Monthly cardiology bulletin — September 28, 2026

Period covered: August 28 to September 28, 2026. The month was dominated by the European Society of Cardiology Congress (Munich, August 28–31), which concentrated most of the new evidence, with 59 late-breaking trials and four guideline documents. Sixteen items verified at the source were selected; results announced only in press summaries without confirmable figures were discarded. Methods note: in several cases the full text of NEJM, JAMA or Lancet was not accessible, and figures come from official ESC press releases and coverage by TCTMD, PCRonline, ACC.org and EurekAlert, with dates verified there.

Clinical cardiology and prevention

1. 2026 ESC heart failure guidelines: the "mildly reduced" ejection fraction category is gone

[Guideline] [Europe]
Published in the European Heart Journal on August 28, 2026. Main changes: only two ejection fraction categories (reduced, <50%; preserved, ≥50%); "acute" heart failure is renamed "decompensated"; treatment is organized into foundational, additional and interventional therapies; mineralocorticoid receptor antagonists receive a Class I recommendation across all ejection fractions (driven by finerenone); semaglutide and tirzepatide obtain Class IIa in preserved ejection fraction with obesity; and digoxin, mechanical circulatory support and transcatheter mitral repair are upgraded. The same congress released the guidelines on cardiovascular disease and chronic kidney disease (with the ERA), the first standalone cardiac rehabilitation guideline, and the Fifth Universal Definition of Myocardial Infarction.
Why it matters: this is a reorganization of existing evidence rather than new data, but removing the intermediate category and adding incretin therapies will change daily prescribing; in our setting, access to finerenone and semaglutide/tirzepatide remains the real barrier.
https://www.escardio.org/news/press/press-releases/major-changes-made-to-the-esc-guidelines-on-heart-failure/
https://doi.org/10.1093/eurheartj/ehag100

2. STAREE: atorvastatin 40 mg for primary prevention at age 70 and older

[Trial] [Australia]
Randomized, double-blind trial funded by the NHMRC and the Heart Foundation of Australia, presented at ESC on August 29 and published in NEJM. It enrolled 9,971 adults ≥70 years (mean 74.7; 52% women) without cardiovascular disease, diabetes or dementia, randomized to atorvastatin 40 mg or placebo, with a median follow-up of 5.9 years. Major cardiovascular events: 6.0% vs 8.3% (HR 0.70; 95% CI 0.61–0.82; p<0.001), driven mainly by non-fatal events. The other co-primary outcome, disability-free survival, did not change (HR 0.94; 0.84–1.05). More muscle, liver and diabetes adverse events in the active arm; serious adverse events 2.7% in both arms.
Why it matters: it is the largest dedicated statin trial in older adults and closes a guideline gap; the neutral disability result and the benefit concentrated in non-fatal events call for shared decision-making rather than automatic prescribing.
https://www.escardio.org/news/press/press-releases/cholesterol-lowering-medication-reduces-major-cardiovascular-events-by-30-per-cent-in-older-people-without-known-cardiovascular-disease/

3. ACACIA-HCM: aficamten, the first positive drug trial in non-obstructive hypertrophic cardiomyopathy

[Trial] [International, 182 sites]
Double-blind, placebo-controlled trial sponsored by Cytokinetics, presented at ESC on August 28 and published in NEJM. It enrolled 517 symptomatic patients with the non-obstructive form (mean age 55, 54% women, LVEF 68%). At week 36, KCCQ-CSS improved 11.4 vs 8.4 points and peak oxygen uptake +0.64 vs −0.03 mL/kg/min (p=0.003), with improvement in NYHA class and NT-proBNP. LVEF fell below 50% in 10% vs 1%, managed with dose adjustment.
Why it matters: no drug had ever succeeded in this variant, and the result supports a label expansion; but the absolute quality-of-life difference was modest (about 3 points), there are no hard-outcome or durability data, and the sponsor is the manufacturer.
https://cardiovascularbusiness.com/topics/clinical/hypertrophic-cardiomyopathy-hcm/aficamten-shows-potential-be-first-fda-approved-treatment-nonobstructive-hcm
https://www.nejm.org/doi/full/10.1056/NEJMoa2603021

