Abstract
BackgroundThe risk for subsequent major cardiovascular (CV) events among patients with very high‐risk (VHR) atherosclerotic CV disease (ASCVD) remains to be fully elucidated.HypothesisWe assessed the characteristics and major CV event rates of patients with VHR versus non‐VHR ASCVD in a real‐world setting in the United States (US), hypothesizing that patients with VHR ASCVD would have higher CV event rates.MethodsThis was a retrospective cohort study conducted from January 01, 2011, to June 30, 2018, in the US using the Prognos LDL‐C database linked to the IQVIA PharMetrics Plus® database supplemented with the IQVIA prescription claims (Dx/LRx) databases. Patients were ≥18 years old and had ≥2 non‐ancillary medical claims in the linked databases at least 30 days apart. The study was conducted in 2 stages: (1) identification of patients with ASCVD who met the definition of VHR ASCVD and a matched cohort of non‐VHR ASCVD patients using the incidence density sampling (IDS) approach; (2) estimation of the occurrence of major CV events.ResultsAmong patients with ≥1 major ASCVD event (N=147,679), most qualified as VHR ASCVD (79.5%). There were 115,460 patients each in IDS‐matched VHR and non‐VHR ASCVD cohorts. The composite myocardial infarction/ischemic stroke event rates in the VHR and non‐VHR ASCVD cohorts were 8.04 (95% confidence interval [95% CI]: 7.87‐8.22) and 0.82 (95% CI: 0.77‐0.88) events per 100 patient‐years, respectively, during the 1‐year post‐index period.ConclusionsMost patients with ≥1 previous major ASCVD event treated in real‐world US clinical practice qualified as VHR ASCVD. Patients with VHR ASCVD had much higher rates of major CV events versus non‐VHR ASCVD patients.
Highlights
Low-density lipoprotein cholesterol (LDL-C) is a modifiable causal risk factor in the pathogenesis of atherosclerotic cardiovascular (CV) disease (ASCVD),[1] with lower LDL-C levels associated with a reduced risk of CV events and improved patient outcomes.[2,3,4,5,6] Updates in the 2018 American College of Cardiology/American Heart Association (ACC/AHA) multi-society blood cholesterol guideline introduced the very high-risk (VHR) atherosclerotic CV disease (ASCVD) category.[7]
Informed by the introduction of the VHR ASCVD criteria in the ACC/AHA 2018 guideline for the management of blood cholesterol,[7] this observational retrospective cohort study from routine clinical practice provides new and important data on the clinical characteristics, treatment patterns, and risk of major CV events in patients with VHR versus non-VHR ASCVD treated in United States (US) healthcare settings
Despite clinical guidelines recommending that all patients with ASCVD take a high-intensity statin or the maximally tolerated statin dosage,[7] only 51.7% of patients with VHR ASCVD received lipid-lowering therapy (LLT) with a statin and/or ezetimibe, and most of these patients still had suboptimally controlled LDL-C ≥70 mg/dL (≥1.8 mmol/L)
Summary
Low-density lipoprotein cholesterol (LDL-C) is a modifiable causal risk factor in the pathogenesis of atherosclerotic cardiovascular (CV) disease (ASCVD),[1] with lower LDL-C levels associated with a reduced risk of CV events and improved patient outcomes.[2,3,4,5,6] Updates in the 2018 American College of Cardiology/American Heart Association (ACC/AHA) multi-society blood cholesterol guideline introduced the very high-risk (VHR) ASCVD category.[7]. Real-world characterization of the VHR ASCVD population is important as these patients are likely to benefit from intensive LLT with the addition of non-statin therapies such as PCSK9 inhibitors.[4,5,6,8,9] the current study had two objectives: first, to describe patient characteristics, utilization of LLT, and LDL-C levels among patients with ASCVD who met the definition of VHR per the 2018 ACC/AHA cholesterol guideline[7] versus patients with ASCVD not meeting the VHR criteria; and second, to estimate the rates of subsequent major CV events in VHR ASCVD and non-VHR ASCVD cohorts, with analyses by type of major ASCVD event. Patients with VHR ASCVD had much higher rates of major CV events versus non-VHR ASCVD patients
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