What's next in cardiology — October 24, 2026

This edition covers what is coming in cardiology between late October 2026 and the first quarter of 2027: the AHA Scientific Sessions with full data from two negative trials on Lp(a) and inflammation, two pending FDA decisions (asundexian for secondary stroke prevention and lorundrostat for uncontrolled hypertension), and the interim analysis of the PREVAIL outcomes trial of obicetrapib. Dates confirmed by official sources are included alongside expressly attributed estimates: the asundexian decision is estimated for November 2026 per the Prime Therapeutics calendar, as Bayer has not published the PDUFA date, and results of the PREVAIL interim analysis are expected in the first quarter of 2027 per NewAmsterdam Pharma.

1. AHA 2026: full data from Lp(a)HORIZON (pelacarsen) and ZEUS (ziltivekimab)

[Congress] [United States] [Confirmed date: November 7, 2026]
What it is: Late-Breaking Science session LBS.01 (Chicago, November 7, 8:30 a.m.) features Lp(a)HORIZON —pelacarsen vs placebo in 8,323 patients with established CVD and Lp(a) ≥70 mg/dL (subpopulation ≥90 mg/dL); endpoint: CV death, nonfatal MI, nonfatal stroke and urgent coronary revascularization— and ZEUS —ziltivekimab (anti–IL-6) vs placebo in more than 6,300 people with atherosclerotic CVD, CKD and inflammation. Both missed their primary endpoint per Novartis (September 4, 2026) and Novo Nordisk (July 31, 2026) announcements. STREAM (statin discontinuation in older multimorbid adults without CVD) is presented the same day, in session LBS.03.
What problem it solves: Elevated Lp(a) is a causal risk factor with no proven specific therapy; current practice is to intensify LDL-C and other risk-factor control. The full data will show whether there is a signal in the ≥90 mg/dL subpopulation, how much Lp(a) was actually lowered, and safety.
Critical take: Industry-sponsored trials with a known negative primary result; the risk is over-reading subgroups, and pelacarsen's failure does not automatically sink the siRNAs (olpasiran, lepodisiran), whose outcome trials are ongoing (OCEAN(a)-Outcomes estimated to complete March 2028, per ClinicalTrials.gov).
https://professional.heart.org/en/meetings/scientific-sessions/programming/late-breaking-science
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.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916587
https://classic.clinicaltrials.gov/ct2/show/record/NCT05581303

2. Asundexian (factor XIa inhibitor) after non-cardioembolic stroke or high-risk TIA

[Pending regulatory decision] [United States] [Estimated date: November 2026, per Prime Therapeutics ("FDA Decisions Expected: November 2026", October 21, 2026); Bayer announced FDA Priority Review on May 19, 2026 and has not published the exact PDUFA date]
What it is: The FDA accepted Bayer's NDA and granted Priority Review for asundexian 50 mg once daily added to antiplatelet therapy, based on OCEANIC-STROKE (phase 3, placebo-controlled, published in NEJM on April 15, 2026): 12,327 randomized patients; ischemic stroke 6.2% vs 8.4% (HR 0.74; 95% CI 0.65–0.84), with no significant increase in ISTH major bleeding (1.9% vs 1.7%; HR 1.10; 95% CI 0.85–1.44). Additional analyses are scheduled in AHA session LBS.02 (November 7).
What problem it solves: Recurrence risk after non-cardioembolic stroke remains high despite single or dual antiplatelet therapy, which is today's standard; asundexian would add a different mechanism, factor XIa inhibition.
Critical take: The same drug was inferior to apixaban in atrial fibrillation (OCEANIC-AF), so it does not replace anticoagulants there; bleeding was numerically higher, and price and access in our setting are unknown.
https://www.bayer.com/media/download/9b59774e-315a-49fd-81a5-f69fe9a033c0/2026-0087e.pdf
https://www.bayer.com/en-us/united-states/news-and-stories/2026/asundexian-in-patients-after-a-non-cardioembolic-ischemic-stroke
https://www.primetherapeutics.com/fda-decisions-expected-november-2026
https://www.phri.ca/oceanic-stroke/
https://www.neurologylive.com/view/newly-published-phase-3-oceanic-stroke-trial-data-show-asundexian-reduces-recurrent-ischemic-stroke-risk
https://www.escardio.org/news/press/press-releases/Asundexian-inferior-to-apixaban-for-stroke-prevention-in-atrial-fibrillation/

