| アブストラクト | BACKGROUND: Evidence for the net benefit of aspirin for primary prevention of cardiovascular disease (CVD) is finely balanced, leading to variation in guideline recommendations internationally. External validity of randomised clinical trial (RCT) evidence may therefore be of particular importance. The aim of this study is to characterise real-world patients according to their eligibility for guideline-cited aspirin RCTs for primary CVD prevention. METHODS: Eligibility criteria from 14 RCTs were applied to a linked primary care/hospital discharge dataset of people >/= 40 years without CVD. Proportions eligible for each trial were calculated, and characteristics of eligible and ineligible patients compared for each trial, including Cox regression analysis of event rates for major adverse cardiovascular events (MACE), major bleeding events, and non-cardiovascular mortality. RESULTS: Of 570,211 included patients (300,500 [52.7%] women, 336,877 [59%] < 60 years), the median proportion ineligible for 14 RCTs was 90.7% (range 42.5-99.4%) and 24.0% of patients were ineligible for all RCTs. On average, trial-ineligible populations were younger (median age trial-ineligible 57.8 vs trial-eligible 62.6 years, p = 0.008) and a lower proportion had hypertension (23.9% vs 50.9%, p = 0.004), diabetes (6.4% vs 11.5%, p = 0.015), or a regular statin prescription (11.8% vs 26.7%, p = 0.001). Trial-ineligible populations had a higher hazard of MACE compared to trial-eligible in four RCTs and lower in ten (hazard ratio [HR] range across all RCTs 0.45 [95%CI 0.40-0.51] to 2.78 [95%CI 2.61-2.96]). Hazards of bleeding events in the trial-ineligible were lower than the trial-eligible in eight RCTs and higher in four (HR range across all RCTs 0.63 [95%CI, 0.59-0.66] to 1.69 [95%CI, 1.53-1.86]), and time-varying hazards of non-CVD death were consistently lower in four RCTs and higher in five (HR range across all RCTs and time points 0.29 [95%CI 0.24-0.36] to 11.42 [95%CI 9.91-13.17]). CONCLUSIONS: Compared with trial-ineligible populations within the same age and sex strata, RCTs recruited people of varying CVD risk but often excluded people at high risk of bleeding or non-CVD death, highlighting that many trials may overestimate the net benefit of aspirin for primary prevention. |
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| ジャーナル名 | BMC medicine |
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| Pubmed追加日 | 2026/1/28 |
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| 投稿者 | Holder, Michael; Morales, Daniel R; Hanlon, Peter; McAllister, David A; Guthrie, Bruce |
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| 組織名 | Advanced Care Research Centre, Usher Institute, University of Edinburgh,;Edinburgh, EH16 4UX, UK.;Division of Population Health and Genomics, University of Dundee, Dundee, UK.;General Practice and Primary Care, School of Health and Wellbeing, University of;Glasgow, Glasgow, UK.;Health Economics and Health Technology Assessment, School of Health and;Wellbeing, University of Glasgow, Glasgow, UK.;Edinburgh, EH16 4UX, UK. bruce.guthrie@ed.ac.uk. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41593683/ |
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