4. LIBREXIA-ACS: milvexian does not reduce events after acute coronary syndrome

[Trial] [Global, 44 countries]
Double-blind trial by BMS and Janssen, presented at ESC on August 29 and published in NEJM: 14,194 patients with acute coronary syndrome within 7 days and ≥2 risk factors, randomized to milvexian 25 mg twice daily (an oral factor XIa inhibitor) or placebo on top of standard antiplatelet therapy; median follow-up 10 months. Cardiovascular death, myocardial infarction or ischemic stroke: 5.4% vs 5.1% (HR 1.05; 95% CI 0.91–1.21; p=0.50). BARC 3c/5 bleeding: 0.3% in both arms. The trial was stopped for futility at an interim analysis.
Why it matters: this is the third consecutive setback for factor XI inhibition in arterial disease; the drug was safe but ineffective in this setting, and the fate of the class now depends on the atrial fibrillation programs (LIBREXIA-AF, LILAC).
https://www.escardio.org/news/press/press-releases/milvexian-did-not-reduce-cardiovascular-events-in-the-librexia-acs-trial/

5. CARDIO-TTRansform: eplontersen misses its primary endpoint in transthyretin amyloid cardiomyopathy

[Trial] [International, 20 countries]
Double-blind trial by AstraZeneca and Ionis, presented at ESC on August 28. It enrolled 1,432 patients with wild-type or hereditary ATTR cardiomyopathy (mean age 72; 57% on a background stabilizer), randomized to eplontersen 45 mg subcutaneously every 4 weeks or placebo for 140 weeks. Composite of cardiovascular mortality and recurrent cardiovascular events: rate ratio 0.89 (95% CI 0.73–1.09; p=0.277). Only a nominal signal of benefit was seen in patients not on a stabilizer.
Why it matters: it contrasts with the positive vutrisiran result in HELIOS-B and suggests that adding an RNA silencer on top of tafamidis or acoramidis provides no demonstrable benefit; the subgroup analysis is hypothesis-generating only.
https://www.escardio.org/news/press/press-releases/eplontersen-trial-did-not-meet-its-primary-endpoint-in-transthyretin-mediated-amyloid-cardiomyopathy/

6. SINGLE-AF: anticoagulation for atrial fibrillation with a single risk factor

[Trial] [South Korea]
Open-label multicenter trial (18 sites; Yonsei, Seoul), funded by the Korean Ministry of Health with support from Samjin and Hanmi, presented at ESC on August 28 and published in NEJM. It enrolled 1,803 patients with atrial fibrillation and a CHA2DS2-VASc score of 1 (men) or 2 (women), randomized to apixaban 5 mg twice daily or rivaroxaban 20 mg daily vs no anticoagulation, for 24 months. Composite of stroke, systemic embolism, major bleeding or cardiovascular death: 0.5% vs 1.5% (HR 0.31; 95% CI 0.10–0.94; p=0.028); ischemic stroke 0.1% vs 1.1%; no difference in major bleeding.
Why it matters: it is the first randomized evidence in the group where guidelines say "may be considered"; but events were very few (wide confidence interval), the trial was open label and enrolled only Korean patients, so it confirms rather than changes practice.
https://www.escardio.org/news/press/press-releases/people-with-atrial-fibrillation-at-intermediate-risk-of-stroke-benefit-from-oral-anticoagulants/

7. TIME-HF: nurse-coordinated, digitally supported collaborative care in heart failure with reduced ejection fraction

[Trial] [India]
Cluster-randomized trial in 22 centers (SCTIMST, Thiruvananthapuram), presented at ESC on August 30 and published in Circulation. It enrolled 1,507 patients with LVEF ≤40% (mean age 62, 32% women, 57% rural), randomized to a nurse-coordinated collaborative care model with a mobile app or to usual care, for 2 years. Hospitalization-free survival 84.0% vs 79.4% (p<0.001); mortality 22% lower (p=0.028); adherence to quadruple therapy 37.3% vs 22.1%.
Why it matters: a low-cost, scalable model with a mortality signal in a resource-limited setting comparable to ours; the unblinded cluster design and the specificity of the Indian health system are the limitations.
https://www.eurekalert.org/news-releases/1141887

Interventional and structural cardiology

8. A-CLOSE: clopidogrel monotherapy vs extended dual antiplatelet therapy after high-risk PCI

[Trial] [South Korea]
Open-label noninferiority trial in 19 centers, investigator-initiated with support from Samjin and Chong Kun Dang, presented at ESC on August 29 and published in NEJM. It enrolled 3,203 patients at high ischemic risk who were event-free 12 months after a drug-eluting stent, randomized to clopidogrel alone or extended dual therapy to 24 months. Net outcome (death, myocardial infarction, stent thrombosis, stroke or BARC 2–5 bleeding): 5.0% vs 5.1% (noninferiority p=0.001). But the ischemic composite was worse with monotherapy (3.7% vs 1.6%; p<0.001), with all-cause death 1.3% vs 0.4%, and BARC 2–5 bleeding was lower (1.8% vs 4.1%; p<0.001).
Why it matters: the "net" result masks a signal of excess ischemic events and death with de-escalation in high-risk patients; it is the first large trial suggesting that extending dual therapy beyond one year may reduce hard events, at a bleeding cost, and only in an East Asian population.
https://www.escardio.org/news/press/press-releases/new-insights-on-the-optimal-duration-of-antiplatelet-therapy-after-stent-implantation/

