Publications by authors named "Michael Farkouh"
Background: In patients with diabetes and multivessel coronary artery disease, percutaneous coronary intervention (PCI) has been associated with higher long-term cardiovascular mortality compared to coronary artery bypass grafting (CABG), but the specific causes of death are not well known. We aimed to determine the causes of death among patients with diabetes and multivessel disease undergoing coronary revascularization with PCI versus CABG.
Methods: We analyzed the centrally adjudicated causes of death of 1,900 participants in the FREEDOM trial.
Anticoagulation Among Patients Hospitalized for COVID-19 : A Systematic Review and Prospective Meta-analysis.
Ann Intern Med
December 2024
Background: Reported results of clinical trials assessing higher-dose anticoagulation in patients hospitalized for COVID-19 have been inconsistent.
Purpose: To estimate the association of higher- versus lower-dose anticoagulation with clinical outcomes.
Data Sources: Randomized trials were identified from the World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.
Objective: Event capture in clinical trials is resource-intensive, and electronic medical records (EMRs) offer a potential solution. This study develops algorithms for EMR-based death and hospitalization capture and compares them with traditional event capture methods.
Materials And Methods: We compared the effectiveness of EMR-based event capture and site-captured events adjudicated by a clinical endpoint committee in the multi-center INfluenza Vaccine to Effectively Stop cardio Thoracic Events and Decompensated heart failure (INVESTED) trial for participants from the Veterans Affairs healthcare system.
Article Synopsis
- CYP2C19 loss of function carriers face a higher risk of ischemic events when treated with clopidogrel during PCI.
- In the TAILOR-PCI study, patients were randomized to receive either clopidogrel or a genotype-guided therapy where LOF carriers were prescribed ticagrelor.
- Although direct medical costs were similar between the two groups, total costs were higher for the GG group mainly due to the more expensive ticagrelor medication.
Article Synopsis
- The study investigates the best revascularization method for diabetic patients with multivessel disease who experience a non-ST-segment elevation myocardial infarction (NSTEMI), comparing coronary artery bypass grafting (CABG) and multivessel percutaneous coronary intervention (PCI).
- It involves a large cohort of over 11,000 patients and reveals that CABG is linked to lower all-cause mortality than PCI, particularly in patients deemed potentially ineligible for CABG after a surgical consultation.
- The results suggest that while CABG is generally more beneficial for these patients, the advantage is more pronounced when comparing CABG to a specific group of PCI patients who had a surgical consultation beforehand.
Article Synopsis
- Community-acquired pneumonia (CAP) can lead to serious inflammatory and thrombotic responses, and the use of antiplatelet agents may positively influence patient outcomes, although their impact on non-COVID-19 CAP is unclear.
- A systematic review and meta-analysis examined the effects of antiplatelet agents on mortality in hospitalized patients with non-COVID-19 CAP, analyzing data from observational studies and randomized controlled trials (RCTs).
- The findings suggest that antiplatelet agents are linked to lower mortality in observational studies, but the evidence from RCTs is inconclusive and overall trust in the results is low due to potential biases.
Article Synopsis
- - The study aimed to replicate a previous finding that EDTA-based chelation therapy reduces cardiovascular disease (CVD) events in individuals with diabetes and a history of myocardial infarction (MI).
- - Conducted at 88 sites in the US and Canada, the trial involved 959 participants who were randomly assigned to receive either chelation therapy or a placebo, with a median follow-up of 48 months.
- - Results showed no significant difference in CVD events between the chelation group (35.6% experienced a primary event) and the placebo group (35.7%), indicating that chelation may not provide the hoped-for benefits in this population.
Background: We aimed to perform a meta-analysis of randomized trials comparing long-term outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) for severe aortic stenosis. The short-term efficacy and safety of TAVR are proven, but long-term outcomes are unclear.
Methods: We included randomized controlled trials comparing TAVR vs SAVR at the longest available follow-up.
Mineralocorticoid Receptor Antagonism Prevents Aortic Plaque Progression and Reduces Left Ventricular Mass and Fibrosis in Patients With Type 2 Diabetes and Chronic Kidney Disease: The MAGMA Trial.
Circulation
August 2024
Background: Persistent mineralocorticoid receptor activation is a pathologic response in type 2 diabetes and chronic kidney disease. Whereas mineralocorticoid receptor antagonists are beneficial in reducing cardiovascular complications, direct mechanistic pathways for these effects in humans are lacking.
Methods: The MAGMA trial (Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis) was a randomized, double-blind, placebo-controlled trial in patients with high-risk type 2 diabetes with chronic kidney disease (not receiving dialysis) on maximum tolerated renin-angiotensin system blockade.
Background: Inflammation and immunity contribute pivotally to diverse acute and chronic diseases. Inflammatory pathways have become increasingly targets for therapy. Yet, despite substantial similarity in mechanisms and pathways, the scientific, medical, pharma and biotechnology sectors have generally focused programs finely on a single disease entity or organ system.
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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.
Background: Clinical trials suggest that therapeutic-dose heparin may prevent critical illness and vascular complications due to COVID-19, but knowledge gaps exist regarding the efficacy of therapeutic heparin including its comparative effect relative to intermediate-dose anticoagulation.
Objectives: The authors performed 2 complementary secondary analyses of a completed randomized clinical trial: 1) a prespecified per-protocol analysis; and 2) an exploratory dose-based analysis to compare the effect of therapeutic-dose heparin with low- and intermediate-dose heparin.
Methods: Patients who received initial anticoagulation dosed consistently with randomization were included.
