Monthly cardiology bulletin — October 1, 2026

Period covered: September 1 to October 1, 2026. This issue does not repeat the sixteen items of the special bulletin of September 28 (ESC heart failure guidelines, STAREE, ACACIA-HCM, LIBREXIA-ACS, CARDIO-TTRansform, SINGLE-AF, TIME-HF, A-CLOSE, PREMIUM, TAVI PCI, TRIC-I-HF, PVI-SHAM-AF, IDEAL-AF, POET-II, LAACS-2 and the AI electrocardiogram model): it covers what was published in September and the Munich ESC Congress trials that were left out. There are 14 items verified at the source. Method note: the full text of NEJM, JAMA and Lancet was not accessible in several cases; figures come from coverage by TCTMD, Radcliffe Cardiology, ACC.org, HCPLive, Cardiovascular Business and from ESC and manufacturer press releases, with the date checked in each.

Clinical cardiology and prevention

1. Lp(a)HORIZON: pelacarsen does not reduce cardiovascular events

[Industry] [Global]
Novartis announced on September 4, 2026 that the randomized, double-blind phase III trial of pelacarsen (an antisense oligonucleotide against lipoprotein(a)) versus placebo did not meet its primary endpoint: the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent coronary revascularization. It enrolled more than 8,000 patients with established cardiovascular disease and elevated Lp(a) on guideline-directed background therapy. The drug did lower Lp(a); no event figures or effect sizes were released, and full data will be presented at an upcoming congress.
Why it matters: this is the first large outcomes trial of specific Lp(a) lowering, and its negative result casts doubt on the therapeutic hypothesis, though not on Lp(a) as a risk marker; there is only a manufacturer press release, with no data to judge power, duration or subgroups. Olpasiran and lepodisiran are still pending. In practice nothing changes: measure Lp(a) once and treat the remaining risk factors intensively.
https://www.novartis.com/news/media-releases/novartis-announces-lpahorizon-phase-iii-topline-results-pelacarsen-patients-elevated-lpa-and-established-cardiovascular-disease-cvd
https://www.tctmd.com/news/lpahorizon-top-line-results-dash-hopes-pelacarsen

2. TRIUMPH-2: retatrutide in obesity with type 2 diabetes

[Clinical trial] [International, 92 sites in 8 countries]
Double-blind phase 3 trial from Eli Lilly, published in The Lancet on September 29, 2026 and presented at the EASD meeting. It enrolled 1,152 adults with body mass index ≥27 kg/m² and type 2 diabetes (mean BMI 38.2; mean HbA1c 7.71%), randomized to retatrutide 4, 9 or 12 mg weekly or placebo. Weight change at week 80: −11.9%, −16.8% and −18.8% versus −5.1% (p<0.0001 for all three doses); HbA1c down by up to 1.6 points versus 0.2. With 12 mg, systolic pressure fell 10.8 mmHg and triglycerides 39.5%. Adverse events: diarrhea 34%, nausea 28% and dysesthesia 7% at the high dose; discontinuation for adverse events 4–12% versus 5%.
Why it matters: this is the largest weight loss documented in people with diabetes, but there are no cardiovascular outcome data yet, the drug is not approved (Lilly plans to file in 2027), and dysesthesia and hypotension deserve watching; cost will be the barrier in our setting.
https://doi.org/10.1016/S0140-6736(26)01861-1
https://www.pharmacytimes.com/view/retatrutide-cuts-weight-up-to-18-8-in-adults-with-t2d-obesity

3. VESALIUS-CV: evolocumab and all-cause mortality in patients without prior MI or stroke

[Clinical trial, prespecified analysis] [International, 774 sites in 33 countries]
Prespecified analysis published in Circulation on August 31, 2026 and presented at the ESC Congress. The Amgen trial randomized 12,257 high-risk patients without prior myocardial infarction or stroke (median age 66, 43% women) to evolocumab 140 mg every 2 weeks or placebo on top of optimized lipid-lowering therapy, with a median follow-up of 4.6 years. There were 434 versus 539 deaths (5-year estimate 7.9% versus 9.7%; HR 0.80; 95% CI 0.70–0.91; p=0.0005, nominal). The benefit was absent in the first 18 months (HR 0.99) and present thereafter (HR 0.73; 0.63–0.85).
Why it matters: this is the first signal of lower all-cause mortality with a PCSK9 inhibitor in patients without a prior event, but it is a secondary endpoint with nominal significance, late onset, and a manufacturer-run trial; it supports intensive LDL lowering and does not by itself mandate the antibody, whose cost remains prohibitive here.
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.126.082436
https://www.hcplive.com/view/evolocumab-improves-survival-in-patients-without-prior-mi-or-stroke

