Randomized controlled trial2017

Early initiation of eicosapentaenoic acid and statin treatment is associated with better clinical outcomes than statin alone in patients with acute coronary syndromes: 1-year outcomes of a randomized controlled study

Nosaka K, Miyoshi T, Iwamoto M, Kajiya M, Okawa K, Tsukuda S, Yokohama F, Sogo M, Nishibe T, Matsuo N, Hirohata S, Ito H, Doi M

International journal of cardiology · 72 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Clinical events such as disease or death

Who paid for it

Funding
Funding not disclosed

Publication

Published
2016-11-09 · Int J Cardiol · vol. 228 · pp. 173–179
Publisher
Elsevier BV
Cited
88 citations · more than 98% of similar papers · 7.2× the field average
Impact
Top 10% most cited in its field
References
44 works
Access
Open access (hybrid journal) · CC-BY-NC-ND
Research areas
Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Eicosanoids and Hypertension Pharmacology
Keywords
Medicine, Internal medicine, Hazard ratio, Clinical endpoint, Acute coronary syndrome, Myocardial infarction, Statin, Eicosapentaenoic acid, Percutaneous coronary intervention, Conventional PCI, Randomized controlled trial, Cardiology, Pitavastatin, Adverse effect, Confidence interval, Polyunsaturated fatty acid
MeSH
humans, quinolines, eicosapentaenoic acid, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, drug therapy, combination, drug administration schedule, prospective studies, aged, middle aged, female, male, acute coronary syndrome, percutaneous coronary intervention

13 authors

From JP

  • Kazumasa Nosaka · correspondingKagawa Prefectural Central Hospital
  • Toru Miyoshi · correspondingOkayama University
  • Mutsumi Iwamoto · correspondingKagawa Prefectural Central Hospital
  • Masahito Kajiya · correspondingKagawa Prefectural Central Hospital
  • Keisuke Okawa · correspondingKagawa Prefectural Central Hospital
  • Saori Tsukuda · correspondingKagawa Prefectural Central Hospital

Abstract

Background

Early initiation of EPA treatment in combination with a statin within 24h after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (MI) reduces inflammation and ventricular arrhythmia compared with statin monotherapy; however, the impact of early initiation of EPA treatment on cardiovascular events is unclear. We determined whether early eicosapentaenoic acid (EPA) treatment in patients with acute coronary syndrome (ACS) reduces adverse cardiovascular events.

Methods

This prospective, open-label, blind end point-randomized trial consisted of 241 patients with ACS. Patients were randomly assigned to receive pitavastatin (2mg/day) with or without 1800mg/day of EPA initiated within 24h after PCI. The primary endpoint was defined as cardiovascular events occurring within 1year, including death from a cardiovascular cause, nonfatal stroke, nonfatal MI and revascularization.

Results

The mean EPA/arachidonic acid ratio at follow-up was 0.40 in the control group and 1.15 in the EPA group. A primary endpoint event occurred in 11 patients (9.2%) in the EPA group and 24 patients (20.2%) in the control group (absolute risk reduction, 11.0%; hazard ratio, 0.42; 95% confidence interval, 0.21 to 0.87; P=0.02). Notably, death from a cardiovascular cause at 1year was significantly lower in the EPA group than in the control group (0.8% vs. 4.2%, P=0.04).

Conclusions

Early initiation of treatment with EPA combined with statin after successful primary PCI reduced cardiovascular events after ACS.

Clinical trial registration

UMIN Clinical Trials Registry (UMIN-CTR); Registry Number, UMIN000016723; URL, http://www.umin.ac.jp/ctr/index-j.htm.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).

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