Daily Cardiology Research Analysis

BACKGROUND: Percutaneous coronary intervention for coronary chronic total occlusion (CTO PCI) is offered for symptom and quality of life improvement, despite the absence of blinded randomized evidence. OBJECTIVES: The aim of this study was to assess the efficacy of CTO PCI in the first randomized, placebo-controlled trial of CTO PCI. METHODS: ORBITA-CTO is a multicenter, randomized, blinded trial comparing CTO PCI with a placebo procedure. Patients had angina attributable to a single-vessel CTO, without bystander coronary disease. Angina symptoms were recorded daily using the ORBITA app. After dual-injection coronary angiography, patients were randomized to either CTO PCI or placebo. Blinding was maintained using auditory isolation and deep conscious sedation. Antianginal medications were stopped at randomization and reintroduced on a patient-initiated protocol. At the 6-month follow-up, assessments were repeated. The primary efficacy outcome was the angina symptom score, an ordinal scale combining the daily symptom burden assessed by the ORBITA app, antianginal use, and over-ride events. Secondary outcomes were symptom and quality of life questionnaires and blinding fidelity. RESULTS: Between October 19, 2021 and October 21, 2025, 50 patients were randomly assigned to CTO PCI (n = 25) or placebo (n = 25). One patient randomized to PCI was withdrawn during the procedure because of a complication. All 50 patients were included in the primary analysis. Compared with placebo, CTO PCI resulted in an immediate and sustained improvement in the angina symptom score (OR: 4.38; 95% credible interval [CrI]: 1.57-12.69; probability of benefit [Pr{Benefit}] = 0.996), arising from a clear reduction in the number of episodes of angina (OR: 4.38; 95% CrI: 1.55-11.78; Pr[Benefit] = 0.997). This resulted in an additional 30.6 days free of angina (95% CrI: 11.1-50.7; Pr[Benefit] >0.999). Improvements were also observed with the Seattle Angina Questionnaire in angina frequency (+10.7; 95% CrI: 1.4-20.2; Pr[Benefit] = 0.988), physical limitation, quality of life, and summary score and Canadian Cardiovascular Society class. Blinding of patients, staff, and researchers was maintained. CONCLUSIONS: In patients with symptomatic single-vessel CTO, CTO PCI improves angina beyond placebo. (A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina [ORBITA-CTO]; NCT05142215).

BACKGROUND: Obesity is increasingly recognized as a critical modifier of outcomes following transcatheter aortic valve replacement (TAVR), predisposing patients to subclinical leaflet thrombosis (SLT), hypo-attenuated leaflet thickening (HALT), and paravalvular leak (PVL). Metabolic inflammation, endothelial dysfunction, and pro-thrombotic states associated with obesity contribute to impaired bioprosthetic valve healing. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated robust metabolic, anti-inflammatory, and vascular protective effects. However, its impact on post-TAVR valve performance has not been previously evaluated. OBJECTIVES: To determine whether tirzepatide therapy initiated before TAVR and continued post-procedure reduces the incidence of HALT and PVL in obese patients undergoing TAVR. METHODS: TAVR-MET was a prospective, randomized, open-label, multicenter trial enrolling obese patients (BMI ≥ 30 kg/m RESULTS: Among 260 randomized patients, tirzepatide therapy significantly reduced HALT incidence (8.4% vs 21.6%, p = 0.002) and ≥ mild PVL (10.7% vs 25.3%, p = 0.006) at 6 months. Tirzepatide was associated with marked reductions in CRP and body weight without an increase in major bleeding. Multivariable analysis identified tirzepatide use, CRP reduction >30%, and BMI <32 kg/m CONCLUSIONS: Metabolic modulation with tirzepatide significantly improves post-TAVR valve healing and hemodynamics in obese patients. These findings introduce a novel cardio-metabolic strategy to reduce structural valve complications following TAVR. TRIAL SUMMARY: TAVR-MET STUDY: The TAVR-MET trial was a prospective, randomized, multicenter study designed to evaluate whether metabolic modulation with tirzepatide, a dual GIP/GLP-1 receptor agonist, could improve bioprosthetic valve outcomes following transcatheter aortic valve replacement (TAVR) in obese patients. Obesity is increasingly recognized as a key determinant of post-TAVR complications, particularly subclinical leaflet thrombosis (HALT) and paravalvular leak (PVL), driven by chronic inflammation, endothelial dysfunction, and a prothrombotic state. Tirzepatide has demonstrated potent weight-reducing, anti-inflammatory, and vascular protective effects, but its role in structural valve outcomes had not previously been explored. The trial enrolled 260 obese patients (BMI ≥ 30 kg/m

BACKGROUND: Late gadolinium enhancement (LGE) cardiovascular magnetic resonance (CMR) is the gold standard for assessing myocardial scar. However, a substantial proportion of patients referred for CMR scar assessment are ultimately found to have no evidence of myocardial scarring. PURPOSE: To develop and evaluate a deep learning (DL) model capable of identifying patients without myocardial scar using cine imaging alone, thereby obviating the need for contrast administration and LGE imaging in these individuals. MATERIALS AND METHODS: We developed a novel spatiotemporal DL architecture to identify patients unlikely to have myocardial scar using contrast-free cine images. The model was trained on short-axis cine images from a consecutive cohort of 3,000 patients (1,753 males; mean age 54 ± 18 years) undergoing CMR for evaluation of known or suspected cardiovascular disease, using 1.5 and 3T scanners from Siemens and GE. External validation was performed in an independent multicenter cohort of 1,792 patients where images were acquired on 1.5T and 3T scanners from Siemens and Philips. The architecture utilizes factorized convolutions to extract spatial and temporal features and incorporates residual attention mechanisms to emphasize features most predictive of scar presence on LGE imaging. To evaluate the incremental value of incorporating temporal information, a second model was developed that excluded the temporal kernel from the DL architecture. Both models were trained and optimized using the same training dataset and were evaluated based on similar internal and external testing cohorts. Model performance in identifying patients without myocardial scar was evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity. RESULTS: The spatiotemporal model had a higher AUC compared to the spatial model in the internal (0.79±0.02 vs. 0.70±0.05, p<0.05, n=500) and external cohort (0.78 vs. 0.64, p<0.001, n=1792). The spatiotemporal model correctly identified 64% and 52% of patients without scar in the internal and external test sets, while maintaining a high sensitivity (86% and 82%). CONCLUSIONS: Incorporating temporal information from cine images using an end-to-end spatiotemporal DL architecture enables non-contrast screening for myocardial scar.