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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Article info
Publication history
Published online: March 18, 2019
Accepted:
March 12,
2019
Received:
November 30,
2018
Footnotes
See editorial by Fitchett, pages 550–551 of this issue.
See page 651 for disclosure information.
Identification
Copyright
Crown Copyright © 2019 Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- To Risk Stratify or Not for Statin TherapyCanadian Journal of CardiologyVol. 35Issue 5
- PreviewThe 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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