OBJECTIVE:This prespecified analysis of Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) evaluated the efficacy of the PCSK9 inhibitor evolocumab for preventing first cardiovascular events in patients with high-risk diabetes. RESEARCH DESIGN AND METHODS:VESALIUS-CV randomized patients with high-risk diabetes (microvascular disease, insulin use, or duration ≥10 years) or qualifying atherosclerosis, but no prior myocardial infarction (MI) or stroke, and LDL cholesterol (LDL-C) ≥90 mg/dL to evolocumab 140 mg or matching placebo every 2 weeks. The dual primary end points were a composite of coronary heart disease death, MI or ischemic stroke (three-point major adverse cardiovascular event [3P-MACE]) and 3P-MACE plus ischemia-driven arterial revascularization (four-point [4P]-MACE). RESULTS:Of the 6,002 patients with high-risk diabetes, 67% were on a high-intensity statin and 24% were on a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) at baseline. The median LDL-C at 48 weeks was 47 mg/dL and 109 mg/dL in the evolocumab and placebo arms, respectively (P < 0.0001). After a median follow-up of 4.6 years, evolocumab decreased the relative rates of 3P-MACE and 4P-MACE by 29% (hazard ratio [HR] 0.71; 95% CI 0.59, 0.86; P = 0.0004) and 21% (HR 0.79; 95% CI 0.69, 0.91; P = 0.0013), respectively. These findings were consistent regardless of the presence or absence of qualifying atherosclerosis, baseline LDL-C, statin intensity, and SGLT2i or GLP-1RA use (Pint > 0.05 for each). The porportion of patients with all-cause death was 8.8% vs. 11.0% in the evolocumab versus placebo arms (HR 0.79; 95% CI 0.67, 0.93). CONCLUSIONS:Evolocumab reduced the rate of cardiovascular events in patients with high-risk diabetes, regardless of the presence or absence of qualifying atherosclerosis and background use of other cardioprotective agents.
We aimed to develop and assess the performance of a Machine learning (ML) model integrating common clinical features to predict arrhythmic events in patients with Hypertrophic Cardiomyopathy (HCM). Post-hoc analysis of an international multicenter registry of 531 HCM patients (49 years (IQR 35–61), 57
Purpose: Patients with severe aortic stenosis (AS) present a high but heterogeneous risk of adverse outcomes. Although risk stratification relies primarily on clinical scores, myocardial fibrosis assessed by computed tomography–derived extracellular volume (ECV-CT) has emerged as a potential prognostic marker. This study aimed to determine whether ECV-CT provides independent and incremental prognostic value beyond established clinical risk scores in patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) planning. Methods: In this single-centre prospective study, consecutive patients with severe AS referred for TAVR planning computed tomography were included. ECV-CT was quantified from pre- and post-contrast images by calculating the ratio of attenuation change in the interventricular septum to that in the left ventricular blood pool. Prognostic performance was compared with EuroSCORE II and PRIORiTize-TAVI. The primary endpoint was a composite of all-cause mortality or cardiovascular hospitalization. Results: A total of 316 patients (mean age 81 ± 8 years; 44
Purpose The TAFA-CRUZ study evaluated the real-world effectiveness and safety of tafamidis 61 mg in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure. The primary objective was to evaluate all-cause mortality, with key secondary outcomes including 30-month survival, cardiovascular-related deaths, and safety. Methods This prospective, single-center observational study included 238 patients with ATTR-CM followed between 2019 and 2024 in a structured amyloidosis program. Of these patients, 140 were initiated on tafamidis 61 mg in additional to receiving supportive care guided by the CHAD-STOP strategy, while 98 received only supportive care. Baseline demographics, outcomes, and subgroup analyses, including National Amyloidosis Centre (NAC) stages, were assessed. Results The cohort was predominantly elderly (mean age, 81.8 years) and male (80.7%). Patients treated with tafamidis were, on average, younger and less symptomatic at baseline than those in the comparator group. After a median follow-up of 21 months, treatment with tafamidis, as compared to supportive care alone, was associated with lower all-cause mortality (16.4% vs 54.1%) and cardiovascular mortality (13.6% vs 39.8%). Thirty-month survival was significantly higher in the tafamidis group (92.1% vs 51.0%; hazard ratio [HR], 0.17 [95% CI, 0.10-0.32]; P < 0.001). Survival benefits were consistent across all NAC stages, with the greatest relative effect observed in NAC stage 3. Tafamidis was well tolerated, with adverse events mostly limited to mild transient gastrointestinal symptoms and rare treatment discontinuations. Conclusion In this real-world cohort, treatment with tafamidis 61 mg was effective and safe, being associated with significantly reduced all-cause and cardiovascular mortality across all disease stages. These findings extend clinical trial evidence into routine practice and highlight the value of specialized amyloidosis programs in optimizing outcomes for patients with ATTR-CM.
