Dataset Information

Beta-blocker effect on ST-segment: a prespecified analysis of the EARLY-BAMI randomised trial.

ABSTRACT:

Objective

The effect of early intravenous (IV) beta-blockers (BBs) administration in patients undergoing primary percutaneous coronary intervention (pPCI) on ST-segment deviation is unknown. We undertook a prespecified secondary analysis of the Early Beta-blocker Administration before primary PCI in patients with ST-elevation Myocardial Infarction (EARLY-BAMI) trial to investigate the effect of early IV BB on ST-segment deviation.

Methods

The EARLY-BAMI trial randomised patients with ST-elevation myocardial infarction (STEMI) to IV metoprolol (2×5?mg bolus) or matched placebo before pPCI. The prespecified outcome, evaluated by an independent core laboratory blinded to study treatment, was the residual ST-segment deviation 1?hour after pPCI (ie, the percentage of patients with >3?mm cumulative ST deviation at 1?hour after pPCI).

Results

An ECG for the evaluation of residual ST-segment deviation 1?hour after pPCI was available in 442 out of 683 randomised patients. The BB group had a lower heart rate after pPCI compared with placebo (71.2±13.2 vs 74.3±13.6, p=0.016); however, no differences were noted in the percentages of patients with >3?mm cumulative ST deviation at 1?hour after pPCI (58.6% vs 54.1%, p=0.38, in BB vs placebo, respectively) neither a significant difference was found for the percentages of patients in each of the four prespecified groups (normalised ST-segment; 1-3?mm; 4-6?mm;>6?mm residual ST-deviation).

Conclusions

In patients with STEMI, who were being transported for primary PCI, early IV BB administration did not significantly affect ST-segment deviation after pPCI compared with placebo. The neutral result of early IV BB administration on an early marker of pharmacological effect is consistent with the absence of subsequent improvement of clinical outcomes.

SUBMITTER: Fabris E

PROVIDER: S-EPMC7737101 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Beta-blocker effect on ST-segment: a prespecified analysis of the EARLY-BAMI randomised trial.

Fabris Enrico E Hermanides Renicus R Roolvink Vincent V Ibanez Borja B Ottervanger Jan Paul JP Pizarro Gonzalo G van Royen Niels N Mateos-Rodriguez Alonso A Dambrink Jan Henk JH Albarran Agustin A Fernández-Avilés Francisco F Botas Javier J Remkes Wouter W Hernandez-Jaras Victoria V Kedhi Elvin E Zamorano Jose J Alfonso Fernando F García-Lledó Alberto A van Leeuwen Maarten M Nijveldt Robin R Postma Sonja S Kolkman Evelien E Gosselink Marcel M de Smet Bart B Rasoul Saman S Lipsic Erik E Piek Jan J JJ Fuster Valentin V van 't Hof Arnoud Wj AW

Open heart 20201201 2

<h4>Objective</h4>The effect of early intravenous (IV) beta-blockers (BBs) administration in patients undergoing primary percutaneous coronary intervention (pPCI) on ST-segment deviation is unknown. We undertook a prespecified secondary analysis of the Early Beta-blocker Administration before primary PCI in patients with ST-elevation Myocardial Infarction (EARLY-BAMI) trial to investigate the effect of early IV BB on ST-segment deviation.<h4>Methods</h4>The EARLY-BAMI trial randomised patients w ...[more]

PMID: 33318150

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Project description:BackgroundIt is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes.MethodsWe performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy.ResultsA total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups.ConclusionsFetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).

Project description:ObjectiveTo determine if the addition of preventive drug treatment (β blocker), brief behavioural migraine management, or their combination improves the outcome of optimised acute treatment in the management of frequent migraine.DesignRandomised placebo controlled trial over 16 months from July 2001 to November 2005.SettingTwo outpatient sites in Ohio, USA.Participants232 adults (mean age 38 years; 79% female) with diagnosis of migraine with or without aura according to International Headache Society classification of headache disorders criteria, who recorded at least three migraines with disability per 30 days (mean 5.5 migraines/30 days), during an optimised run-in of acute treatment.InterventionsAddition of one of four preventive treatments to optimised acute treatment: β blocker (n=53), matched placebo (n=55), behavioural migraine management plus placebo (n=55), or behavioural migraine management plus β blocker (n=69).Main outcome measureThe primary outcome was change in migraines/30 days; secondary outcomes included change in migraine days/30 days and change in migraine specific quality of life scores.ResultsMixed model analysis showed statistically significant (P≤0.05) differences in outcomes among the four added treatments for both the primary outcome (migraines/30 days) and the two secondary outcomes (change in migraine days/30 days and change in migraine specific quality of life scores). The addition of combined β blocker and behavioural migraine management (-3.3 migraines/30 days, 95% confidence interval -3.2 to -3.5), but not the addition of β blocker alone (-2.1 migraines/30 days, -1.9 to -2.2) or behavioural migraine management alone (-2.2 migraines migraines/30 days, -2.0 to -2.4), improved outcomes compared with optimised acute treatment alone (-2.1 migraines/30 days, -1.9 to -2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined β blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus β blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16.ConclusionThe addition of combined β blocker plus behavioural migraine management, but not the addition of β blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined β blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine.Trial registrationClinical trials NCT00910689.