9. PREMIUM: omitting aspirin at primary PCI for ST-elevation myocardial infarction was worse

[Trial] [Japan]
Open-label noninferiority trial in 69 Japanese centers (Kindai University), funded by Boston Scientific, presented at ESC on August 30 and published in NEJM. It enrolled 2,280 patients with ST-elevation myocardial infarction, randomized to prasugrel monotherapy (20 mg load, then 3.75 mg/day, the Japanese dose) or aspirin plus prasugrel for 12 months. Death, myocardial infarction or stroke: 11.0% vs 8.5% (HR 1.34; 95% CI 1.02–1.75), failing noninferiority; myocardial infarction 2.9% vs 1.3%; BARC 3/5 bleeding lower with monotherapy (5.6% vs 8.4%; HR 0.66).
Why it matters: it is the clearest signal yet that aspirin should not be withdrawn at the time of primary PCI, even with a potent P2Y12 inhibitor; the low Japanese prasugrel dose and near-universal intravascular imaging limit extrapolation, but the safety message is direct for our cath labs.
https://www.escardio.org/news/press/press-releases/is-aspirin-needed-after-a-stemi-heart-attack/
https://www.pcronline.com/News/Congress-coverages/ESC/2026/PREMIUM-Aspirin-omission-at-the-time-of-primary-PCI-in-STEMI

10. TAVI PCI: treating the valve first was noninferior to treating the coronary first

[Trial] [Europe, 48 centers in 6 countries]
Open-label noninferiority trial (University Hospital Zurich, investigator-initiated grant from Edwards), presented at ESC on August 30 and published in NEJM. It enrolled 986 patients with severe aortic stenosis and coronary artery disease (mean age 82, 34% women), randomized to TAVI followed by angiography-guided PCI or PCI followed by TAVI, in staged procedures 1 to 45 days apart. One-year composite (death, myocardial infarction, ischemia-driven revascularization, valve-related heart failure rehospitalization or major bleeding): 22.2% vs 24.2% (difference −2.0 points; 95% CI −7.4 to 3.4; noninferiority p<0.001). Major or life-threatening bleeding 6.6% vs 9.7%, and fewer TAVI-first patients ultimately needed PCI.
Why it matters: it supports treating the valve and then reassessing the real need for angioplasty, with fewer unnecessary PCIs and less bleeding; open label, with the bleeding signal exploratory.
https://www.escardio.org/news/press/press-releases/a-tavi-first-strategy-was-noninferior-to-a-pci-first-strategy-in-patients-with-severe-aortic-stenosis-and-concomitant-coronary-artery-disease/
https://www.nejm.org/doi/full/10.1056/NEJMoa2606924

11. TRIC-I-HF: transcatheter tricuspid repair reduces death and hospitalization

[Trial] [Germany, 29 centers]
Open-label investigator-initiated trial (DZHK and LMU Munich, with an unrestricted grant from Edwards), presented at ESC on August 30 and published in NEJM. It enrolled 360 patients with severe tricuspid regurgitation and heart failure (mean age 80, 56% women, 75% in NYHA class III–IV), randomized to edge-to-edge repair (Pascal 66%, TriClip 33%) plus optimal medical therapy or medical therapy alone. Hierarchical composite of death, heart failure hospitalization and KCCQ at 1 year: win ratio 2.42 (95% CI 1.76–3.33; p<0.0001). Survival free of death or hospitalization 73.9% vs 48.4% at 1 year and 52.4% vs 21.0% at 3 years; mortality HR 0.62 (0.40–0.96); hospitalization HR 0.35 (0.25–0.51).
Why it matters: the first tricuspid trial with a benefit on mortality and hospitalization (TRILUMINATE showed only quality of life); open label, with 48 crossovers, in a very high-risk German population, and with the principal investigator's conflict of interest with Edwards. In our setting, access to these devices remains almost nonexistent.
https://www.tctmd.com/news/tric-i-hf-scores-big-clinical-wins-ttvr-high-risk-patients
https://doi.org/10.1056/NEJMoa2606934