3. Lorundrostat (aldosterone synthase inhibitor) for uncontrolled hypertension

[Pending regulatory decision] [United States] [Confirmed date: December 22, 2026 (PDUFA date announced by Mineralys on May 6, 2026)]
What it is: The FDA accepted Mineralys' NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensives, with a PDUFA date of December 22, 2026. The phase 3 Launch-HTN trial (NCT06153693; randomized, double-blind, placebo-controlled, funded by Mineralys; 1,083 randomized adults uncontrolled despite 2–5 antihypertensives) showed a placebo-adjusted office SBP reduction of 9.1 mmHg with 50 mg daily at week 6 (95% CI −13.3 to −4.9; published in JAMA on June 30, 2025), supported by phase 2b Advance-HTN (24-hour ambulatory SBP at week 12).
What problem it solves: In resistant hypertension the usual fourth drug is spironolactone, limited by hyperkalemia and antiandrogenic effects; a selective aldosterone synthesis inhibitor aims for the same effect with better tolerability.
Critical take: Short-term surrogate endpoint (blood pressure) with no hard-outcome data; hyperkalemia outside the trial and in advanced CKD remains to be seen, and it competes with baxdrostat, from the same class.
https://www.sec.gov/Archives/edgar/data/0001933414/000193341426000082/mlys2026q18kex991.htm
https://ir.mineralystx.com/news-events/press-releases/detail/74/mineralys-therapeutics-announces-journal-of-the-american
https://clinicaltrials.gov/study/NCT06153693
https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2025/03/27/15/49/advance-htn

4. Obicetrapib: expected results of the PREVAIL trial interim analysis

[Ongoing trial] [Global] [Results expected: first quarter of 2027, per NewAmsterdam Pharma (release of August 5, 2026), which plans to conduct the analysis in the fourth quarter of 2026; a company estimate, not a confirmed date]
What it is: PREVAIL (NCT05202509) is a phase 3 randomized, double-blind, placebo-controlled trial in more than 9,500 patients with atherosclerotic CVD and LDL-C uncontrolled on maximally tolerated lipid-lowering therapy, testing whether obicetrapib reduces major adverse cardiovascular events. The company planned the interim analysis for Q4 2026 with results expected in Q1 2027. The European Commission authorized obicetrapib (Ubeslo) and its ezetimibe combination (Evlarco) for primary hypercholesterolemia or mixed dyslipidemia (announced September 21, 2026), with a post-authorization efficacy study for which it requires the final PREVAIL results.
What problem it solves: Many patients miss LDL-C targets on statin plus ezetimibe and lack access to injectable therapies; an additional oral drug with proven clinical benefit would fill that gap.
Critical take: Company-sponsored; CETP inhibitors have a history of failures (torcetrapib, dalcetrapib, evacetrapib), an interim analysis may not stop the trial, in which case the answer would come later, and the European authorization currently rests on LDL-C lowering, pending PREVAIL.
https://www.sec.gov/Archives/edgar/data/0001936258/000119312526333827/nams-ex99_1.htm
https://www.sec.gov/Archives/edgar/data/0001936258/000119312526396716/nams-20260921.htm
https://clinicaltrials.gov/study/NCT05202509

*What's next in cardiology — October 24, 2026*

1. AHA 2026: full data from Lp(a)HORIZON (pelacarsen) and ZEUS (ziltivekimab), both negative on their primary endpoint — November 7.
2. FDA: decision on asundexian (factor XIa inhibitor) after non-cardioembolic stroke — estimated November 2026.
3. FDA: decision on lorundrostat for uncontrolled hypertension — December 22, 2026.
4. PREVAIL (obicetrapib): expected interim outcomes analysis result — estimated Q1 2027, per NewAmsterdam.

Full text and audio: https://boletinesmedicos.com/en/cardiology/2026-10-24-viene.html
MedBulletins · boletinesmedicos.com

What's next in cardiology (November 2026 to March 2027), with official sources and attributed estimates:

• November 7, AHA 2026: full data from Lp(a)HORIZON (pelacarsen) and ZEUS (ziltivekimab). Both missed their primary endpoint; the debate will be about subgroups and safety.
• November 2026 (estimated): FDA decision on asundexian, a factor XIa inhibitor, after non-cardioembolic stroke (OCEANIC-STROKE: −26% ischemic stroke).
• December 22, 2026: FDA decision on lorundrostat, an aldosterone synthase inhibitor, for uncontrolled hypertension.
• Q1 2027 (estimated, per NewAmsterdam): expected results of the PREVAIL interim analysis, the obicetrapib outcomes trial.

The clinical problem behind each one and our critical take:
https://boletinesmedicos.com/en/cardiology/2026-10-24-viene.html

#Cardiology #Hypertension #LipoproteinA #Stroke #EvidenceBasedMedicine

What's next in cardiology: AHA 2026 with Lp(a)HORIZON and ZEUS (Nov 7), FDA on asundexian (Nov, est.) and lorundrostat (Dec 22), and expected PREVAIL obicetrapib interim results (Q1 2027, est., per NewAmsterdam). https://boletinesmedicos.com/en/cardiology/2026-10-24-viene.html