Publications by authors named "S De Wandel"
Article Synopsis
- Heart failure events in cardiovascular trials are often evaluated through centralized review, but its impact on treatment effect accuracy (in terms of hazard ratios) is uncertain.
- In a study of seven trials, positive adjudication rates for heart failure events were generally lower than for cardiovascular deaths, affecting subsequent mortality risk.
- Overall, while central adjudication showed some correlation between event types, it didn’t significantly change the results, suggesting that the need for centralized review should be tailored to each trial's objectives.
Background: Low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a]) levels are independently associated with atherosclerotic cardiovascular disease (ASCVD). However, the relationship between Lp(a) level, LDL-C level, and ASCVD risk at different thresholds is not well defined.
Methods: A participant-level meta-analysis of 27 658 participants enrolled in 6 placebo-controlled statin trials was performed to assess the association of LDL-C and Lp(a) levels with risk of fatal or nonfatal coronary heart disease events, stroke, or any coronary or carotid revascularization (ASCVD).
Article Synopsis
- Researchers studied serum levels of 4123 proteins in 1117 patients with heart failure with preserved ejection fraction (HFpEF) to identify prognostic markers linked to clinical outcomes.
- A total of 288 proteins were found to be significantly associated with heart failure hospitalization and cardiovascular death, with specific proteins like B2M and TIMP1 showing strong correlations.
- The study concluded that the protein markers for HFpEF are similar to those for heart failure with reduced ejection fraction, implying that the derived proteomic risk scores do not offer improved predictive power for HFpEF patients.
Aims: To evaluate the prevalence of pathogenic variants in genes associated with dilated cardiomyopathy (DCM) in a clinical trial population with heart failure and reduced ejection fraction (HFrEF) and describe the baseline characteristics by variant carrier status.
Methods And Results: This was a post hoc analysis of the Phase 3 PARADIGM-HF trial. Forty-four genes, divided into three tiers, based on definitive, moderate or limited evidence of association with DCM, were assessed for rare predicted loss-of-function (pLoF) variants, which were prioritized using ClinVar annotations, measures of gene transcriptional output and evolutionary constraint, and pLoF confidence predictions.
The development and approval of new treatments generates large volumes of results, such as summaries of efficacy and safety. However, it is commonly overlooked that analyzing clinical study data also produces data in the form of results. For example, descriptive statistics and model predictions are data.
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