This study shows that we can use synthetic cohorts created from medical risk calculators to gain insights into how risk estimations, clinical reasoning, data-driven subgrouping, and the confidence in risk calculator scores are connected. When prediction variables aren't evenly distributed in these synthetic cohorts, they can be used to group similar cases together, revealing new insights about how cohorts behave. We also found that the confidence in predictions made by these calculators can vary depending on patient characteristics.
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- Clinical trials are increasingly adopting Bayesian methods for design and analysis, using simulation-based approaches like Markov Chain Monte Carlo (MCMC), which can be computationally expensive and complex.
- The Integrated Nested Laplace Approximations (INLA) algorithm offers a more efficient alternative to MCMC for approximate Bayesian inference without heavy simulation costs.
- Research using data from a COVID-19 trial will compare INLA and MCMC to assess INLA's feasibility and accuracy for Bayesian trial design, providing insights for trialists.
Background: Debates persist regarding the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Recent trials have introduced a novel approach involving P2Y12 inhibitor monotherapy with ticagrelor or clopidogrel, after a short DAPT. However, the effectiveness and safety of this strategy remains to be established.
View Article and Find Full Text PDFIntroduction: The cardiovascular disease risk reduction benefits of proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibodies (PCSK9i mAb) and ezetimibe are dependent on remaining on treatment and being persistent and adherent. We estimated the percentage of patients on therapy, persistent and adherent at 182 and 365 days among US adults with health insurance who initiated a PCSK9i mAb (n = 16,588) or ezetimibe (n = 83,086) between July 2015 and December 2019.
Methods: Using pharmacy fill claims, being on therapy was defined as having a day of medication supply in the last 60 of 182 and 365 days following treatment initiation, being persistent was defined as not having a gap of 60 days or more between the last day of supply from one prescription fill and the next fill, and being adherent was defined by having medication available to take on ≥ 80% of the 182 and 365 days following treatment initiation.
Cardiovascular disease has been the leading cause of death in the United States and Canada for decades. Although it affects millions of people across a multitude of backgrounds, notable disparities in cardiovascular health are observed among women and become more apparent when accounting for race and socioeconomic status. Although intrinsic sex-specific physiologic differences predispose women to poorer outcomes, social determinants of health (SDOH) and biases at both the individual provider and the larger health care system levels play an equal, if not greater, role.
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- A secondary analysis of the INVESTED trial found that high-dose trivalent influenza vaccines didn't significantly lower mortality or hospitalizations for patients with high-risk cardiovascular disease compared to standard-dose quadrivalent vaccines.
- The study focused on the antibody response to these vaccines and how it relates to clinical outcomes among patients who had recent heart issues.
- Results showed that high-dose vaccines produced a stronger antibody response for various influenza strains, indicating a better immune response despite no clear impact on health outcomes.
Cardiac surgery may lead to myocardial damage and release of cardiac biomarkers through various mechanisms such as cardiac manipulation, systemic inflammation, myocardial hypoxia, cardioplegic arrest and ischaemia caused by coronary or graft occlusion. Defining perioperative myocardial infarction (PMI) after cardiac surgery presents challenges, and the association between the current PMI definitions and postoperative outcomes remains uncertain. To address these challenges, the European Association of Cardio-Thoracic Surgery (EACTS) facilitated collaboration among a multidisciplinary group to evaluate the existing evidence on the mechanisms, diagnosis and prognostic implications of PMI after cardiac surgery.
View Article and Find Full Text PDFObjectives: To determine guideline adherence pertaining to pulmonary valve replacement (PVR) referral after tetralogy of Fallot (TOF) repair.
Methods: Children and adults with cardiovascular magnetic resonance imaging scans and at least moderate pulmonary regurgitation were prospectively enrolled in the Comprehensive Outcomes Registry Late After TOF Repair (CORRELATE). Individuals with previous PVR were excluded.
Background: Prediction of atherosclerotic cardiovascular disease (ASCVD) in primary prevention assessments exclusively with laboratory results may facilitate automated risk reporting and improve uptake of preventive therapies.
Objective: To develop and validate sex-specific prediction models for ASCVD using age and routine laboratory tests and compare their performance with that of the pooled cohort equations (PCEs).
Design: Derivation and validation of the CANHEART (Cardiovascular Health in Ambulatory Care Research Team) Lab Models.
Article Synopsis
- - In the ISCHEMIA trial, patients with stable coronary artery disease showed similar risk levels for ischemic events whether they underwent invasive treatments (like PCI or CABG) or conservative medical therapy.
- - The study specifically analyzed outcomes after revascularization, finding that CABG had a higher incidence of early primary outcome events compared to PCI, with 16.4% vs. 9.8% respectively, and many events occurring shortly after the procedures.
- - Overall, while early revascularization increased immediate risks of cardiovascular events, both CABG and PCI were linked to lower risks in the long term compared to conservative treatment, suggesting a complex risk-benefit scenario.
Digital Tool-Assisted Hospitalization Detection in the Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention Study Compared to Traditional Site-Coordinator Ascertainment: Intervention Study.
J Med Internet Res
November 2023
Article Synopsis
- The TAILOR-PCI Digital Study aimed to improve the detection of cardiovascular (CV) hospitalizations through a smartphone app that used geofencing and monthly surveys, building on the original TAILOR-PCI trial.
- The study compared the effectiveness of these digital tools against traditional methods like phone calls and health record reviews by site coordinators.
- Of 85 participants, the monthly surveys successfully identified 88.9% of CV hospitalizations, while geofencing detected only 33.3%, indicating that the digital approach may be more effective than geofencing alone.