4. ENRICH-AF: edoxaban after intracranial hemorrhage did not prevent stroke and increased bleeding

[Clinical trial] [International, 174 sites in 20 countries]
Investigator-initiated, open-label, blinded-endpoint trial (PHRI, McMaster University), presented at the ESC Congress in late August; no journal publication identified. It enrolled 948 patients with atrial fibrillation who had survived an intracranial hemorrhage (mean age 77, 39% women), randomized to edoxaban 60 mg (30 mg per label) or no anticoagulation; mean follow-up 28 months. Stroke or systemic embolism: 11.8% versus 12.8% (HR 0.88; 95% CI 0.61–1.26; p=0.48). Less ischemic stroke (6.2% versus 10.3%) but more hemorrhagic stroke (5.8% versus 1.9%) and more major bleeding (HR 2.23; 1.39–3.59).
Why it matters: it does not support routinely restarting oral anticoagulation after intracranial hemorrhage; the ischemic benefit is cancelled by hemorrhagic harm. It reinforces individualized decisions and the interest in left atrial appendage closure for this group, pending full publication and analyses by hemorrhage type.
https://www.radcliffecardiology.com/news/esc-congress-2026-impact-meter-day-2-what-data-show-and-what-cardiologists-think
https://www.phri.ca/research/enrich-af/

Interventional and structural cardiology

5. AIR-STEMI: complete revascularization guided by angiography-derived physiology

[Clinical trial] [Italy and Pakistan, 21 centers]
Randomized trial presented at the ESC Congress on August 30, 2026 and published in NEJM. It enrolled 1,823 patients with ST-elevation myocardial infarction and multivessel disease (median age 66, 24% women): nonculprit lesions were treated according to angiography-derived fractional flow reserve computed by a central core laboratory (PCI if ≤0.80) or according to angiography alone. At a median of 17.9 months, the composite of death, myocardial infarction, cerebrovascular event or ischemia-driven revascularization was 8.9% versus 13.7% (HR 0.62; 95% CI 0.47–0.83); myocardial infarction 3.8% versus 8.0%. There was also less contrast-associated kidney injury or major bleeding (4.6% versus 7.1%), with fewer vessels treated and less contrast.
Why it matters: it is the first large trial in which wire-free physiology improves hard outcomes in myocardial infarction while treating fewer lesions; but the analysis was done by a central core lab rather than the operator, the software is not available in every cath lab, and there was industry funding (SMT, Siemens) alongside the Italian Health Ministry.
https://www.nejm.org/doi/full/10.1056/NEJMoa2605373
https://www.tctmd.com/news/air-stemi-angiography-derived-ffr-informs-complete-pci-stemi

6. ACASA-TAVI and NOTION-4: direct oral anticoagulants after TAVI, mixed messages

[Clinical trial] [Norway and Denmark]
Two publicly funded trials presented at the ESC Congress and published in JAMA and JACC (coverage dated September 1, 2026). ACASA-TAVI (3 Norwegian centers, 360 patients aged 65 to 80 with no other indication for anticoagulation): 12 months of a direct oral anticoagulant versus aspirin reduced hypoattenuated leaflet thickening on CT (16.2% versus 28.6%; RR 0.55; 95% CI 0.37–0.82), with a noninferior safety composite (7.5% versus 10.6%) and mortality of 1.1% versus 5.6% (2 versus 10 deaths). NOTION-4: 3 months of anticoagulant followed by aspirin did not reduce leaflet thickening at 12 months (28.3% versus 32.2%; p=0.54), and the composite of death, stroke or major bleeding was worse (8.2% versus 2.3%; p=0.008).
Why it matters: the endpoint is an image, not a clinical event; the trials are small, with very few deaths and opposite safety results, and they contrast with GALILEO and ATLANTIS. They do not justify changing aspirin alone as the standard regimen after TAVI; the 5- and 10-year durability follow-up will be needed.
https://jamanetwork.com/journals/jama/fullarticle/2853401
https://www.jacc.org/doi/10.1016/j.jacc.2026.08.023
https://www.tctmd.com/news/acasa-tavi-and-notion-4-trials-give-mixed-messages-doacs-after-tavi

