Introduction and objectives: Autoimmune diseases (ADs) are associated with an increased risk of developing certain cardiac arrhythmias. However, their prognostic effect in patients with cardiac arrhythmias has not been comprehensively investigated. We aimed to assess the association between ADs and prognosis in this population.
Methods: Based on a large retrospective observational cohort, this study included patients with various cardiac arrhythmias, including atrial fibrillation/atrial flutter (AF/AFl), ventricular tachycardia/ventricular fibrillation (VT/VF), and bradyarrhythmias. ADs were considered an exposure factor. The endpoint was all-cause mortality. Cox proportional hazards regression analyses were performed to calculate hazard ratios (HR) and 95% confidence intervals (95%CI) to quantify associations. Propensity score matching was used to mitigate potential confounding bias.
Results: The analysis included 14 225 patients (mean age, 73.9±12.5 years, 59.2% women), of whom 4552 (32.0%) died within 1 year of discharge. After adjustment for various covariates, patients with ADs showed a higher risk of mortality in AF/AFl (HR, 1.23; 95%CI, 1.1-1.33; P<.001) and VT/VF (HR, 1.28; 95%CI, 1.02-1.60, P=.032). For bradyarrhythmias, although a potential association was observed, the trend did not reach statistical significance (HR, 1.20; 95%CI, 0.93-1.56; P=.168). The association persisted among multiple sensitivity analyses and remained consistent after adjustment for a wide range of covariates.
Conclusions: ADs were significantly associated with an increased risk of all-cause mortality in patients with cardiac arrhythmias, particularly in those with AF/AFl and VT/VF.
Introduction y objectives: Tako-tsubo syndrome (TTS) is a cardiac condition that mimics acute coronary syndrome, characterized by transient left ventricular dysfunction in the absence of culprit coronary artery stenosis. Although its etiology remains unknown, reversible microvascular dysfunction secondary to an adrenergic surge is thought to play a role. Treatment is empirical, although most patients receive beta-blockers (BB) in clinical practice. The Beta-blockers in Tako-tsubo Syndrome study (β-Tako), is an academic, multicenter, pragmatic, prospective randomized open-label trial with blinded endpoint evaluation that aims to assess the efficacy and safety of BB in patients with TTS.
Methods: The diagnosis of TTS will be confirmed by invasive coronary angiography and serial echocardiographic assessments. Two hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm.
Results: The primary efficacy endpoint is the comparison of the wall motion score index by echocardiography at 7 days, analyzed by an independent core laboratory. Changes in left ventricular ejection fraction and global longitudinal strain will also be evaluated. A composite clinical endpoint (death, stroke, admission for recurrent TTS, acute coronary syndrome, heart failure, or atrial fibrillation) at 1 year will be assessed by an independent clinical events committee. Several predefined substudies will be conducted to examine clinical, imaging, biomarker, pharmacogenetic, inflammatory, messenger ribonucleic acids, and quality-of-life parameters.
Conclusions: The β-Tako trial will generate robust scientific evidence to address unmet clinical needs and inform clinical and treatment decisions in this uniquely challenging clinical entity. The study has been registered (EU-CT number: 2023-510213-25-01, ClinicalTrials.gov Identifier, NCT06509074.