial (LA) remodeling and functional impairment. We investigated the associations of the LA volume index (LAVI):LV ejection fraction (LVEF) ratio with the increased risk of death, heart transplant, or LV assist device implantation (LVAD) in patients with ATTR-CM.

Methods: This was a retrospective cohort study involving 69 heart failure (HF) patients with ATTR-CM at an academic medical center between 1 November 2008 and 31 March 2024.

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Background: There is concern that left internal thoracic artery (LITA)-to diagonal (D)-to left anterior descending artery (LAD) grafts may be more susceptible to failure compared with single LITA-LAD grafts.

Methods: Pooled individual patient data from 8 clinical trials with systematic graft imaging were analyzed to assess the incidence of sequential LITA-D-LAD vs single LITA-LAD grafts. Mixed-effects multivariable logistic regression, adjusting for patient characteristics and clustering within trials, was used.

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  • A study called PEERLESS compared two catheter methods, large-bore mechanical thrombectomy (LBMT) and catheter-directed thrombolysis (CDT), for treating intermediate-risk pulmonary embolism (PE) in 550 patients, focusing on various health outcomes.
  • The results showed that LBMT led to fewer complications and less need for intensive care compared to CDT, including lower rates of clinical deterioration and ICU admissions.
  • Although LBMT had better short-term outcomes, there were no significant differences in mortality or major bleeding between the two treatment methods after 30 days.
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Purpose Of Review: This review highlights advances and recent changes in the treatment paradigm for advanced esophageal adenocarcinoma (EAC) and gastroesophageal junction adenocarcinoma (GEJAC).

Recent Findings: Chemotherapy remains the backbone of treatment for advanced EAC/GEJAC. New targets/agents include immunotherapy, HER-2, claudin18.

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  • The study evaluates the impact of early discontinuation of aspirin in favor of ticagrelor monotherapy on bleeding and ischemic events in patients who underwent percutaneous coronary intervention (PCI).
  • Results show that while ticagrelor monotherapy led to significantly fewer bleeding events compared to ticagrelor plus aspirin, the total ischemic events remained similar between the two groups.
  • Overall, among high-risk PCI patients, ticagrelor alone was associated with reduced bleeding without increasing the risk of ischemic complications.
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Cardiovascular clinical trials continue to under-represent children, older adults, females and people from ethnic minority groups relative to population disease distribution. Here we describe strategies to foster trial representativeness, with proposed actions at the levels of trial funding, design, conduct and dissemination. In particular, trial representativeness may be increased through broad recruitment strategies and site selection criteria that reflect the diversity of patients in the catchment area, as well as limiting unjustified exclusion criteria and using pragmatic designs that minimize research burden on patients (including embedded and decentralized trials).

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Ischemia/reperfusion (I/R) injury leads to apoptosis and extensive cellular and mitochondrial damage, triggered by the early generation and subsequent accumulation of mitochondrial reactive oxygen species (mtROS). This condition not only contributes to the pathology of I/R injury itself but is also implicated in a variety of other diseases, especially within the cardiovascular domain. Addressing mitochondrial oxidative stress thus emerges as a critical therapeutic target.

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Recent advances in cardiovascular research have increasingly emphasized oxidative stress as a central mechanism in the pathogenesis and progression of cardiovascular diseases [...

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Aims: Intravenous (IV) therapies have transformed the management of various cardiovascular conditions in ambulatory patients. However, uptake of these therapies in ambulatory care settings has several barriers. In this systematic scoping review, we aimed to identify the barriers and facilitators that influence the implementation of current IV therapies in ambulatory settings.

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Background: Pulmonary embolism (PE) is the third-leading cause of cardiovascular mortality, accounting for 100,000 deaths per year in the United States. Although sex-based disparities have previously been described in this population, it is unclear if these differences have persisted with the expansion of PE evaluation and treatment approaches. The purpose of this study is to investigate sex-based differences in the evaluation, management, and outcomes of patients with acute PE.

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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: Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation.

Methods: A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent.

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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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  • Direct oral anticoagulants are commonly used for preventing strokes in patients with atrial fibrillation and flutter, but concerns about bleeding limit their use; milvexian is a new drug that might work as well with less bleeding risk.
  • The LIBREXIA AF trial is a large global study comparing milvexian to apixaban, enrolling 15,500 participants to assess if milvexian can prevent strokes without increasing bleeding events significantly.
  • The results from this study aim to clarify the efficacy and safety of milvexian compared to apixaban over a projected 4-year follow-up period.
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  • * The rise of technology and global connectivity supports the use of these tools, yet challenges persist in treatment effectiveness, especially in lower-income regions.
  • * To maximize the benefits of digital health tools, it's essential to create supportive systems and clinical frameworks that can be applied worldwide.
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Background: Mechanical thrombectomy (MT) is playing an increasingly important role in treating deep vein thrombosis (DVT). Although degrees of safety and efficacy have been shown in independent studies, there remains a lack of comparative evidence between MT devices. To address this, we aimed to compare demographics, clinical outcomes, and resource metrics of patients receiving MT for DVT with 3 common devices using a real-world database.

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  • Doctors pick blood-thinning medicines (called anticoagulants) based on individual patient needs and how well the medicines work without causing too much bleeding.
  • Newer medicines called direct oral anticoagulants are better than older ones, but they can still cause bleeding issues.
  • Studies show that people with a certain genetic condition (factor XI deficiency) have a lower chance of blood clots and strokes without more bleeding, which makes targeting factor XI an exciting option for new blood thinners.
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  • * Recent studies have raised concerns about this 12-month regimen, suggesting adjustments based on patients' bleeding or ischemic risks, arguing some may benefit from shorter or longer durations.
  • * Several strategies to modify DAPT practices, such as de-escalating to less potent medications or shortening therapy, have shown to reduce bleeding risks without significantly increasing cardiovascular issues, yet the 12-month recommendation remains unchanged in guidelines.
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