Findings from the STRENGTH trial (NCT02104817) were presented by Prof. Michael Lincoff (Cleveland Clinic, USA), and were simultaneously published in JAMA [1,2]. The goal of the placebo-controlled STRENGTH trial was to evaluate the combined omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in patients with dyslipidaemia and high cardiovascular risk. The primary endpoint was a composite of cardiovascular death, non-fatal heart attack, non-fatal stroke, coronary artery revascularisation, and hospitalisation for unstable angina.
A total of 13,078 patients were randomised to receive daily supplementation with 4 g omega-3 fatty acids (n=6,539) or corn oil as placebo (n=6,539) in addition to usual background therapies, including statins. The mean age of the participants was 63 years, 35% were female, and 70% had diabetes. Median follow-up was 42 months.
Prof. Lincoff explained that the trial was terminated early for futility after an interim analysis. EPA/DHA did not reduce the incidence of major adverse cardiovascular events, despite a 269% increase in plasma EPA levels. The primary outcome occurred in 12.0% of the experimental group versus 12.2% of the placebo group (HR 0.99; 95% CI 0.90â1.09; P=0.84) (see Table for components). Gastrointestinal adverse events were seen in 24.7% in the EPA/DHA group versus 14.7% in the placebo group (P<0.001). Atrial fibrillation (AF) was observed in 2.2% and 1.3%, respectively. Prof. Lincoff said, âThe STRENGTH trial showed a 67% increase in AF in the omega-3 treatment group, indicating that there is some uncertainty whether there is net benefit or harm with administration of any omega-3 fatty acid formulation. Given that 2 large clinical trials have now demonstrated a greater incident rate of AF with high-dose omega-3 fatty acid administration, this observation requires further study.â
Table: Results for the primary endpoint, its components, and all-cause death in the STRENGTH trial [1]
- Lincoff AM, et al. STRENGTH Trial: Cardiovascular Outcomes With Omega-3 Carboxylic Acids (Epanova) in Patients With High Vascular Risk and Atherogenic Dyslipidemia. LBS.08, AHA Scientific Sessions 2020, 13â17 Nov.
- Nicholls SJ, et al. JAMA. 2020;324(22)2268-80.
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Table of Contents: AHA 2020
Featured articles
COVID-19 and Influenza
Fewer CV complications than expected in AHA COVID-19 Registry
Worse COVID-19 outcomes in younger obese patients
Effects of CVD in hospitalised COVID-19 patients
Unfavourable outcomes for COVID-19 patients with AF and atrial flutter
High-dose influenza vaccine in patients with CVD
Atrial Fibrillation
Vitamin D or omega 3 fatty acids do not prevent AF
Active screening for AF improves clinical outcomes
AF screening in older adults at primary care visits
CVD Risk Reduction
Clever trial design gets patients back on statins: the SAMSON trial
Polypill plus aspirin reduces cardiovascular events
Lowering LDL cholesterol in older patients is beneficial
No CV benefit from omega 3 in high-risk patients
Safety and efficacy of inclisiran for hypercholesterolemia
Remote risk management programme effective and efficient
Healthy lifestyle lowers mortality irrespective of medication burden
Heart Failure
Omecamtiv mecarbil improves outcomes in HFrEF-patients
IV iron reduces HF hospitalisation
Dapagliflozin reduces renal risk independent of CV disease status
âStrongly consider an SGLT2-inhibitor in most T2DM patientsâ
Additional HFrEF education and patient-engagement tools
Acute Coronary Syndrome
No benefit from omega-3 fatty acids after recent MI
PIONEER III trial: Drug-eluting stents comparable
Coronary and Valve Disease
Extra imaging reveals cause of MINOCA in women
Ticagrelor not superior to clopidogrel after elective PCI
Stroke
Ticagrelor/aspirin reduces stroke risk in patients with ipsilateral cervicocranial plaque
AF monitoring following cardiovascular surgery
Miscellaneous
PAD: Rivaroxaban reduces VTE risk after revascularisation
Sotatercept: potential new treatment option for PAH
Finerenone lowers CV events in diabetic CKD patients
Mavacamten effective in obstructive hypertrophic cardiomyopathy
Children exposed to tobacco smoke have worse heart function as adults
Transgender people have unaddressed heart disease risks
Intensive blood pressure lowering benefits older adults
Longer chest compression pause worsens outcomes after paediatric IHCA
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