European Heart Journal - Quality of Care and Clinical Outcomes最新文献

Aims: Atrial fibrillation (AF) poses significant risks of stroke and mortality. Catheter ablation (CA) has emerged as a superior rhythm control strategy compared with medical therapy, but its long-term benefits in AF, in ischaemic stroke prevention, remain underexplored.

Methods and results: This observational study analysed data from the TriNetX Research Network, encompassing over 115 million patients. Adults diagnosed with paroxysmal atrial fibrillation (PAF) between 2012 and 2019 were stratified into CA and non-CA groups. Propensity score matching (PSM) accounted for baseline differences in demographics, comorbidities, and medication use. The primary outcome was ischaemic stroke rates at five years, with and without prior ischaemic stroke. Secondary outcomes included all-cause mortality. Kaplan-Meier survival analysis and Cox proportional hazards regression were used to estimate adjusted hazard ratios (HRs). Among 791 013 patients with PAF, 53 178 (6.7%) underwent CA. Post-PSM, ischaemic stroke rates were significantly lower in the CA group (7.96% vs. 9.52%, HR: 0.823, 95% confidence interval, CI: 0.785-0.863, P < 0.0001), even after excluding patients with prior ischaemic stroke (de novo ischaemic stroke) (4.70% vs. 6.43% HR: 0.709, 95% CI: 0.665-0.756, P < 0.0001). All-cause mortality was markedly reduced (9.33% vs. 20.68% HR: 0.388, 95% CI: 0.373-0.404, P < 0.0001).

Conclusion: This large-scale study demonstrates that in PAF patients CA is associated with lower ischaemic stroke rates and all-cause mortality compared with a PSM group without CA. These findings support urgent evaluation of CA in managing PAF and highlight its role in potentially improving survival and reducing stroke risk. Further trials are needed to support these findings.

Background: Renal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting.

Methods and results: We performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting vs. medical therapy in patients with atherosclerotic renal-artery stenosis. Longitudinal growth curve models were used to compare the Physical Symptoms Distress Index (PSDI), SF-36, and EQ-5D scores over time between treatment groups. We also sought to validate the approach of assessing quality of life in hypertension studies. Among 906 patients (mean age 69.2 ± 9.1 years, 49.7% men), symptom frequency and distress due to side effects from antihypertensive medications changed minimally over time, with no significant differences between treatment groups. There were also no clinically significant differences between treatment groups for the SF-36 and its subscales or the EQ-5D. In internal validation of the quality of life measures, the PSDI correlated well with number/type of antihypertensive medications, and generic health status measures correlated with late clinical events.

Conclusions: In a large, multicenter, randomized clinical trial, we found no significant benefit of routine renal-artery stenting over medical management for the treatment of atherosclerotic renal-artery stenosis in terms of disease-specific or generic quality of life measures. As these quality of life measures are important to patients and are associated with medication compliance, future studies of antihypertensive treatments should consider including these quality of life measures as secondary outcomes.

Trial registration: ClinicalTrials.gov: NCT00081731.

Aims: Statins are widely used for the prevention and management of cardiovascular disease (CVD). Women have been shown to be less likely to receive guideline-recommended dose of statins and reach target lipid levels. This study aims to examine sex differences in titration patterns of statin therapy and in the attainment of cholesterol targets in a Dutch healthcare setting.

Methods and results: Data on statin dispensing was extracted from the PHARMO Data Network between 2011 and 2020. New-statin users with at least two recorded statin dispenses were included. Cox proportional hazards models were used to study the association between sex and time to first uptitration of intensity and Poisson regressions were used to estimate sex differences in the attainment of cholesterol targets within 6 and 18 months after statin initiation. We identified 68 150 new users of statin therapy (46% women) with a median age of 65 years [Q1-Q3: 57-72]. The cumulative incidence of uptitration after 3 years of follow-up was 10% in women and 12% in men. After adjustment for age, CVD and other individual characteristics, women were 28% less likely to be uptitrated compared to men (adjusted hazard ratio for women vs. men 0.72 [95% confidence interval (CI) 0.69-0.75]). The adjusted risk ratio of achieving cholesterol target levels within 6 and 18 months after statin initiation in women vs. men were 0.95 (95% CI 0.93-0.97) and 0.98 (95% CI 0.97-0.99).

