Left bundle branch pacing (LBBP) and left bundle fascicular pacing (LBFP) are conduction system pacing techniques that preserve physiological ventricular activation. Whether proximal or distal capture yields superior electrical or echocardiographic outcomes is uncertain. To systematically evaluate and compare LBFP versus left bundle branch trunk pacing (LBBP) in terms of electrical synchrony and echocardiographic characteristics in patients requiring permanent cardiac pacing. We searched PubMed, Embase, and Cochrane through May 21, 2025, for randomized and observational studies comparing LBFP with LBBP. Outcomes of interest included QRS duration, V6 R-wave peak time (RWPT), left ventricular activation time (LVAT), left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), and pacing thresholds. Statistical analysis was performed using a random-effects model, with heterogeneity assessed using I² statistics. Risk of bias was evaluated using the ROBINS-I. Six studies involving 2,989 patients (1,241 LBFP; 249 LBBP) were included. There were 3 prospective studies, 2 retrospective, and 1 that was both prospective and retrospective. There were no RCTs on this subject. LBFP was associated with a statistically shorter V6-RWPT (mean difference: − 3.50 ms; 95
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; pnon-inferiority=0·44) and target lesion failure (137 [9·7%, 8·4-11·5] vs 89 [6·2%, 5·3-7·8]; 3·5%, 1·5-5·5; pnon-inferiority=0·68). For both endpoints, the lower bound of the 95% CI for the absolute risk difference excluded zero. Target-vessel myocardial infarction occurred more frequently in the Abluminus DES+ SES group (73 of 1421 patients [Kaplan-Meier estimate 5·2%, 95% CI 4·1-6·5] vs 44 of 1446 patients [3·1%, 2·4-4·3]) but there were no significant differences in cardiovascular death (41 of 1421 patients [2·9%, 2·1-3·9] vs 30 of 1446 patients [2·1%, 1·5-3·0]) and all-cause death (52 of 1421 patients [3·7%, 2·8-4·8] vs 48 of 1446 patients [3·3%, 2·5-4·4]). Results were consistent at 24 months in the intention-to-treat analysis, however no significant differences were observed between the two groups in landmark analyses between 12 and 24 months. INTERPRETATION:In patients with diabetes undergoing PCI, the Abluminus DES+ SES was not non-inferior to the XIENCE EES, resulting in higher rates of ischaemia-driven target-lesion revascularisation and target lesion failure at 12-month follow-up. Event rates between 12 and 24 months were similar between groups. These findings highlight the persistent challenge of optimising outcomes in patients with diabetes and underscore the need for continued innovation in stent design and adjunctive pharmacotherapy to reduce residual ischaemic risk in this population. FUNDING:Concept Medical.
Importance:The efficacy and safety of guideline-recommended treatments for heart failure (HF) are uncertain in patients with Chagas disease. Objective:To evaluate the efficacy and safety of the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan in patients with HF with reduced ejection fraction due to Chagas disease. Design, Setting, and Participants:From December 10, 2019, through September 13, 2023, patients with HF, confirmed diagnosis of Chagas disease, left ventricular ejection fraction of 40% or less, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) of 600 pg/mL or greater (or B-type natriuretic peptide [BNP] ≥150 pg/mL) or 400 pg/mL or greater (or BNP ≥100 pg/mL) if hospitalized for HF within the previous 12 months were screened at 83 sites in Argentina, Brazil, Colombia, and Mexico. Statistical analysis was conducted between May and July 2025. Interventions:Patients were randomized to receive sacubitril/valsartan (target dose, 200 mg twice daily) or enalapril (target dose, 10 mg twice daily), in addition to standard therapy. Main Outcomes and Measures:The primary end point was a hierarchical composite outcome tested, in order, of death from cardiovascular causes, hospitalization for HF, or relative change in NT-proBNP from baseline to 12 weeks. The primary analysis was done using a win ratio approach. Results:Overall, 462 participants were randomized to receive sacubitril/valsartan and 460 to receive enalapril (mean [SD] age, 64.2 [10.8] years; 387 [42.0%] were female). Over a median (IQR) follow-up of 25.2 (18.4-33.2) months, cardiovascular death occurred in 110 patients (23.8% [18.3% wins in the hierarchical comparison]) in the sacubitril/valsartan group and 117 patients (25.4% [17.5% wins]) in the enalapril group. A total of 102 patients (22.1% [7.7% wins]) in the sacubitril/valsartan group and 111 (24.1% [6.9% wins]) in the enalapril group experienced a first hospitalization for HF. Patients in the sacubitril/valsartan group had a median (IQR) decrease in NT-proBNP of 30.6% (-54.3% to -0.9%) at 12 weeks, leading to 22.5% wins, while those in the enalapril group had a 5.5% (-31.9% to 37.5%) decrease (7.2% wins). The resulting stratified win ratio was 1.52 (95% CI, 1.28-1.82; P < .001) for sacubitril/valsartan compared with enalapril. Conclusions and Relevance:In patients with HF with reduced ejection fraction due to Chagas disease, there was no significant difference in clinical outcomes between sacubitril/valsartan and enalapril, but there was a greater reduction in NT-proBNP at 12 weeks in patients in the sacubitril/valsartan group. Trial Registration:ClinicalTrials.gov Identifier: NCT04023227.
