Pulmonary vascular disease & thromboembolism
Preserving Trial Endpoint Specificity and Cause of Death Attribution in Cardiovascular Trials: Insights From MARINER
Authors' conclusion
This post-hoc, exploratory analysis of endpoint design demonstrates that designing specific trial endpoints can minimize the risk of type II error. In the trial design stage, it is important to preserve endpoint specificity to allow accurate hypothesis testing. Using standardized endpoint definitions, such as for VTE-related death, across trials can help achieve this goal.
Study context
- Population
- Deaths in the MARINER trial of rivaroxaban vs placebo on venous thromboembolism (VTE) following discharge in high-risk medical inpatientsdeaths in the MARINER trial
- Participants
- 241 deaths
- Comparison
- Rivaroxaban vs placebo
- Primary endpoint
- Readjudicated MARINER primary endpoint using only confirmed fatal VTE events
Methodological detailsreadjudication of death endpoints, blinded adjudicators not involved with the original trial
- Readjudication of death endpoints
- Blinded adjudicators not involved with the original trial
Primary result
As reported in the abstract
rivaroxaban vs placeboHazard ratio (95% CI)
Readjudicated
0.46(0.23–0.91)
Original HR 0.76 (95% CI 0.52-1.1)
0.46(0.23–0.91)
Further findings
Concordance of rereviewed death cases with original results
- Deaths originally categorized as "Cannot rule out pulmonary embolism" redistributed to undetermined death
- 60%
- Strong concordance with original results
Original publication
Preserving Trial Endpoint Specificity and Cause of Death Attribution in Cardiovascular Trials: Insights From MARINER. JACC Adv. Published 12 May 2025. doi:10.
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