Real-world cardiovascular disease burden in patients with atherosclerotic cardiovascular disease: a comprehensive systematic literature review

<p><b>Objective</b>: Based on randomized controlled trials (RCT), non-fatal myocardial infarction (MI) rates range between 9-15 events per 1,000 person-year, ischemic stroke between 4-6 per 1,000 person-year, CHD death rates between 5-7 events per 1,000 person-year, any major vascular event between 28-53 per 1,000 person-year in patients with atherosclerotic cardiovascular disease (ASCVD). We reviewed global literature on the topic to determine if the real-world burden of secondary major adverse cardiovascular events (MACEs) is higher among ASCVD patients.</p> <p><b>Methods</b>: We searched PubMed and Embase using MeSH/keywords including cardiovascular disease, secondary prevention, and observational studies. Studies published in the last 5 years, in English, included ≥50 subjects with elevated low-density lipoprotein cholesterol (LDL-C) or on statins, and reported secondary MACEs were included. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of each included study.</p> <p><b>Results</b>: Of 4,663 identified articles, 14 studies that reported MACE incidence rates per 1,000 person-years were included in the review (NOS grades ranged 8-9; 2 were prospective and 12 were retrospective studies). Reported incidence rates per 1,000 person-years ranged (median) 12.01-39.9 (26.8) for MI, 13.8-57.2 (41.5) for ischemic stroke, 1.0-94.5 (21.1) for CV-related mortality, 9.7-486 (52.6) for all-cause mortality. Rates were 25.8-211 (81.1) for composite of MACEs. Multiple event rates ranged (median) from 60-391 (183) events per 1,000 person-years.</p> <p><b>Conclusions</b>: Our review indicates that MACE rates observed in real-world studies are substantially higher than those reported in RCTs, suggesting that the secondary MACE burden and potential benefits of effective CVD management in ASCVD patients may be underestimated if real-world data are not taken into consideration.</p>