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Canadian Journal of Cardiology

Statin Use in Primary Prevention: A Simple Trial-Based Approach Compared With Guideline-Recommended Risk Algorithms for Selection of Eligible Patients

Published:March 18, 2019DOI:https://doi.org/10.1016/j.cjca.2019.03.002

      Abstract

      Background

      Cardiovascular disease risk assessment tools help identify individuals likely to benefit from preventative therapies. In this study we compared outcomes using the American College of Cardiology/American Heart Association (ACC/AHA) risk algorithm and the Framingham Risk Score (FRS) tool in the Heart Outcomes Prevention Evaluation (HOPE)-3 study.

      Methods

      We compared outcomes using the ACC/AHA algorithm and the FRS with those seen in HOPE-3, which randomized participants to 10 mg rosuvastatin or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; second coprimary outcome additionally included heart failure, cardiac arrest, and revascularization.

      Results

      Relative risks using risk scores were similar to those observed in the HOPE-3. Hazards ratios for the first coprimary outcome according to risk categories of ≤ 10%, 10%-20%, and ≥ 20% using the ACC/AHA algorithm were 0.82 (95% confidence interval [CI], 0.53-1.28), 0.72 (95% CI, 0.53-0.96), and 0.72 (95% CI, 0.55-0.93), and absolute risk reduction (ARR) of 0.18%, 1.33%, and 1.85%, respectively, over a median of 5.6 years. Corresponding results using the FRS were 0.69 (95% CI, 0.36-1.35), 0.73 (95% CI, 0.52-1.01), and 0.75 (95% CI, 0.60- 0.94); and ARR of 1.32%, 0.61%, and 1.43%. Hazard ratios for the second coprimary outcome were 0.77 (95% CI, 0.51-1.14), 0.73 (95% CI, 0.56-0.95), and 0.74 (95% CI, 0.58-0.94); and ARR of 0.36%, 1.49%, and 1.85%, using the ACC/AHA algorithm and 0.76 (95% CI, 0.41-1.41), 0.70 (95% CI, 0.52-0.95), and 0.76 (95% CI, 0.62-0.94); and ARR of 1.08%, 0.83%, and 1.56% using the FRS.

      Conclusions

      The pragmatic HOPE-3 trial approach identifies in an ethnically diverse primary prevention population individuals at intermediate risk who benefit from statin therapy using simple clinical characteristics without the need for complex, currently used risk assessment tools.

      Résumé

      Introduction

      Les outils d’évaluation du risque de maladie cardiovasculaire permettent de repérer les patients qui pourraient bénéficier d’un traitement préventif. Nous avons donc comparé les résultats obtenus au moyen de l’algorithme d’évaluation du risque de l’American College of Cardiology/American Heart Association (ACC/AHA) et au moyen de l’outil d’évaluation du score de risque de Framingham (SRF) dans le cadre de l’étude HOPE-3 (Heart Outcomes Prevention Evaluation).

      Méthodes

      Nous avons utilisé l’algorithme de l’ACC/AHA et le SRF pour évaluer les résultats obtenus au cours de l’étude HOPE-3, dans laquelle les participants ont été répartis aléatoirement pour recevoir de la rosuvastatine à 10 mg ou un placebo. Le premier coparamètre principal regroupait le décès d’origine cardiovasculaire, l’infarctus du myocarde non mortel et l’accident vasculaire cérébral non mortel; le deuxième coparamètre principal regroupait l’insuffisance cardiaque, l’arrêt cardiaque et la nécessité d’une revascularisation.

      Résultats

      Les risques relatifs établis selon les scores de risque étaient comparables à ceux observés dans le cadre de l’étude HOPE-3. Les rapports des risques instantanés relatifs au premier coparamètre principal correspondant aux catégories de risque ≤ 10 %, de 10 % à 20 % et ≥ 20 % définies selon l’algorithme de l’ACC/AHA s’établissaient respectivement à 0,82 (intervalle de confiance [IC] à 95 %, de 0,53 à 1,28), à 0,72 (IC à 95 %, de 0,53 à 0,96) et à 0,72 (IC à 95 %, de 0,55 à 0,93), et la réduction du risque absolu (RRA) à 0,18 %, à 1,33 % et à 1,85 % sur une période médiane de 5,6 ans. Les résultats correspondants obtenus au moyen du SRF étaient de 0,69 (IC à 95 %, de 0,36 à 1,35), de 0,73 (IC à 95 %, de 0,52 à 1,01) et de 0,75 (IC à 95 %, de 0,60 à 0,94), avec une RRA de 1,32 %, de 0,61 % et de 1,43 %. Les rapports des risques instantanés pour le deuxième coparamètre principal s’établissaient à 0,77 (IC à 95 %, de 0,51 à 1,14), à 0,73 (IC à 95 %, de 0,56 à 0,95) et à 0,74 (IC à 95 %, de 0,58 à 0,94), avec une RRA de 0,36 %, de 1,49 % et de 1,85 % selon l’algorithme de l’ACC/AHA, et à 0,76 (IC à 95 %, de 0,41 à 1,41), à 0,70 (IC à 95 %, de 0,52 à 0,95) et à 0,76 (IC à 95 %, de 0,62 à 0,94), avec une RRA de 1,08 %, de 0,83 % et de 1,56 % selon le SRF.

      Conclusions

      À l’aide de caractéristiques cliniques simples et sans recourir aux outils d’évaluation du risque complexes actuels, l’approche pragmatique mise en œuvre dans le cadre de l’étude HOPE-3 permet de repérer dans une population de patients de différentes origines ethniques en prévention primaire ceux qui présentent un risque intermédiaire et qui pourraient bénéficier d’un traitement par une statine.
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      Linked Article

      • To Risk Stratify or Not for Statin Therapy
        Canadian Journal of CardiologyVol. 35Issue 5
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          The 2016 Canadian Cardiovascular Society (CCS) guidelines for the management of dyslipidemia1 recommend the use of statin treatment for the primary prevention of cardiovascular (CV) events in: (1) patients with a high risk (10 year incidence of > 20%) of CV disease, calculated using the Framingham Risk Score (FRS); and (2) patients with an intermediate risk (FRS 10%-20%) with (i) low-density lipoprotein (LDL) cholesterol > 3.5 mmol/L, or (ii) LDL cholesterol < 3.5 mmol/L but non-high-density lipoprotein (HDL) > 4.3 mmol/L or apolipoprotein B > 1.2 g/L, or (iii) men 50 years of age and older and women 60 years of age and older with additional CV risk factors that include low HDL cholesterol, impaired fasting glucose, increased waist circumference, cigarette smoking, and hypertension (with additional risk factors that include left ventricular hypertrophy).
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