7. PRAGUE-26: catheter-directed thrombolysis in intermediate-high-risk pulmonary embolism

[Clinical trial] [Czech Republic, 11 centers]
Open-label randomized trial funded by the Czech Ministry of Health and Charles University, presented at the ESC Congress and published in NEJM (coverage dated September 14, 2026). It enrolled 558 patients (median age 64) with intermediate-high-risk pulmonary embolism, randomized to anticoagulation plus standard, non-ultrasound catheter-directed thrombolysis (alteplase 1 mg bolus and 1 mg/h for 9 hours per artery) or anticoagulation alone. Death, recurrence or cardiorespiratory decompensation at 7 days: 0.7% versus 6.8% (RR 0.10; 95% CI 0.02–0.44). Major bleeding 1.4% versus 2.2%; intracranial hemorrhage 0.7% versus 0%.
Why it matters: it uses ordinary catheters and low-dose alteplase, which is reproducible in a cath lab without special equipment; but it was open label, the benefit came from decompensation rather than death (4 versus 0 at 7 days), and it was run in tertiary centers with immediate rescue. It is wise to wait for PEITHO-3 before adopting it as first-line treatment.
https://www.nejm.org/doi/10.1056/NEJMoa2608012
https://www.tctmd.com/news/prague-26-catheter-directed-thrombolysis-beneficial-intermediate-high-risk-pe

8. Percutaneous left atrial appendage occlusion versus anticoagulation: possible excess of ischemic stroke

[Meta-analysis] [United States]
Bayesian meta-analysis published in JSCAI in September 2026 of six randomized trials (PROTECT AF, PREVAIL, PRAGUE-17, OPTION, CLOSURE-AF and CHAMPION-AF; 7,004 patients). Ischemic stroke: incidence rate ratio 1.34 with occlusion (95% credible interval 0.91–1.97; 94% probability of excess). Hemorrhagic stroke: 0.55 (0.23–1.18). Any stroke: 1.09 (0.76–1.56).
Why it matters: the intervals cross unity and the trials mix warfarin and direct anticoagulants and devices of different generations, so it is hypothesis-generating only; but it is a reminder that appendage occlusion trades ischemic for hemorrhagic strokes and is not equivalent to anticoagulation in patients who tolerate it.
https://www.jscai.org/article/S2772-9303(26)01372-4/fulltext
https://www.tctmd.com/news/more-strokes-especially-ischemic-laao-vs-medical-therapy-meta-analysis

9. Class I recall of Impella heart pump controllers

[Regulatory FDA] [United States]
The FDA confirmed as a Class I recall, the most serious type, the notice on the Automated Impella Controllers from Johnson & Johnson MedTech (news dated September 25, 2026). The fault lies in the purge pressure sensor, which triggers "purge disc disconnected" or "not detected" alarms; 37 serious injuries and three deaths have been reported. The manufacturer says it occurs in 0.2% of cases; the controllers can remain in use until replaced: reinsert the purge disc and, if that fails, switch to a backup controller.
Why it matters: this is at least the seventh recall related to these controllers since July 2025; centers using Impella should have a backup controller available and staff trained in the maneuver.
https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/fda-confirms-class-i-recall-impella-heart-pump

Arrhythmias and electrophysiology

10. ASPIRED: 14-day ECG patch after unexplained syncope

[Clinical trial] [United Kingdom, 45 hospitals]
Open-label randomized trial funded by the British Heart Foundation, presented at the ESC Congress on August 31, 2026 and published in NEJM. It enrolled 2,233 adults (mean age 58) with syncope unexplained after emergency department evaluation, randomized to an immediate 14-day patch monitor or usual management. Syncope episodes at one year: 1.37 versus 1.58 (incidence rate ratio 0.89; 95% CI 0.68–1.18; p=0.43). Clinically significant arrhythmia was detected in 22% versus 9%, with diagnosis at 22 versus 55 days and more pacemakers (6.8% versus 4.6%); one-year mortality 1.5% versus 2.9%.
Why it matters: the primary endpoint was neutral, so monitoring does not reduce recurrences; it finds more arrhythmias sooner, and the mortality difference is a secondary finding that needs confirmation. It supports the patch as a diagnostic tool, not as an intervention that changes prognosis.
https://www.nejm.org/doi/full/10.1056/NEJMoa2605812
https://www.escardio.org/news/press/press-releases/wearable-monitor-improves-diagnosis-of-heart-rhythm-disorders-after-fainting/

