Clinical Research in Cardiology最新文献

Background: High-sensitivity cardiac troponin (hs-cTn) assays are the gold standard for the early diagnosis and risk stratification of acute myocardial infarction (AMI). PERFORM-TSIX (clinicaltrials.gov identifier: NCT06734117) is a prospective, international, observational, longitudinal cohort study to evaluate the clinical performance of the next-generation Elecsys® Troponin T hs Gen 6 assay; the study design is presented here.

Objectives: The primary objective is to determine the sensitivity of the Troponin T hs Gen 6 assay for the detection of centrally adjudicated AMI diagnosis at 3 h post-emergency department (ED) presentation. Secondary objectives include evaluation of clinical performance at 0, 1-, 5-, and 6-h post-ED presentation and validation of thresholds for a 0/1-h algorithm to rule out AMI. Exploratory objectives include validation of thresholds for a 0/1-h algorithm to rule in AMI and a 0/2-h algorithm to rule in/out AMI and evaluation of prognostic performance at 30 and 180 days.

Methods: PERFORM-TSIX enrolled 5631 participants across 50 sites from the USA, Europe, China, and Japan. Patients aged ≥ 20 years presenting to the ED with symptoms/signs of acute coronary syndrome were enrolled. All patients were required to have cTn measured as part of their routine care; AMI diagnosis was adjudicated by an independent clinical events committee in accordance with the Fourth Universal Definition of MI, blinded to the results of the Troponin T hs Gen 6 assay.

Conclusion: PERFORM-TSIX will determine the clinical performance of the Troponin T hs Gen 6 assay for the diagnosis of AMI in a large, diverse global population.

Background: The prognostic benefit of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in stable coronary artery disease (CAD) remains uncertain.

Objectives: To evaluate long-term survival following CTO PCI compared with medical therapy (MT) using target trial emulation and a nationwide real-world registry.

Methods: We included 7813 patients with stable CAD and a documented CTO from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) between 2015 and 2024. CTO PCI was modeled as a time-dependent exposure. The primary outcome was all-cause mortality. We used inverse probability of treatment weighting (IPTW), time-dependent Cox regression, and instrumental variable (IV) analysis to adjust for confounding.

Results: Over a median follow-up of 5.08 years, 1253 deaths occurred. While unadjusted survival favored CTO PCI (HR 0.74; 95% CI, 0.64-0.86; p < 0.001), IPTW and IV adjustment showed no significant reduction in mortality compared with MT (IPTW HR 0.94; 95% CI, 0.80-1.10; p = 0.41; IV HR 1.00; 95% CI, 0.71-1.40; p = 0.999). Successful CTO PCI was associated with improved survival (HR 0.74; 95% CI, 0.62-0.87), whereas unsuccessful procedures were not (HR 1.08; 95% CI, 0.79-1.47). Subgroup analyses showed no consistent benefit, although a modest survival advantage was observed in non-diabetic patients.

Conclusions: In this large nationwide study using target trial emulation, CTO PCI was not associated with improved overall survival compared with MT. Only successful procedures conferred a benefit, highlighting the importance of procedural success and patient selection in CTO revascularization strategies.

Background and objective: Related to ongoing demographic, the number of patients with cardiac and non-cardiac comorbidities increases. Heart failure with mildly reduced ejection fraction (HFmrEF) represents a heterogeneous population with diverse clinical profiles. The study investigates the prevalence and prognostic impact of multimorbidity in patients hospitalized with HFmrEF.

Methods: Consecutive patients with HFmrEF were retrospectively included at one institution from 2016 to 2022 and divided into four groups based on the number of concomitant comorbidities taking into account 12 comorbidities (i.e., 0-1, 2-3, 4-5, ≥ 6 comorbidities). The prognostic impact of the number of comorbidities was investigated with regard to the primary endpoint all-cause mortality at 30 months.

Results: From 2,184 patients hospitalized with HFmrEF, 37% presented with 4-5 comorbidities, 17% with ≥ 6 comorbidities. Compared to patients with 4-5, 2-3, 0-1 comorbidities, patients with ≥ 6 comorbidities were more frequently discharged with beta-blockers (83.6% vs. 78.7% vs. 77.6% vs. 64.7%; p = 0.001) and mineralocorticoid receptor antagonists (MRA) (17.2% vs. 15.7% vs. 12.8% vs. 7.9%; p = 0.004). The risk of all-cause mortality at 30 months was higher in patients with ≥ 6 comorbidities compared to patients with less comorbidities (i.e., 4-5, 2-3, 0-1) (59.5% vs. 38.6% vs. 17.0% vs. 7.9%, p = 0.001). Both cardiovascular (HR = 1.106; 95% CI 1.030 - 1.188; p = 0.006) and non-cardiovascular (HR = 1.564; 95% CI 1.470 - 1.664; p = 0.001) comorbidities predicted the risk of long-term all-cause mortality.

