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Triptan use was associated significantly with elevated risk for major adverse CV events, but absolute risk difference was small.

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Circulation, Volume 150, Issue Suppl_1, Page A4138915-A4138915, November 12, 2024. Introduction:Although extracranial major bleeding (EMB) is often transient and manageable with supportive care, there is concern that EMB may have a subsequent detrimental effect on CV outcomes. However, a causal relationship is unclear, because the association is often confounded by underlying disease and comorbidities. Clinical trial data for more comprehensive analyses via advanced modeling are limited.Research Question:What is the effect of rivaroxaban vs. warfarin on CV outcomes mediated through EMB?Aim:To determine the extent of the effect of rivaroxaban vs. warfarin on CV outcomes that is mediated through their differential impact on EMB using a novel, advanced modeling approach (EUPAS1000000168).Methods:Using 5 US observational databases from routine clinical practice (01-11-2010 to 31-12-2022), adult patients with non-valvular atrial fibrillation (NVAF) were identified to establish the target and comparator cohorts, with 1stexposure as index date. Treatment balance was achieved by matching on propensity scores derived from large-scale regularized regression. Cox proportional hazards models estimated the main effect on CV outcomes (myocardial infarction, ischemic stroke, and composite endpoint) for rivaroxaban vs warfarin, with target and comparator time-at-risk right-censored at therapy end or switch, event occurrence, or database observation end. The EMB mediation effect on outcomes was estimated by including EMB as time-varying covariate, while controlling mediator-outcome confounding by including a mediator risk score in the outcome model. Comparative analyses were conducted only when pre-specified diagnostics passed for covariate balance, equipoise, and systematic error estimated through negative controls.Results:In 5 databases, 378,384 rivaroxaban initiators were matched to 601,174 warfarin initiators with NVAF. Common comorbidities included hypertension, hyperlipidemia, coronary artery disease, and heart failure. Main effects and indirect effects (mediation effects) are in Table A.Conclusion:This analysis suggested that EMB had no impact on the effect of rivaroxaban vs. warfarin on CV outcomes. A limitation is that EMB occurrence and CV events after EMB were limited, which reduced mediation impact.

Circulation, Volume 150, Issue Suppl_1, Page A4145660-A4145660, November 12, 2024. Introduction:In the SUSTAIN-6, SELECT, and FLOW clinical trials, semaglutide improved CV outcomes for primary and secondary prevention among those with poor cardiovascular-kidney-metabolic (CKM) health. However, whether trial participants are representative of the treatment-eligible U.S. population is uncertain.Research Question:How well do the SUSTAIN-6, SELECT, and FLOW trial populations each represent their respective treatment-eligible U.S. populations?Methods:We identified U.S. adults eligible for semaglutide by applying key inclusion and exclusion criteria of the SUSTAIN-6, SELECT, and FLOW trials to the 2015 to March 2020 cycles of the National Health and Nutrition Examination Survey (NHANES). We compared baseline demographic and clinical characteristics of treatment-eligible NHANES populations (“real-world”) with those of their corresponding clinical trial populations using standardized mean differences (SMD). An absolute SMD ≥ 0.10 represents an imbalance in a given demographic or clinical characteristic between the trial and U.S. population.Results:Across the 3 trials, 39 of the 50 characteristics had an absolute SMD value ≥ 0.10 (Table). Trial participants were younger (SMD < -0.2) than the real-world populations. Women were significantly underrepresented in the SELECT and FLOW trials (SMD < -0.2). Self-reported race/ethnicity representation was imbalanced in all studies, with underrepresentation of Black (SMD < -0.2) individuals and Hispanic individuals in FLOW (SMD = -0.11). Trial subjects had higher diastolic blood pressure and HgbA1C. The greatest imbalance was that SELECT enrolled a lower proportion of patients with a history of stroke compared with the real-world population (a subgroup in which semaglutide showed equivocal CV benefit).Conclusion:Of the three semaglutide CV outcome trials that have been published, all were not representative of the treatment-eligible U.S. population. The underrepresentation of women and Black and Hispanic individuals is notable because of the disproportionate burden of poor CKM health in these groups. Evaluation of semaglutide in representative, diverse US populations is needed to examine safety, effectiveness, and cost-effectiveness in the real-world.

Circulation, Volume 150, Issue Suppl_1, Page A4145340-A4145340, November 12, 2024. Background:Nationally, many ASCVD patients fail to achieve an LDL-C

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