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- Fröbert, Ole, 1964-, et al.
(författare)
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Influenza Vaccination after Myocardial Infarction : A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
- 2021
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Ingår i: Circulation. - : Lippincott Williams & Wilkins. - 0009-7322 .- 1524-4539. ; 144:18, s. 1476-1484
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Tidskriftsartikel (refereegranskat)abstract
- Background: Observational and small randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease.Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI) (99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary endpoints: all-cause death, cardiovascular death, MI, and stent thrombosis.Results: Due to the Covid-19 pandemic, the data safety and monitoring board decided to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across eight countries; 1290 assigned to influenza vaccine and 1281 to placebo. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72; 95% confidence interval, 0.52 to 0.99; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59; 0.39 to 0.89; P=0.010), of cardiovascular death 2.7% and 4.5%, (hazard ratio, 0.59; 0.39 to 0.90; P=0.014), and of MI 2.0% and 2.4% (hazard ratio, 0.86; 0.50 to 1.46, P=0.57) in the influenza vaccine and placebo groups, respectively. Conclusions: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, as well as a lower risk of all-cause death and cardiovascular death at 12 months compared with placebo.Clinical Trial Registration: URL: http://www.clinicaltrials.gov Unique identifier: NCT02831608.
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| 2. |
- Malmberg, Stephen, et al.
(författare)
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Resting Full-Cycle Ratio versus Fractional Flow Reserve: A SWEDEHEART-Registry-Based Comparison of Two Physiological Indexes for Assessing Coronary Stenosis Severity
- 2023
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Ingår i: Journal of Interventional Cardiology. - : WILEY-HINDAWI. - 0896-4327 .- 1540-8183. ; 2023
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Tidskriftsartikel (refereegranskat)abstract
- The adenosine-requiring physiological index fractional flow reserve (FFR) is the gold-standard method for determining the significance of intermediate lesions, while the resting full-cycle ratio (RFR) is a novel nonhyperaemic index without the need for adenosine administration. The aim of this study was to investigate the degree of concordance between RFR and FFR in indicating the need for revascularisation in patients with intermediate coronary lesions. This was a retrospective, registry-based study utilising data from the SWEDEHEART registry. Patients treated at Ryhov County Hospital in Jonkoping, Sweden, between the 1(st) of January 2020 and the 30(th) of September 2021, were included. The degree of correlation and concordance between RFR and FFR was determined, both when used with a single cut-off (significant stenosis if RFR = 0.89) and with a hybrid approach (significant stenosis if RFR = 0.85, not significant if RFR & GE;0.94, and FFR measurement when RFR was in the grey zone 0.86-0.93). The study population consisted of 143 patients with 200 lesions. The overall correlation between FFR and RFR was significant (r = 0.715, R-2 = 0.511, p = 0.01). A strong correlation was seen for lesions in the left anterior descending artery (LAD) and the left circumflex artery (LCX) (r = 0.748 and 0.742, respectively, both p = 0.01), while the correlation in the right coronary artery (RCA) was moderate (r = 0.524, p = 0.01). The overall concordance between FFR and RFR using a single cut-off was 79.0%. With a hybrid cut-off approach, the degree of concordance was 91%, with no need of adenosine in 50.5% of the lesions. In conclusion, there was a strong correlation and a high degree of concordance between FFR and RFR in determining the significance of a stenosis. The use of a hybrid approach could improve the identification of physiologically significant stenoses while minimising the use of adenosine.
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| 3. |
- Mars, Katarina, et al.
(författare)
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Effects of beta-blockers on quality of life and well-being in patients with myocardial infarction and preserved left ventricular function-a prespecified substudy from REDUCE-AMI
- 2024
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Ingår i: European Heart Journal - Cardiovascular Pharmacotherapy. - : OXFORD UNIV PRESS. - 2055-6837 .- 2055-6845.
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Tidskriftsartikel (refereegranskat)abstract
- Aims In the Randomized Evaluation of Decreased Usage of Beta-Blockers after Acute Myocardial Infarction (REDUCE-AMI) study, long-term beta-blocker use in patients after acute myocardial infarction (AMI) with preserved left ventricular ejection fraction demonstrated no effect on death or cardiovascular outcomes. The aim of this prespecified substudy was to investigate effects of beta-blockers on self-reported quality of life and well-being. Methods and results From this parallel-group, open-label, registry-based randomized clinical trial, EQ-5D, and World Health Organization well-being index-5 (WHO-5) questionnaires were obtained at 6-10 weeks and 11-13 months after AMI in 4080 and 806 patients, respectively. We report results from intention-to-treat and on-treatment analyses for the overall population and relevant subgroups using Wilcoxon rank sum test and adjusted ordinal regression analyses. Of the 4080 individuals reporting EQ-5D (median age 64 years, 22% female), 2023 were randomized to beta-blockers. The main outcome, median EQ-5D index score, was 0.94 [interquartile range (IQR) 0.88, 0.97] in the beta-blocker group, and 0.94 (IQR 0.88, 0.97) in the no-beta-blocker group 6-10 weeks after AMI, OR 1.00 [95% CI 0.89-1.13; P > 0.9]. After 11-13 months, results remained unchanged. Findings were robust in on-treatment analyses and across relevant subgroups. Secondary outcomes, EQ-VAS and WHO-5 index score, confirmed these results. Conclusion Among patients after AMI with preserved left ventricular ejection fraction, self-reported quality of life and well-being was not significantly different in individuals randomized to routine long-term beta-blocker therapy as compared to individuals with no beta-blocker use. These results appear consistent regardless of adherence to randomized treatment and across subgroups which emphasizes the need for a careful individual risk-benefit evaluation prior to initiation of beta-blocker treatment.
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