Open AccessApplicability of the REDUCE‐IT trial to the FAST‐MI registry. Are the results of randomized trials relevant in routine clinical practice?
Author(s) -
Ferrières Jean,
Bataille Vincent,
Puymirat Etienne,
Schiele François,
Simon Tabassome,
Danchin Nicolas
Publication year - 2020
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23437
Subject(s) - medicine , myocardial infarction , placebo , stroke (engine) , population , clinical trial , statin , randomized controlled trial , cardiology , cause of death , disease , pathology , mechanical engineering , alternative medicine , environmental health , engineering
Background The reduction of cardiovascular events with icosapent ethyl‐intervention trial (REDUCE‐IT) trial revealed robust atherosclerotic cardiovascular risk reduction with a strategy comprising high‐dose omega‐3 icosapent ethyl vs placebo in statin‐treated patients with elevated triglycerides and controlled low‐density lipoprotein cholesterol (LDL‐C). Hypothesis Are the results of the REDUCE‐IT trial applicable to the French registry on acute ST‐elevation and non‐ST‐elevation myocardial infarction (FAST‐MI) population? Methods Data were extracted from the FAST‐MI 2010 and 2015 registries. We applied the REDUCE‐IT enrolment criteria (triglycerides 150‐500 mg/dL and LDL‐C 40‐100 mg/dL on statins) to the FAST‐MI population in patients aged ≥45 years who had detailed lipid values postacute hospitalization, focusing on their clinical profile and cardiovascular prognosis. Results Of the 3789 FAST‐MI patients with a full lipid profile (median 11.1 [IQR 7.6‐17.4] months after hospitalization for myocardial infarction), 472 (12.5%; 95% CI 11.4‐13.5) met the eligibility criteria for REDUCE‐IT (REDUCE‐IT‐like group). The cardiovascular event rate (all‐cause death, nonfatal myocardial infarction, nonfatal stroke) was 36.7 (95% CI 27.8‐48.6) per 1000 person‐years for the REDUCE‐IT‐like group, which compares with the 36.9 (95% CI 26.1‐51.5) per 1000 person‐years (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) reported in the REDUCE‐IT trial. The residual cardiovascular risk related to elevated triglycerides in the REDUCE‐IT‐like group was similar to the risk in the REDUCE‐IT trial. Conclusions If the results of REDUCE‐IT are applied to patients hospitalized for a myocardial infarction in France, 12.5% of these patients could benefit from a strategy of high‐dose omega‐3 icosapent ethyl on top of contemporary therapy including statins to improve their clinical outcomes.