Arrhythmias and electrophysiology

12. PVI-SHAM-AF: atrial fibrillation ablation did not beat a sham procedure on quality of life

[Trial] [Germany and Poland]
The first sham-controlled trial of atrial fibrillation ablation (9 sites; University of Leipzig and Helios), presented at ESC on August 30 and published in The Lancet. It randomized 262 symptomatic patients with paroxysmal or persistent AF 2:1 to pulmonary vein isolation or a sham procedure (sedation and vascular access). Change in the AFEQT score from 0 to 6 months: +19.8 vs +15.7 points (difference 2.6; 95% CI −2.7 to 8.0; p=0.36), no superiority. Freedom from AF at 6 months 73% vs 52%.
Why it matters: the effect on rhythm is confirmed, but at 6 months the symptomatic benefit cannot be distinguished from a placebo effect; small sample, short follow-up and 937 of 1,199 screened patients declined participation (selection bias), yet it forces a rethink of how we justify "symptom-driven" indications.
https://www.escardio.org/news/press/press-releases/catheter-ablation-does-not-improve-quality-of-life-related-to-atrial-fibrillation/

13. IDEAL-AF: individualized low-voltage-zone ablation in persistent atrial fibrillation

[Trial] [Sweden]
Randomized trial in 5 university hospitals with public funding (Swedish Research Council, Heart-Lung Foundation), presented at ESC on August 30 and published in JAMA. It enrolled 209 patients with persistent AF and low-voltage zones, randomized to pulmonary vein isolation plus ablation of those zones or isolation alone. Freedom from atrial arrhythmia at 12 months: 67.6% vs 37.4%, with similar serious adverse events.
Why it matters: it contrasts with previous substrate trials, negative or mixed, and supports selective ablation only in patients with demonstrable substrate; small, single-country sample, and the JAMA full text was not accessible to confirm confidence intervals.
https://news.ki.se/new-method-reduced-recurrence-of-atrial-fibrillation
https://jamanetwork.com/journals/jama/article-abstract/2853398

Cardiac surgery and imaging

14. POET-II: response-guided antibiotic duration in left-sided infective endocarditis

[Trial] [Denmark and Scandinavia]
Randomized trial funded by foundations, presented at ESC on August 28 and published in NEJM. It enrolled 508 patients with left-sided endocarditis (streptococci 57%, S. aureus 24%, E. faecalis 19%; mean age 70), randomized to stopping antibiotics at clinical stabilization (median 26 days) or the standard 4 to 6 weeks (median 41 days). Six-month safety composite (death, unplanned cardiac surgery or symptomatic embolism): 8.2% vs 10.7% (noninferiority p<0.001); days alive without antibiotics 183 vs 169 (p<0.001).
Why it matters: the first randomized trial supporting a roughly two-week shorter course, including surgical patients; there were more relapses with the short regimen (especially with enterococci) and it requires specialized centers with clear stabilization criteria, which cannot be taken for granted in our setting.
https://www.tctmd.com/news/poet-ii-supports-shorter-antibiotic-course-infective-endocarditis

15. LAACS-2: prophylactic surgical left atrial appendage closure without benefit in patients without atrial fibrillation

[Trial] [Denmark, Spain and Sweden]
Randomized trial presented at ESC on August 31 (no simultaneous publication identified). It enrolled 1,500 adults undergoing first-time elective cardiac surgery regardless of atrial fibrillation history (only 4.1% with prior AF; 60% CABG, 30% aortic), randomized to appendage closure or surgery alone. Blindly adjudicated ischemic or hemorrhagic stroke or TIA: 32 vs 38 events (HR 0.85; 95% CI 0.53–1.37; p=0.52).
Why it matters: it argues against routine appendage closure in cardiac surgery patients without atrial fibrillation, in contrast to the LAAOS III benefit in patients with AF; low event rate, crossovers, and complication data still pending.
https://www.pcronline.com/News/Congress-coverages/ESC/2026/LAACS-2-Left-atrial-appendage-closure-with-surgery-2

