Applicability of guideline-informing lipid-lowering clinical trials to contemporary real-world patients with atherosclerotic cardiovascular disease
Authors' conclusion
Eligibility of real-world ASCVD patients for lipid-lowering RCTs varied substantially across trials and ASCVD subtypes. Despite differences in clinical characteristics, trial-eligible and ineligible patients generally had comparable outcomes, suggesting that guideline-informing lipid-lowering trials are broadly representative of contemporary real-world ASCVD patients.
Study context
- Population
- Patients with atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), cerebrovascular disease, peripheral artery disease (PAD)) in the UCC-SMART study (2000–2023)5,673 CAD
- Participants
- 8,537 patients
- Exposure
- Trial-eligible vs trial-ineligible real-world ASCVD patients
- Outcome
- Proportion of patients meeting trial eligibility criteria; risks of recurrent CV events and all-cause mortality in eligible vs ineligible patients
- Follow-up
- Median 8.8 years (IQR 4.2-13.9)
Main finding
As reported in the abstract
Trial eligibility
Trial eligibility, CAD
9 to 85%
Trial eligibility, cerebrovascular disease (CeVD)
7 to 42%
Trial eligibility, PAD
8 to 78%
Observational data: associations, not effects.
Further findings
- Eligible and ineligible patients differed in clinical characteristics in most trials
Original publication
Applicability of guideline-informing lipid-lowering clinical trials to contemporary real-world patients with atherosclerotic cardiovascular disease. Eur Heart J Qual Care Clin Outcomes. Published 29 August 2025. doi:10.
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