Early TAVR beats surveillance in moderate aortic stenosis; AI plaque analysis favored over stress testing; ISCHEMIA-EXTEND finds no survival gain

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read by AI voices · all episodesEarly transcatheter aortic valve replacement cut death or heart failure events to 16.7% from 23.9% versus surveillance in moderate aortic stenosis in the 744-patient PROGRESS trial, presented Nov. 2.
Cleerly said AI-guided coronary CT care was favored over stress testing in PARAMOUNT, ISCHEMIA-EXTEND found no long-term survival gain from routine invasive care, and the Food and Drug Administration (FDA) cleared a PulseAI arrhythmia model for wearables, the company said.
- Research Nov 2, 2026In the PROGRESS trial, 744 patients with moderate aortic stenosis and at-risk features were randomized to transcatheter aortic valve replacement (TAVR) or clinical surveillance. At two years, death from any cause or a heart failure event, the primary end point, occurred in 16.7% with TAVR versus 23.9% with surveillance (risk difference, -7.2 percentage points; 95% CI -13.1 to -1.3; P = .02 for superiority). Death occurred in 8.4% versus 7.3% and heart failure events in 10.8% versus 19.0%. Results were presented Nov. 2 at TCT 2026 and published in the New England Journal of Medicine.
- AI Nov 7, 2026Cleerly said that in PARAMOUNT, an open-label randomized trial at 21 sites, 530 symptomatic outpatients with suspected coronary artery disease were assigned to care guided by AI-based quantitative coronary CT analysis (AI-QCT) or usual care guided by functional stress testing. In a preliminary analysis of 523 patients, AI-QCT care was favored on a prespecified hierarchical composite end point at 180 days (win ratio 2.00, 95% CI 1.37 to 2.56, P < .0001), driven by diagnostic certainty and LDL cholesterol lowering, the company said. The results, presented Nov. 7 at the American Heart Association Scientific Sessions, have not been peer reviewed.
- Research Nov 7, 2026In extended follow-up of the ISCHEMIA trial of more than 5,000 patients with stable coronary disease, 11-year all-cause mortality was 25.8% with an initial invasive strategy and 26.9% with conservative management, a difference that was not significant, according to the JAMA abstract. The analysis recorded 1,071 deaths up to 13 years after enrollment, according to NYU Langone Health. Dr. Judith Hochman, the trial chair, said an invasive approach "is unlikely to help patients live longer." The results were presented Nov. 7 at the American Heart Association Scientific Sessions.Sources: JAMA, NYU Langone Health (PR Newswire)
- AI Nov 5, 2026PulseAI, based in Belfast, Northern Ireland, said Nov. 5 that the Food and Drug Administration (FDA) granted 510(k) clearance for its AI-powered arrhythmia analysis model for wearables, which is designed for integration with compatible ECG devices and software platforms. The company cited a prospective study of 296 participants published in Heart Rhythm that it said showed a 92% reduction in inconclusive interpretations compared with the Apple Watch's native algorithm. That figure measures inconclusive readings; the release gave no sensitivity or specificity figures.Source: PulseAI (PR Newswire)
- Research Nov 7, 2026The phase 3 trial enrolled more than 8,300 adults with established cardiovascular disease and lipoprotein(a) of at least 70 mg/dL, according to the American Heart Association, which reported the results Nov. 7. The primary end point occurred in 12.3% of the pelacarsen group and 12.1% of the placebo group (hazard ratio 1.02; 95% CI 0.9 to 1.15; P = .76), Healio reported. Extended NEJM Evidence analyses by treatment exposure also found no reduction. Developers Ionis and Novartis announced the primary result in September, Healio reported. Dr. Steven Nissen, the senior author, said "it didn't work."
- Research Nov 1, 2026The New England Journal of Medicine published the randomized P4 trial, presented Nov. 1 at TCT 2026, comparing coronary CT angiography (CCTA) with intravascular ultrasound (IVUS) for guiding percutaneous coronary intervention (PCI) in 556 and 549 patients. Target vessel failure at one year, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven revascularization, was 4.1% with CCTA guidance and 4.6% with IVUS guidance, meeting noninferiority (P < .001), according to TCTMD. Median PCI duration was 46 minutes versus 63 minutes, Diagnostic Imaging reported on the study led by Dr. Carlos Collet of the Cardiovascular Research Foundation.
- Research Nov 7, 2026The open-label STREAM trial randomized 1,880 adults 70 or older with at least two chronic conditions and no known cardiovascular disease to stop or continue statins. Two-year restricted mean event-free survival was 96.5 weeks with stopping versus 98.5 weeks with continuing, within the prespecified 5.2-week margin. Over a median 103 weeks, the primary outcome of nonfatal heart attack, nonfatal ischemic stroke or death occurred in 12.7% versus 9.2% (hazard ratio 1.38, 95% CI 1.05 to 1.81). The trial was presented Nov. 7 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine.
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