16. FDA authorizes the first artificial intelligence ECG model for detecting ST-elevation myocardial infarction

[Regulatory FDA] [United States]
De Novo authorization of the Queen of Hearts model (PMcardio, Powerful Medical) to detect ST-elevation myocardial infarction and its equivalents for triage and notification, reported on September 9, 2026. Supporting evidence comprises more than 20 peer-reviewed studies with more than 40,000 patients and a registry across three U.S. networks in which false cath-lab activations fell from 41.8% to 7.9% with the model.
Why it matters: it opens the regulatory pathway for artificial intelligence in acute diagnosis; the evidence is from registries, not randomized trials, but in STEMI networks with non-PCI centers, as in much of the Dominican Republic, the tool is of obvious interest.
https://www.tctmd.com/news/fda-clears-first-ai-ecg-model-acute-mi-detection

Cross-cutting

• Devices and regulatory. The FDA approved the Selution SLR sirolimus-eluting balloon (Cordis) for coronary in-stent restenosis, based on SELUTION4ISR (12-month target lesion failure 16.2% vs 14.5%, noninferior; noninferiority not shown for single-layer restenosis): https://www.tctmd.com/news/fda-approves-selution-slr-drug-eluting-balloon-coronary-stent-restenosis . Abbott obtained FDA approval of the Aveir VR Mini leadless pacemaker, 14% shorter, with no new clinical data: https://cardiacrhythmnews.com/abbott-secures-us-fda-approval-for-aveir-vr-mini-ventricular-leadless-pacemaker/
• China (CRHCP, 7 years). Intensive blood pressure control by non-physician providers in 326 rural villages (33,995 people) reduced all-cause dementia from 10.55% to 8.85% (RR 0.85; 95% CI 0.78–0.91), presented at ESC; no simultaneous publication identified: https://www.escardio.org/news/press/press-releases/long-term-intensive-blood-pressure-control-reduces-dementia-risk/
• Germany (DGK Herztage, September 24–26, Hamburg). The MIRA registry (8 centers; 6,630 TAVI patients with at least moderate mitral or tricuspid regurgitation vs 1,435 without concomitant valve disease) showed 5-year mortality of 66.7% with both lesions vs 42.1% without; registry without etiology or paravalvular leak data, not peer reviewed: https://herzmedizin.de/fuer-aerzte-und-fachpersonal/newsroom/herzerkrankungen/strukturelle/dgk-herztage-2026-mira (source in German)
• Dominican Republic. The Dominican Society of Cardiology took part in the European congress and proposed joint consensus documents with the ACC and ESC on cardiovascular disease and maternal mortality and on emergency chest-pain protocols: https://www.diariodesalud.com.do/texto-diario/mostrar/6003074/sodocardio-fortalece-alianzas-internacionales-congreso-europeo-cardiologia-2026
• Regions with no verifiable news this month: Russia (the National Congress of Cardiologists, September 24–26 in Yekaterinburg, published no accessible results), the Middle East, Argentina, Mexico, Colombia, Chile and Cuba.

Upcoming meetings and dates

• October 8–10: 81st Brazilian Congress of Cardiology together with the World Congress of Cardiology, Rio de Janeiro.
• October 9–12: HFSA Annual Scientific Meeting, Phoenix.
• October 14–16: 52nd Argentine Congress of Cardiology (SAC.26), Buenos Aires.
• October 30 – November 3: 42nd National Cardiology Congress of Turkey.
• October 31 – November 3: TCT 2026, San Diego.
• November 7–9: AHA Scientific Sessions 2026, Chicago.

Monthly cardiology bulletin — September 28, 2026
16 items verified at the source: NEJM, Lancet, JAMA, Circulation and the European Heart Journal, most from the ESC Congress 2026 in Munich.
Three worth your time:
• STAREE: atorvastatin 40 mg in 9,971 adults aged 70+ without cardiovascular disease cut major events from 8.3% to 6.0% (HR 0.70), but did not change disability-free survival.
• PREMIUM (Japan): omitting aspirin at primary PCI for ST-elevation myocardial infarction raised death, MI or stroke from 8.5% to 11.0% (HR 1.34); Japanese prasugrel dose, open label.
• TRIC-I-HF: transcatheter tricuspid repair in 360 patients reduced death and hospitalization (event-free survival 74% vs 48% at one year); open label, supported by Edwards.
Full bulletin, with a critical reading of each study and links to the primary sources:
https://boletinesmedicos.com/en/cardiologia/2026-09-28.html
#Cardiology #HeartFailure #Cardiovascular #ESC2026

Cardiology bulletin 9/28: STAREE, atorvastatin at 70+ cuts major events from 8.3% to 6.0% (HR 0.70); PREMIUM, dropping aspirin at primary PCI in STEMI raises events to 11.0% vs 8.5%. Critical reading and sources: https://boletinesmedicos.com/en/cardiologia/2026-09-28.html