11. Resynchronization: DANISH-CRT and His-Alternative II

[Clinical trial] [Denmark]
Two Danish trials presented at the ESC Congress. DANISH-CRT (Lancet): about 1,000 patients with heart failure and wide QRS, randomized to placing the left ventricular lead at the site of latest electrical activation or at the conventional posterolateral position; death or unplanned heart failure hospitalization in 28% (139/499) versus 26% (128/501), with more lead complications in the targeted arm. His-Alternative II (JACC: Clinical Electrophysiology): conduction system pacing was noninferior to biventricular pacing for the reduction in left ventricular end-systolic volume at 6 months in patients with left bundle branch block (figures not available in the coverage consulted).
Why it matters: targeting the latest activation site adds complications without benefit, so the standard posterolateral position is enough; left bundle branch area pacing gains ground as an alternative, but on a short-term echocardiographic endpoint.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01597-7/abstract
https://www.jacc.org/doi/10.1016/j.jacep.2026.08.008
https://www.acc.org/latest-in-cardiology/articles/2026/08/29/08/48/mon-315am-comboep-esc-2026

12. FDA approves TactiFlex Duo, a dual-energy catheter (pulsed field and radiofrequency)

[Regulatory FDA] [United States]
Abbott announced on September 8, 2026 the approval of the TactiFlex Duo catheter for atrial fibrillation ablation. It rests on the FlexPulse IDE study, prospective, single-arm and uncontrolled (180 patients with drug-refractory paroxysmal atrial fibrillation), published in EP Europace on August 29: at 12 months, 74.6% were free from documented recurrence, antiarrhythmic changes or repeat ablation, with a safety event rate of 1.7%.
Why it matters: it is the first approved focal catheter that can toggle between pulsed field and radiofrequency with contact force sensing; but the evidence is single-arm, manufacturer-sponsored, with no comparison against other systems, and efficacy is similar to existing platforms.
https://abbott.mediaroom.com/2026-09-08-Abbott-receives-FDA-approval-for-its-TactiFlex-TM-Duo-Ablation-Catheter-to-treat-people-with-abnormal-heart-rhythms
https://www.hcplive.com/view/tactiflex-duo-ablation-catheter-receives-fda-approval-for-afib

Cardiac surgery and imaging

13. Heart transplantation with donation after circulatory death: outcomes stable as the practice spreads

[Publication] [United States]
Retrospective analysis of the UNOS registry published in the September 2026 issue of the Journal of Cardiac Failure: 1,489 recipients of hearts donated after circulatory death, comparing the early era (2019–2021, 303 transplants at 22 centers) with the expansion era (2022–2024, 1,186 transplants at 67 centers). One-year mortality 6.9% versus 5.8% (adjusted p=0.67), graft failure 7.6% versus 6.1% and dialysis before discharge 19% versus 18%, with no differences; none either between early- and late-adopting centers.
Why it matters: the spread of this technique, which enlarges the donor pool, has not worsened one-year results; it is a retrospective registry with short follow-up and no direct comparison with donation after brain death, and the accompanying editorial stresses the unresolved ethical questions.
https://onlinejcf.com/article/S1071-9164(26)00311-8/fulltext
https://www.tctmd.com/news/outcomes-steady-hearts-donated-after-circulatory-death-rise-us

14. REVEAL: evuzamitide PET/CT to diagnose cardiac amyloidosis

[Clinical trial, diagnostic study] [United States, 18 centers]
Open-label phase 3 diagnostic study presented at the ESC Congress and published in JAMA on August 30, 2026. In 170 adults with suspected cardiac amyloidosis (76 confirmed: 54 transthyretin and 21 light chain), PET/CT with iodine-124 evuzamitide had a sensitivity of 94% (95% CI 85–98) and a specificity of 86% (77–92) against the consensus diagnosis; it was positive in 52 of 54 transthyretin cases and 20 of 21 light-chain cases.
Why it matters: it would be the first single imaging test that detects both main amyloid types, unlike bone scintigraphy, which misses light chains; but it does not tell one type from the other, specificity could be better, the study is open label and run by the tracer's developer (Attralus), and the radiopharmaceutical is neither approved nor available in the region.
https://jamanetwork.com/journals/jama/fullarticle/2853272
https://www.hcplive.com/view/reveal-i-124-evuzamitide-pet-ct-specific-sensitive-for-cardiac-amyloidosis-diagnosis