Conclusion: In patients hospitalized with HFmrEF, more than 50% had at least 4 comorbidities. Both cardiovascular and non-cardiovascular comorbidities predicted the risk of long-term all-cause mortality in HFmrEF.

Aims: Metabolic dysfunction-associated steatotic liver disease (MASLD) and cardiometabolic multimorbidity (CMM) are growing public health concerns. However, the impact of MASLD on single cardiometabolic disease (CMD), CMM, and mortality remains unclear.

Methods: This prospective analysis used data from the UK Biobank, involving 376,087 participants aged 37-73 years. CMM was defined as the coexistence of at least two CMDs, including stroke, ischemic heart disease (IHD), and type 2 diabetes (T2D). MASLD severity was evaluated using liver fibrosis scores. Multivariable Cox proportional hazards model was used to investigate the associations. Structural equation modeling was employed to determine the extent to which CMD or CMM mediated the relationship between MASLD and death.

Results: Over a median follow-up of 11.7 years, MASLD was linked to significantly higher risks of single CMD (HR 1.94, 95% CI 1.92-1.96), CMM (HR 3.40, 95% CI 3.31-3.49), and all-cause mortality (HR 1.21, 95% CI 1.20-1.23) in CMD-free participants. Additionally, MASLD increased the risk of progression from single CMD to CMM (HR 1.95, 95% CI 1.81-2.10) and to all-cause mortality (HR 1.11, 95% CI 1.03-1.20). However, MASLD was not independently associated with transitions from CMM to mortality (HR 1.06, 95% CI 0.89-1.28). Furthermore, these risks escalated with increasing MASLD severity. CMD mediated 44.5% of the indirect effect of MASLD on mortality, and CMM mediated 32.5% of this effect.

Conclusion: MASLD is associated with the increased risk of CMD, CMM, and mortality. Preventing and managing MASLD may reduce the incidence of CMD, CMM, and associated mortality.

Background: Full post-mortem examinations (conventional autopsies) are a valuable tool for understanding disease mechanisms but are commonly rare, especially in epidemiological research. This study aimed to (1) assess conventional autopsy implementation in the Hamburg City Health Study (HCHS), (2) identify factors associated with conventional autopsy performance, and (3) compare conventional autopsy findings with presumed (clinical) causes of death.

Methods: We assessed the implementation of conventional autopsies and the collection of related data within the HCHS, a population-based cohort of 16,411 individuals aged 45-74, enrolled since 2016. Conventional autopsy data were obtained through death and autopsy certificates over an up to 7-year follow-up period (spring 2016 to spring 2023). Descriptive analyses were performed, including baseline characteristics and causes of death.

Results: During a median follow-up of 4.33 years, 354 participants (2.3% of the cohort) died. Death certificates were available for 275 cases, and 23 individuals underwent conventional autopsy (autopsy rate: 6.5%). In 10 cases (43.5%), the conventional autopsy confirmed the hypothesized cause of death, while in four cases (17.4%), there was a discrepancy or ambiguity between the death certificate and conventional autopsy findings. In the remaining nine cases (39.1%), no evident causal chain could be established based on external examination alone, which constituted the reason for conventional autopsy. Factors associated with a higher likelihood of conventional autopsy included unknown or non-natural causes of death (as judicial autopsy order) and prolonged hospitalization prior to death.

Conclusion: Conducting systematic conventional autopsies in large, population-based cohorts is feasible but presents logistical and ethical challenges. Conventional autopsies often confirmed clinical diagnoses. Still, relevant discrepancies and ambiguities remained, in which conventional autopsy findings added relevant information for crucial clarification. Incorporating conventional autopsy findings enhances the accuracy of mortality data and strengthens epidemiological outcome assessments.

Background: The German National Care Guideline for chronic coronary syndromes (CCS) and the European Society of Cardiology (ESC) guidelines on the management of CCS recommend coronary artery bypass grafting (CABG) for patients with diabetes and multivessel coronary artery disease (MVD). There are limited data on how these recommendations are followed in routine clinical practice.

Methods: Consecutive patients with CCS who underwent diagnostic coronary angiography (CA) between 2009 and 2020 were prospectively enrolled within the German CA registry by the "Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte" (ALKK). Patients with acute coronary syndromes were excluded.

Results: A total of 245,555 patients without prior CABG undergoing CA for CCS were included. In patients with 3-vessel disease, PCI was recommended in 62.2% of diabetics versus 63.8% of non-diabetics, CABG in 19.4% versus 18.8%, and conservative treatment in 18.4% versus 17.4%. In multivariable analysis, 3-vessel disease (odds ratio (OR) 4.01, 95% confidence interval (CI), 2.72-5.92) and left main disease (OR 14.64, 95% CI, 10.51-12.40) emerged as the strongest predictors for recommending CABG, whereas the presence of diabetes had no significant influence (OR 1.09, 95% CI, 0.98-1.21).

