Daily Cardiology Research Analysis

BACKGROUND: In patients with coronary artery disease, diabetes increases the risk of restenosis and adverse cardiovascular events after percutaneous coronary intervention (PCI). The Abluminus DES+ is a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with abluminal and balloon-surface coating intended to enhance drug delivery to the vessel wall. We aimed to compare the efficacy and safety of the Abluminus DES+ SES versus the XIENCE durable-polymer everolimus-eluting stent (EES) in patients with diabetes undergoing PCI. METHODS: ABILITY Diabetes Global was a multicentre, prospective, open-label, randomised controlled trial conducted at 74 sites in 16 countries. Adults (aged ≥18 years) with type 1 or type 2 diabetes undergoing PCI for at least one de novo coronary lesion due to chronic coronary syndrome or non-ST-elevation acute coronary syndrome were eligible. Patients were randomly assigned (1:1) to the Abluminus DES+ SES or the XIENCE EES. Randomisation was stratified by site using a secure web-based system with concealed allocation and randomly varying block sizes (4, 6, and 8). Operators were unmasked to allocation; staff performing clinical follow-up and the independent clinical events committee were masked. For the Abluminus DES+ SES, a balloon inflation time of at least 45 s was recommended to facilitate drug transfer; dual antiplatelet therapy was prescribed to all patients according to clinical guidelines and local practice. The primary hypothesis of the study was the non-inferiority of the Abluminus DES+ SES compared with the XIENCE EES for the two coprimary endpoints at 12 months (in the per-protocol population): ischaemia-driven target-lesion revascularisation (2·8% non-inferiority margin) and target-lesion failure (3·0% margin), defined as a composite of cardiovascular death, target-vessel myocardial infarction, or ischaemia-driven target-lesion revascularisation. Time-to-event analyses were conducted with Kaplan-Meier estimates and Cox proportional hazards models. This trial is registered with ClinicalTrials.gov (NCT04236609) and is complete. FINDINGS: Between June 12, 2020, and Sept 9, 2022, 3032 patients were randomly assigned to the Abluminus DES+ SES (n=1514) or XIENCE EES (n=1518). 2931 (96·7%) of 3032 patients completed follow-up to death or 24-month follow-up. Median age was 68·0 years (IQR 60-74). 879 (29·0%) of 3032 patients were female and 2153 (71·0%) were male. At 12 months, in the per-protocol analysis, the Abluminus DES+ SES did not meet the criteria for non-inferiority for ischaemia-driven target-lesion revascularisation compared with XIENCE EES (67 of 1421 patients [Kaplan-Meier estimate 4·8%, 95% CI 3·9-6·2] vs 30 of 1446 [2·1%, 95% CI 1·6-3·2]; absolute risk difference 2·7%, 95% CI 1·3-4·1; p

IMPORTANCE: Influenza infection poses a substantial risk of severe complications, particularly in older adults and high-risk populations, such as individuals with diabetes. The high-dose inactivated influenza vaccine (HD-IIV) has demonstrated superior efficacy against influenza infection compared with the standard-dose inactivated influenza vaccine (SD-IIV) among adults 65 years or older. However, there is limited evidence on its effectiveness in preventing severe respiratory and cardiovascular outcomes in individuals with diabetes. OBJECTIVE: To investigate the relative vaccine effectiveness (rVE) of HD-IIV vs SD-IIV against severe respiratory and cardiovascular outcomes according to diabetes status and across diabetes subgroups. DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified secondary analysis of DANFLU-2, a pragmatic, open-label, individually randomized clinical trial conducted in Denmark during the 2022/2023 to 2024/2025 influenza seasons. Adults 65 years or older were eligible for inclusion regardless of comorbidities. Data were obtained from nationwide health registries and analyzed from June to October 2025. INTERVENTIONS: Participants were randomly allocated 1:1 to receive HD-IIV or SD-IIV. MAIN OUTCOMES AND MEASURES: Outcomes included respiratory and cardiovascular hospitalizations. The potential effect modification by diabetes status and across diabetes subgroups was tested. RESULTS: Among 332 438 participants (mean [SD] age, 73.7 [5.8] years; 161 538 female individuals [48.6%]), 43 881 (13.2%) had diabetes. Overall, HD-IIV compared with SD-IIV was associated with reduced cardiorespiratory hospitalization, cardiovascular hospitalization, and influenza hospitalization. Effect estimates were similar for participants with and without diabetes for cardiorespiratory hospitalization (diabetes: rVE, 7.4%; 95% CI, -2.5% to 16.3%; no diabetes: rVE, 5.3%; 95% CI, 0.4%-10.0%; interaction P = .69), cardiovascular hospitalization (diabetes: rVE, 12.0%; 95% CI, -0.9% to 23.3%; no diabetes: rVE, 6.0%; 95% CI, -0.4% to 12.0%; interaction P = .38), and influenza hospitalization (diabetes: rVE, 41.6%; 95% CI, 5.0%-64.7%, vs no diabetes: rVE, 44.3%; 95% CI, 25.3%-58.7%; interaction P = .87). Duration of diabetes appeared to modify the effect of HD-IIV vs SD-IIV for cardiorespiratory hospitalization, with suggested benefit of HD-IIV in participants with diabetes duration longer than 5 years (rVE, 20.4%; 95% CI, 5.3%-33.1%), but not in those with shorter duration (rVE, -0.4%; 95% CI, -13.8% to 11.5%; interaction P = .03). CONCLUSIONS AND RELEVANCE: The trial results suggest that, among adults 65 years or older, HD-IIV provided consistent benefit for cardiorespiratory, cardiovascular, and influenza hospitalizations compared with SD-IIV, regardless of diabetes status. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05517174.

BACKGROUND: People with HIV (PWH) are at higher risk of myocardial fibrosis and subsequent heart failure (HF) compared to people without HIV (PWOH). Mechanisms underlying this risk and its specificity to PWH are unclear. METHODS: We measured 2594 proteins in plasma obtained concurrently with cardiovascular magnetic resonance imaging among 342 PWH and PWOH. We estimated associations with HIV serostatus and myocardial fibrosis (elevated extracellular volume fraction, ECV ≥30% among women, ≥28% among men) using multivariable regression. Among an independent community-based cohort, we estimated associations between the identified signature and time to incident HF. RESULTS: Participants were age 55±6 years, 25% female, 61% PWH (88% on antiretroviral therapy, 74% undetectable HIV RNA), and 52% had elevated ECV. We identified 39 proteins and one cluster of 42 proteins that were higher among PWH vs. PWOH and positively associated with elevated ECV, independent of risk factors (FDR<0.05). Among an independent cohort of 3223 PWOH (age 68±9 years; 52% female; 118 incident HF cases over 9.8±1.4 years), we found this protein cluster and 34 of 39 individual proteins were associated with time to incident HF. This signature was statistically enriched for T cell activation, TNF signaling, ephrin signaling, and tissue maintenance and repair. CONCLUSION: We identified an HIV-related proteomic signature associated with myocardial fibrosis regardless of HIV serostatus and that predicted incident HF among the general population. Our results identify several novel associations related to specific immune processes that may contribute to risk of myocardial fibrosis and subsequent HF among both PWH and PWOH.