Trial reportEuropean journal of epidemiology2026
Cocoa flavanol supplementation and prevention of cardiovascular disease: a novel analysis of the COSMOS randomized trial using "win ratio".
Trial report in European journal of epidemiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
12 authors.
Funding
Abstract
Cocoa flavanols may reduce cardiovascular disease (CVD) risk, yet large randomized trials remain inconclusive. The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) suggested a modest, nonsignificant benefit using Cox models, which do not account for event severity in composite outcomes. To address this, we applied generalized pairwise comparison (GPC), or "win ratio" (WR), to assess cocoa flavanols versus placebo on hierarchical CVD outcomes among healthy older US adults. This secondary analysis of COSMOS, a randomized, placebo-controlled, 2 × 2 factorial trial of cocoa extract and multivitamins for preventing CVD and cancer, included 21,442 adults (women ≥ 65, men ≥ 60 years) followed for a median of 3.6 years. The primary outcome was a hierarchical composite of total CVD, prioritizing: fatal CVD, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, carotid surgery, peripheral artery surgery, and hospitalized unstable angina. Analyses followed the intention-to-treat principle. GPC estimated WRs and net treatment benefits (NTBs) for cocoa flavanols versus placebo. GPC analyses showed cocoa flavanol wins of 3.41% and placebo wins of 2.87%, yielding a reciprocal WR of 0.84 (95% CI 0.72-0.99) and negative NTBs of - 0.54% (- 1.04 to - 0.03), p = 0.037. Sensitivity analyses prioritizing stroke over MI produced similar findings. By contrast, Cox regression of the same composite yielded a nonsignificant hazard ratio of 0.90 (95% CI 0.79-1.03), suggesting standard time-to-first-event models underestimated benefit. GPC "WR" analyses showed cocoa flavanols significantly reduced CVD events by accounting for event severity in the composite CVD outcome, whereas Cox regression marginally missed these effects.
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Registered trials
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