Conclusion: Among new statin users, women are less likely to be uptitrated compared to men and to achieve cholesterol target levels.

Aims: Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9 mAbs) are recommended for high-risk patients if the low-density lipoprotein cholesterol targets are not achieved with statins and ezetimibe. We studied persistence and adherence to (i) PCSK9 mAbs and (ii) statins and ezetimibe in a nationwide cohort of incident PCSK9 mAb users.

Methods and results: Information on all PCSK9 mAb users ≤80 years from 2015 through 2023 were extracted from the Norwegian Drug Registry. Discontinuation was defined as a gap in treatment ≥180 days and ≥90 days. Adherence was measured as the proportion of days covered during the initial year of PCSK9 mAb therapy. We analysed adherence of statins and ezetimibe before and after PCSK9 mAb initiation. Of 4784 patients initiating PCSK9 mAbs, the median age was 63 years, 41% were female, 61% had atherosclerotic disease, and 34% had familial hypercholesterolaemia. Within 3 years after initiation, 17% experienced a PCSK9 mAb treatment gap exceeding 180 days. In the 12-month period preceding PCSK9 mAb initiation, 74% dispensed statins whereas 67% dispensed ezetimibe. These numbers were reduced to 35% for statins and 42% for ezetimibe during the 12-month period after PCSK9 mAb initiation. Atherosclerotic disease, using ≥3 statins previously, and older age were significantly associated with discontinuation of statins and ezetimibe.

Conclusion: In this high-risk cohort of incident PCSK9 mAb users, more than 1 out of 2 stopped taking statin treatment whereas 40% discontinued ezetimibe. There is a major potential for improving adherence to oral LLD treatment following initiation of PCSK9 mAb.

Aims: To assess the risk of anaemia among low-dose aspirin (LDA) exposure in Danish older individuals in a real-world setting.

Methods and results: Population based-cohort study conducted using Danish registers. The study population included older individuals (≥65 years) exposed to LDA between 2008 and 2013 for primary or secondary prevention of cardiovascular events. Over a 5-year follow-up, outcomes included anaemia incidence based on haemoglobin values and hematinic deficiency incidence based on antianaemic prescriptions. Among the 313 508 individuals included in the study population, those exposed to LDA (n = 59 869, 19.1%) had an incidence of hematinic deficiency determined by the use of antianaemic treatment of 9.6%, with an incidence rate ratio of 9.11 (95% confidence interval, CI: 8.81-9.41) when compared to non-users of LDA (n = 253 639, 80.9%), who had an incidence of 3.7%. Anaemia determined by haemoglobin value measurements was observed in 5.9% of those exposed to LDA, with an incidence rate ratio of 7.89 (95% CI: 7.58-8.21) when compared to non-users of LDA. Approximately, one in five individuals (n = 2 422, 21.5%) who experienced anaemia also experienced bleeding. Severe anaemia was observed in 1.3% of those exposed to LDA compared to 0.6% of those not exposed. Among the exposed, the reduction in haemoglobin and ferritin levels was associated with the severity of anaemia.

Conclusion: These findings indicate that in a real-world setting, anaemia with LDA can occur in 6-10 older individuals out of every 100 LDA users during the first 5 years of treatment.

Aims: To identify comorbidity patterns in elderly Chinese patients with atrial fibrillation (AF), their clinical course, and the effectiveness of the Atrial fibrillation Better Care (ABC) pathway adherence among these phenotypes.

Methods and results: From the ChiOTEAF Registry, we performed a latent class analysis based on 16 cardiovascular (CV) and non-CV conditions. The association between classes of patients, management, and outcomes was evaluated. The primary outcome was a composite of all-cause death and major adverse CV events. We assessed the impact of ABC adherence on outcomes in the whole cohort and among phenotypes. We included 4765 AF patients [median age 77 (68-83) years, 39.1% females]. Four phenotypes were identified: (i) low complexity (48.9%); (ii) atherosclerotic (19.3%); (iii) heart failure (19.4%); and (iv) high complexity (12.3%). During a 1-year follow-up, compared to the 'low complexity' class, the risk of adverse events was higher in 'high complexity' [aOR, 95% confidence interval (CI): 3.20, 2.21-4.66] and 'heart failure' classes (aOR, 95% CI: 1.50, 1.04-2.17). Among 2654 patients [median age 75 (66-81) years, 43.3% females] with available information to assess the ABC pathway, 1094 (41.2%) were adherent. ABC pathway adherence was associated with a lower risk of adverse events (aOR, 95% CI: 0.37, 0.20-0.65). On interaction analysis, its beneficial effect was similar across different clinical phenotypes (Pint = 0.122).