Project description:ObjectiveTo investigate the association between treatment with an angiotensin receptor blocker and clinical outcomes in patients with ST segment elevation myocardial infarction with preserved left ventricular systolic function.DesignA prospective cohort study using data from a nationwide large scale registry.Setting53 hospitals involved in treatment of acute myocardial infarction in Korea.ParticipantsBetween November 2005 and September 2010, we studied 6698 patients with ST segment elevation myocardial infarction who underwent primary percutaneous coronary intervention and had a left ventricular ejection fraction ≥ 40%.Main outcome measuresCardiac death or myocardial infarction. Patients were divided into an angiotensin receptor blocker group (n=1185), an angiotensin converting enzyme (ACE) inhibitor group (n=4564), and a group who did not receive any renin angiotensin system blocker (n=949). Propensity score matching analysis was also performed.ResultsCardiac death or myocardial infarction occurred in 21 patients (1.8%) in the angiotensin receptor blocker group, 77 patients (1.7%) in the ACE inhibitor group, and 33 patients (3.5%) in the no renin angiotensin system blocker group. After propensity score matching (1175 pairs), there was no significant difference in the rate of cardiac death or myocardial infarction between the angiotensin receptor blocker group and ACE inhibitor group (21 (1.8%) v 23 (2.0%), adjusted hazard ratio 0.65, 95% confidence interval 0.30 to 1.38; P=0.65). The angiotensin receptor blocker group had a lower rate of cardiac death or myocardial infarction than the no renin angiotensin system blocker group in matched populations (803 pairs) (14 (1.7%) v 25 (3.1%), 0.35, 0.14 to 0.90; P=0.03).ConclusionAngiotensin receptor blocker showed beneficial effects comparable with ACE inhibitors in patients with ST segment elevation myocardial infarction with preserved left ventricular systolic function. Angiotensin receptor blockers could be used as an alternative to ACE inhibitors in such patients.

Project description:BackgroundConflicting evidence is available on the efficacy and safety of early intravenous beta-blockers before primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. We performed a patient-pooled meta-analysis of trials comparing early intravenous beta-blockers with placebo or routine care in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.AimThe aim of this study was to evaluate the clinical and safety outcomes of intravenous beta-blockers in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.MethodsFour randomized trials with a total of 1150 patients were included. The main outcome was one-year death or myocardial infarction. Secondary outcomes included biomarker-based infarct size, left ventricular ejection fraction during follow-up, ventricular tachycardia, and a composite safety outcome (cardiogenic shock, symptomatic bradycardia, or hypotension) during hospitalization.ResultsOne-year death or myocardial infarction was similar among beta-blocker (4.2%) and control patients (4.4%) (hazard ratio: 0.96 (95% confidence interval: 0.53-1.75, p=0.90, I2=0%). No difference was observed in biomarker-based infarct size. One-month left ventricular ejection fraction was similar, but left ventricular ejection fraction at six months was significantly higher in patients treated with early intravenous beta-blockade (52.8% versus 50.0% in the control group, p=0.03). No difference was observed in the composite safety outcome or ventricular tachycardia during hospitalization.ConclusionIn ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention, the administration of early intravenous beta-blockers was safe. However, there was no difference in the main outcome of one-year death or myocardial infarction with early intravenous beta-blockers. A larger clinical trial is warranted to confirm the definitive efficacy of early intravenous beta-blockers.

Dataset Information

Beta-blocker effect on ST-segment: a prespecified analysis of the EARLY-BAMI randomised trial.

Objective

Methods

Results

Conclusions

Publications

Beta-blocker effect on ST-segment: a prespecified analysis of the EARLY-BAMI randomised trial.

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