Conclusion: In real-world clinical practice, PCI remains the predominant revascularization strategy for MVD in patients with diabetes and CCS. Coronary anatomy, rather than diabetic status, is the principal determinant for the decision for CABG. These findings contrast with the recommendations in current national and international revascularization guidelines.

Aim: Atrial fibrillation (AF) is a major cause of stroke and thromboembolic events. We aimed to assess whether, in patients with AF, rate or rhythm control strategies reduce the risk for stroke or cardiovascular events.

Methods and results: Randomized controlled trials (RCTs) comparing rate control versus rhythm control strategies were systematically searched and included in a network meta-analysis (NMA). Co-primary outcomes were stroke within 1 year and stroke beyond 1 year from randomization. Twenty-one RCTs (35,447 patients) were included in the analyses. When stroke occurring any time after randomization was considered, antiarrhythmic drugs (AAD-Alone) had lower risk (OR 0.35, 95% CI 0.15-0.80), AAD plus electrical cardioversion had higher risk (OR 4.01, 95% CI 1.32-12.13), while AAD plus rate control and ablation had similar risks, all in comparison to rate control. These differences disappeared in studies with use of anticoagulation ≥ 70% of patients. No differences were observed between rate control and individual rhythm control strategies concerning the risk for stroke within 1 year (seven studies; 19,339 patients) and beyond 1 year (10 studies; 10,325 patients). Ablation reduced the risk of heart failure hospitalization (OR 0.38, 95% CI 0.17-0.85).

Conclusions: In patients with AF, the benefit of rhythm control over rate control for prevention of stroke disappears with appropriate anticoagulation. Catheter ablation reduces hospitalizations for heart failure compared to rate control. Rhythm control may offer benefits beyond stroke prevention, supporting a personalized treatment approach.

Background: Timing for anticoagulation (AC) initiation in atrial fibrillation (AF) after ischemic stroke (IS) remains uncertain. Previous large studies mostly represented high-income countries, with limited representation of severe stroke and low rates of primary outcomes. We aimed to compare AC initiation at different timeframes in a broader and more diverse population.

Methods: We searched Medline, Embase, Cochrane, and Clinical Trials for trials and observational studies comparing early versus late AC initiation in AF after IS. The study groups were 0-4, 5-14, and ≥ 15 days. Primary endpoints were recurrent IS only and intracranial hemorrhage (ICH). Secondary endpoints included systemic embolism, all-cause mortality, and major bleeding. Sensitivity analysis focused on studies using direct oral anticoagulants and timing categories consistent with our classification.

Results: Our meta-analysis included 20 studies with 25,884 patients. Mean NIHSS was 6.14, with at least 3204 severe strokes. IS was similar between groups, but the 0-4 days strategy ranked first (P-score = 0.92). Sensitivity analysis showed reduced recurrent IS in the 0-4 days group versus the ≥ 15 days group (RR, 0.28; 95% CI, 0.12-0.65; P < 0.01). ICH had no difference across all periods, 0-4 days versus 5-14 days (RR, 1.13; 95% CI, 0.58-2.18; P = 0.14); ≥ 15 days versus 5-14 days (RR, 0.91; 95% CI, 0.50 to 1.65; P = 0.75); and 0-4 days versus ≥ 15 days (RR, 0.87; 95% CI, 0.49-1.55; P = 0.63). No differences were observed in all secondary outcomes.

Conclusion: Initiating AC 0-4 days after IS appears safe and may reduce the risk of recurrent stroke without increasing ICH, even in a more diverse population with higher-bleeding risk.

Background and aim: The impact of coronary microvascular dysfunction (CMD) on parameters of systolic and diastolic function, particularly in patients with heart failure and preserved ejection fraction (HFpEF), is poorly understood. Although these conditions often overlap, their combined impact on parameters of systolic and diastolic function remains unexplored.

Methods: Consecutive patients undergoing invasive CMD assessment were enrolled. Systolic function was assessed by global longitudinal strain (GLS), diastolic function by E/E', left atrial reservoir strain (LARS), and non-invasive single-beat pressure-volume relationship stiffness constant (β) estimation.

Results: Of 145 patients, 72 (49.7%) had CMD, 35 (24%) HFpEF, and 23 (16%) both conditions. HFpEF was twice as prevalent in CMD patients as compared to patients without CMD (32% vs. 16%, p = 0.034). Both CMD was associated with parameters of both diastolic (E/E' β = 0.29, p < 0.001, LV stiffness constant β = 0.23; p = 0.006, and LARS β = -0.21, p = 0.02) and systolic function (GLS β = 0.31, p < 0.001). The presence of CMD was associated with an impairment in LV stiffness both in patients with and without HFpEF (p for interaction = 0.044).

Conclusion: HFpEF is highly prevalent in patients with CMD, and CMD is associated with both systolic and diastolic dysfunction. In patients with HFpEF, an additional worsening of diastolic function is observed.