Conclusion: Different clinical phenotypes can be identified in Asian AF patients, with specific patterns of comorbidities and different risks of adverse events. Full ABC pathway adherence was associated with improved outcomes, regardless of the clinical phenotype.

Aims: Hypertrophic cardiomyopathy (HCM) is a common genetic cardiac disorder and a leading cause of sudden cardiac death (SCD). Implantable cardioverter defibrillators (ICDs) are critical for SCD prevention, but risk stratification remains challenging. The aim of this study is to evaluate the predictive performance of conventional risk factors for arrhythmic events in HCM patients with ICDs.

Methods and results: We conducted a systematic search of PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Clinical Trials from inception to November 2024, including studies reporting hazard ratios (HRs) for clinical, electrocardiographic, and imaging predictors of arrhythmic events in ICD recipients with HCM. Pooled HRs were calculated using random-effects model. Twelve studies of 3297 HCM patients with ICDs (91% primary prevention and 9% secondary prevention) were included, with a mean age of 50 years. The annual arrhythmic event rate was 5% [95% confidence interval (CI): 4-7%] during a mean follow-up of 4 years. Significant predictors of arrhythmic events included non-sustained ventricular tachycardia (NSVT) (HR: 2.19, 95% CI: 1.62-2.98), left ventricular ejection fraction (LVEF) <50% (HR: 1.91, 95% CI: 1.27-2.89), intraventricular pressure gradient >30 mmHg (HR: 1.92, 95% CI: 1.03-3.56), and secondary prevention indication (HR: 2.18, 95% CI: 1.39-3.41). Sensitivity analysis in the primary prevention subgroup confirmed NSVT and LVEF <50% as consistently significant predictors, while other traditional risk factors showed limited predictive value.

Conclusion: Specific markers remain strong predictors of arrhythmic events in HCM patients with ICDs, but other traditional risk factors may lack predictive utility.

Aims: In light of recent advances in imaging techniques, molecular understanding and therapeutic options in hypertrophic cardiomyopathy (HCM), we performed a systematic review of current guidelines for the diagnosis and management of HCM in order to identify consensus and discrepant areas in the clinical practice guidelines.

Methods and results: We systematically reviewed the English language guidelines and recommendations for the management of HCM in adults. MEDLINE and EMBASE databases were searched for guidelines published in the last 10 years. Following a systematic search, three guidelines on the diagnosis and management of HCM were identified, all of which were robustly developed (AGREE rigour of development score ≥50%). These guidelines were authored by the major European (European Society of Cardiology; 2023), American (American Heart Association /American College of Cardiology/American Medical Society for Sports Medicine /Heart Rhythm Society/Pediatric and Congenital Electrophysiology Society/Society for Cardiovascular Magnetic Resonance; 2024), and Japanese [Japanese Circulation Society (JCS)/Japanese Heart Failure Society (JHFS); 2018] cardiovascular societies. There was broad consensus on echocardiographic recommendations, the medical and invasive management of HCM, the application of genetic testing and family screening, and exercise and reproductive recommendations in HCM. There were areas of variability in the definition and diagnostic criteria for HCM, cardiovascular magnetic resonance imaging recommendations, and assessment of sudden cardiac death (SCD) risk and prevention strategies. Due to the JCS/JHFS guidelines being older, there are no recommendations on the use of cardiac myosin ATPase inhibitors.

Conclusion: Contemporary guidelines for HCM achieve consensus across a broad range of criteria and recommendations concerning diagnosis and management. However, variations in the approach towards risk assessment for SCD exist between the guidelines. There are also more subtle differences concerning diagnostic criteria and the utility of late gadolinium enhancement for risk stratification, which will likely evolve as the evidence-base broadens.