Balcinrenone plus dapagliflozin in patients with heart failure and chronic kidney disease: Results from the phase 2b MIRACLE trial.

AIMS: Many patients with heart failure (HF) have chronic kidney disease (CKD) and may not tolerate mineralocorticoid receptor antagonists. We investigated the efficacy and safety of the novel mineralocorticoid receptor modulator balcinrenone in combination with dapagliflozin in a phase 2b study. METHODS AND RESULTS: From January 2021 to October 2023, we randomized 133 adults with symptomatic HF, ejection fraction <60%, estimated glomerular filtration rate (eGFR) ≥30 to ≤60 ml/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) ≥30 to <3000 mg/g, to receive balcinrenone 15, 50 or 150 mg/day plus dapagliflozin 10 mg/day, or dapagliflozin 10 mg/day plus placebo, for 12 weeks. Enrolment was stopped early because of slow recruitment. Relative reductions in UACR from baseline to week 12 (primary endpoint) were not significantly different between the balcinrenone plus dapagliflozin groups versus dapagliflozin plus placebo. There was no clear balcinrenone dose-response relationship. There were possible dose-dependent increases in serum potassium levels, reduced eGFR in the highest dose group, and non-significant trends towards reduced N-terminal pro-B-type natriuretic peptide levels. Hyperkalaemia adverse events led to discontinuation in two participants receiving balcinrenone plus dapagliflozin and none in those receiving dapagliflozin plus placebo. CONCLUSION: While the smaller than planned sample size limits interpretation, we did not see significant reduction in UACR in patients treated with balcinrenone plus dapagliflozin compared with dapagliflozin plus placebo.

An assessment of the quality of optical coherence tomography image acquisition.

Optical coherence tomography (OCT) provides excellent image resolution, however OCT optimal acquisition is essential but could be challenging owing to several factors. We sought to assess the quality of OCT pullbacks and identify the causes of suboptimal image acquisition. We evaluated 784 (404 pre-PCI; 380 post-PCI) coronary pullbacks from an anonymized OCT database from our Cardiovascular Imaging Core Laboratory. Imaging of the region-of-interest (ROI-lesion or stented segment plus references) was incomplete in 16.1% pullbacks, caused by pullback starting too proximal (63.7%), inappropriate pullback length (17.1%) and pullback starting too distal (11.4%). The quality of image acquisition was excellent in 36.3% pullbacks; whereas 4% pullbacks were unanalyzable. Pullback quality was most commonly affected by poor blood displacement from inadequate contrast volume (27.4%) or flow (25.6%), followed by artifacts (24.1%). Acquisition mode was 'High-Resolution' (54 mm) in 74.4% and 'Survey' (75 mm) in 25.6% of cases. The 54 mm mode was associated with incomplete ROI imaging (p = 0.020) and inadequate contrast volume (p = 0.035). We observed a substantial frequency of suboptimal image acquisition and identified its causes, most of which can be addressed with minor modifications during the procedure, ultimately improving patient outcomes.

Feasibility of coronary angiogram-derived vessel fractional flow reserve in the setting of standard of care percutaneous coronary intervention and its correlation with invasive FFR.

BACKGROUND: Vessel Fractional Flow Reserve (vFFR), a new angiography-derived method for the functional assessment of coronaries, was recently shown to have good correlation with invasive wire-derived FFR, when vFFR-specific image acquisition requirements were followed. We sought to investigate the feasibility of vFFR analysis and its correlation with FFR in the situation where angiography is completed in routine fashion, without intention for virtual analysis. METHODS: Utilizing an anonymized database maintained at our Cardiovascular Imaging Core Laboratory, we included angiographic images from patients that underwent pre- and post-PCI FFR. CAAS Workstation 8.1 software (Pie Medical Imaging) was used for vFFR evaluation. RESULTS: Out of 624 angiograms (312 pre-PCI and 312 post-PCI), vFFR was successfully analyzed in 219 (35.1%) (115 pre-PCI and 104 post-PCI). Reasons for vFFR analysis failure were: <2 angiographic projections (42.5%), table movement while acquisition (25.7%) and resolution incompatibility (15%). From 115 patients with analyzable pre-PCI vFFR, 74 (64.3%) showed agreement with the respective FFR results in terms of positive (≤0.80) vs negative (>0.80) FFR. Pearson's correlation coefficient between them was 0.449 (p < 0.0001). From 104 lesions with analyzable post-PCI vFFR, 94 had availability of FFR, 74 (78.7%) of which showed agreement between the vFFR and FFR. Pearson's correlation between the values was 0.115 (p = 0.2703). CONCLUSION: vFFR could be analyzed in about one-third of previously completed angiographies and a weak correlation was seen between vFFR and FFR. Our results show the importance of following the pre-specified requirements for vFFR analysis. Further studies are needed to validate the software in different settings.