Cross-cutting

Fifth Universal Definition of Myocardial Infarction (ESC, ACC, AHA and WHF; European Heart Journal). Numbered types are replaced by three profiles: primary infarction (formerly type 1, including spontaneous dissection, embolism and vasospasm), secondary (formerly type 2) and procedure-related (formerly types 4 and 5, defined identically for PCI and surgery, within 30 days). It adds sex-specific troponin thresholds and aligns with ICD-11. Criticism: requiring a wall motion abnormality or loss of viable myocardium for periprocedural infarction may leave events unclassified.
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehag101/8766309
https://www.tctmd.com/news/fifth-universal-definition-mi-unveiled-esc-2026

Artificial intelligence versus the heart team (Australia; JSCAI, September 2026). In 546 patients with complex coronary disease from a single Melbourne center, ChatGPT-4o and Gemini 2.0 agreed with the heart team's decision in 75% of cases when given the free clinical narrative and in only 35% with a structured form; adding guideline text did not help. Retrospective and single-center: it does not replace deliberation between surgeon and interventionalist.
https://www.jscai.org/article/S2772-9303(26)01371-2/fulltext

China (China Heart Congress, Beijing, September 18–20). The 2026 national report, presented by Gao Runlin (Fuwai Hospital), shows that age-standardized cardiovascular mortality fell 58.1% between 1990 and 2023, but ischemic heart disease has been the leading cause of cardiovascular death since 2010; hypertension accounts for 58.7% of deaths (2.64 million in 2023) with a control rate of only 12% in 2018, and about 80% of infarction deaths occur outside hospital. It is an epidemiological report, not a trial. (source in Chinese)
https://news.qq.com/rain/a/20260920A0AOVT00

United States, Hispanic population. AHA scientific statement in Circulation (coverage dated September 24): obesity in nearly 46% and hypertension in 44% of Hispanic adults, diabetes in more than 15%, and events up to 8 years earlier; it stresses that this is not a homogeneous group and that many groups of South American origin are understudied.
https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000001463

Regulatory and coverage. On September 10, Medicare (CMS) extended coverage of transcatheter aortic valve implantation to asymptomatic severe aortic stenosis and removed hospital volume requirements: https://www.tctmd.com/news/cms-finalizes-anticipated-updates-national-coverage-tavi . The FDA classified as a Class II recall the fault in Boston Scientific's LUX-Dx insertable monitors, which delay atrial fibrillation burden alerts (no injuries; fixed with a software update, no explant): https://cardiovascularbusiness.com/topics/clinical/heart-rhythm/fda-finalizes-recall-due-heart-devices-sending-delayed-alerts-software-update-way

Regions with no verifiable news this month beyond what was sent on September 28: Japan, Korea, India, Russia (the national congress in Yekaterinburg, September 24–26, published no accessible results), the Middle East, Brazil, Argentina, Mexico, Colombia, Chile, Cuba and the Dominican Republic. Chinese coverage of the traditional medicine Tongxinluo was discarded as promotional and without new data.

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 Turkish National Cardiology Congress.
• October 31 – November 3: TCT 2026, San Diego.
• November 7–9: AHA Scientific Sessions 2026, Chicago.

Monthly cardiology bulletin — October 1, 2026
14 items verified at the source: NEJM, Lancet, JAMA, JACC, Circulation and the European Heart Journal, plus regulatory notices.
Three worth your time:
• Lp(a)HORIZON: pelacarsen lowered lipoprotein(a) but did not reduce cardiovascular events in more than 8,000 patients; only a manufacturer press release so far, with no figures.
• AIR-STEMI: in 1,823 STEMI patients with multivessel disease, guiding complete revascularization with angiography-derived physiology cut events from 13.7% to 8.9% (HR 0.62); the analysis was done by a central core lab.
• ENRICH-AF: after intracranial hemorrhage, edoxaban did not reduce stroke or embolism (11.8% vs 12.8%) and doubled major bleeding (HR 2.23); open label, not yet published.
Full bulletin, with a critical reading of each study and links to the primary sources:
https://boletinesmedicos.com/en/cardiologia/2026-10-01.html
#Cardiology #HeartFailure #Cardiovascular #Lipids #AtrialFibrillation

Cardiology bulletin 10/1: Lp(a)HORIZON, pelacarsen fails to cut events in >8,000 patients; AIR-STEMI, angiography-derived physiology lowers events from 13.7% to 8.9% (HR 0.62) in multivessel STEMI. https://boletinesmedicos.com/en/cardiologia/2026-10-01.html