Daily Cardiology Research Analysis

BACKGROUND: SGLT2 (sodium-glucose cotransporter-2) inhibitors reduce the risk of cardiovascular death or worsening heart failure (HF) in outpatients with HF. Data on initiation in patients hospitalized for HF are limited. METHODS: We conducted a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of in-hospital initiation of dapagliflozin (10 mg daily) in patients hospitalized for HF. The primary efficacy outcome was a composite of time to cardiovascular death or worsening HF through 2 months. Key safety outcomes included symptomatic hypotension and worsening kidney function. A prespecified meta-analysis of randomized trials evaluating initiation of SGLT2 inhibitors in patients hospitalized for HF was performed. RESULTS: Of 2401 patients (median age, 69 [Q1-Q3, 58-77] years, 815 [33.9%] women, 448 [18.7%] Black race, 1717 [71.5%] left ventricular ejection fraction ≤40%, 1074 [44.7%] newly diagnosed HF) randomized between September 2020 and March 2025, 1218 were assigned to dapagliflozin and 1183 to placebo. The primary outcome occurred in 133 patients (10.9%) in the dapagliflozin group and 150 (12.7%) in the placebo group (hazard ratio [HR], 0.86 [95% CI, 0.68-1.08]; CONCLUSIONS: In this trial, in-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening HF through 2 months in hospitalized HF patients. However, the totality of randomized clinical trial data suggests that in-hospital initiation of SGLT2 inhibitors may reduce the early risk of cardiovascular death or worsening HF and of all-cause mortality. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04363697.

BACKGROUND AND AIMS: Limited data suggest a benefit of population-based screening for cardiovascular disease (CVD) with respect to mortality. METHODS: A population-based, parallel-randomized controlled trial of Danish men aged 60-64 years randomized 1:4 to invitation to screening for subclinical CVD or no invitation (control group) were performed. Allocation was based on computer-generated random numbers and stratified on municipality. Only the control group was blinded. The screening included coronary artery calcification score, aneurysms, atrial fibrillation, peripheral arterial disease, hypertension, diabetes mellitus and hypercholesterolemia. Intervention included statin, aspirin and surveillance. The primary outcome was all-cause mortality. RESULTS: 31,268 participants were randomized; 25,322 men in the control arm and 5,946 in the invited arm, of whom 3,720 attended and were screened (62·6%). In intention-to-treat analyses, after a median follow-up of 7·0 years, 555 (9.3%) men in the intervention group and 2,509 (9·9%) men in the control group had died; hazard ratio (HR) = 0.94 (95% CI: 0·86;1·03), p=0·169.Major adverse cardiovascular events (MACE) were registered in 606 (10·2%) versus 2,682 (10·6%) (HR=0·96 [95% CI 0·88;1.04]; p=0·319).Severe bleedings were significantly more common in the invited-to-screening group (6·0% versus 5·1%; HR=1·18 [95% CI 1·05;1·32]; p=0·007). This included intracranial (HR=1·23 (95% CI 0·96;1·58); p=0·097) and gastrointestinal bleedings (HR=1·18; (95% CI 1·03;1·34) p=0·014), respectively. CONCLUSIONS: Invitation to a comprehensive CT-based screening for subclinical CVD did not decrease death over 7 years among men aged 60-64 years but did increase severe bleeding. Because the trial was powered for events over 10 years, further follow-up is needed. Clinicaltrials.gov number: NCT03946410.

BACKGROUND AND AIMS: In the VICTOR trial (NCT05093933), vericiguat was neutral for the primary composite endpoint of cardiovascular death or hospitalization for heart failure (HF). VICTOR was powered to independently assess cardiovascular death. This study reports detailed analysis on the effects of vericiguat on mortality. METHODS: VICTOR, a double-blind, placebo-controlled, randomized trial, enrolled 6105 ambulatory patients with HF and reduced ejection fraction (HFrEF) without recent worsening and randomized them to vericiguat or placebo. The main outcome for this analysis was the prespecified secondary endpoint of cardiovascular death. All-cause death, sudden cardiac death, and death related to HF were also assessed. RESULTS: Over a median of 19.7 months (interquartile range 14.6-25.4), cardiovascular deaths occurred in 292 patients (5.7 deaths per 100 patient-years) and 346 patients (6.8 deaths per 100 patient-years) in the vericiguat and placebo groups, respectively (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.71-0.97; P = 0.020). Risk of death from any cause was lower with vericiguat vs placebo (377 [7.3 deaths per 100 patient-years] vs 440 [8.6 deaths per 100 patient-years]; HR 0.84, 95% CI 0.74-0.97; P = 0.015). Sudden cardiac death and HF-related deaths were lower with vericiguat vs placebo (1.6 vs 2.2 events per 100 patient-years; HR 0.75, 95% CI 0.56-0.99; P = 0.042 and 1.7 vs 2.4 events per 100 patient-years; HR 0.71, 95% CI 0.54-0.94; P = 0.016, respectively). Lower mortality rates were consistent across subgroups including baseline therapy. Consistent cardiovascular and all-cause mortality benefit was seen across baseline N-terminal pro-B-type natriuretic peptide levels. CONCLUSIONS: In ambulatory well-treated participants with HFrEF, vericiguat was associated with clinically meaningful reductions in the key secondary outcome of cardiovascular death, as well as all-cause mortality.