Publications by authors named "Michael E Farkouh"
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
- 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.
View Article and Find Full Text PDFBackground: 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.
View Article and Find Full Text PDFBackground: 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.
Article Synopsis
- 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.
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.
Another Piece in the Diabetes and Multivessel Coronary Disease Puzzle.
JACC Cardiovasc Interv
October 2023
Article Synopsis
- - The study explored whether high-dose trivalent influenza vaccines provide better protection against serious heart and lung events compared to standard-dose quadrivalent vaccines in high-risk cardiovascular patients during flu season.
- - Conducted as a secondary analysis of the INVESTED trial from 2016 to 2019, involving 3,094 patients, the research tracked weekly flu activity and its impact on health outcomes.
- - Results indicated that increasing influenza-like illness (ILI) activity correlated with a higher risk of serious health events, but high-dose vaccines did not show a significant advantage over standard doses in preventing these issues.
STICH3C: Rationale and Study Protocol.
Circ Cardiovasc Interv
August 2023
Article Synopsis
- The STICH3C trial aims to compare the effectiveness of coronary artery bypass grafting (CABG) and contemporary percutaneous coronary intervention (PCI) in patients with ischemic left ventricular dysfunction (iLVSD) and multivessel disease.
- It is a large international study involving around 754 participants, randomized to receive either CABG or PCI, focusing on patients with significant coronary artery disease and low heart function.
- The trial will assess overall patient outcomes, including survival rates and quality of life, over a follow-up period of up to 5 years, helping to guide future treatment protocols for this patient population.
The Cox proportional hazards model is one of the most popular statistical tools to model time to event outcomes without the need for specifying the hazards or survival time distributions. The Cox model requires that the ratio of the hazards of the occurrence of the outcome for any 2 individuals remains constant during the entire follow-up. Studies comparing coronary revascularisation strategies, however, might be prone to violations of proportionality by the crossing of the hazard functions over time.
View Article and Find Full Text PDFBackground: Inflammation and coagulation may contribute to the increased risk for atherosclerotic cardiovascular disease (ASCVD) associated with high lipoprotein(a). The association of lipoprotein(a) with ASCVD is stronger in individuals with high versus low high-sensitivity C-reactive protein (hs-CRP), a marker of inflammation.
Objectives: Determine the association of lipoprotein(a) with incident ASCVD by levels of coagulation Factor VIII controlling for hs-CRP.
Background: Previous studies have failed to show a cardioprotective benefit of beta-blockers in patients with stable coronary artery disease (CAD).
Objectives: This study sought to determine the association between beta-blockers and cardiovascular events in patients with stable CAD using a new user design.
Methods: All patients aged >66 years undergoing elective coronary angiography in Ontario, Canada, from 2009 to 2019 with diagnosed obstructive CAD were included.
Background: While men have experienced higher risks of SARS-CoV-2 infection compared to women, an analysis of sex differences by age in severe outcomes during the acute phase of infection is lacking.
Objectives: The purpose of this study was to assess heterogeneity in severe outcome risks by age and sex by conducting a retrospective cohort study of community-dwelling adults in Ontario who tested positive for SARS-CoV-2 infection during the first 3 waves.
Methods: Adjusted odds ratios were estimated using multilevel multivariable logistic regression models including an interaction term for age and sex.
Article Synopsis
- The study aimed to assess the impact of P2Y12 inhibitors, specifically ticagrelor, on critically ill COVID-19 patients, as platelet activation may be a new treatment target.
- Conducted as a randomized clinical trial, it included 949 patients who were assigned to receive either the P2Y12 inhibitor or usual care for up to 14 days.
- Results showed a small increase in organ support-free days for those on the inhibitor, but the effect was uncertain due to overlapping confidence intervals, and the trial was terminated early due to slow enrollment.