Cardiovascular Today—November, 13 2025

This week’s cardiovascular news highlights new clinical trial results, digital health pilots, and real-world evidence in cardiovascular and stroke care. It also covers evolving guidelines, access and equity initiatives, and advances in long-term rhythm monitoring.

In Today’s Newsletter

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📱 Otsuka, NCVC launch app-enabled salt-reduction study in Japan [1] [JP • 05 Nov 2025]

https://www.otsuka.co.jp/en/company/newsreleases/2025/20251105_1.html
Context: Joint research with Japan’s National Cerebral and Cardiovascular Center using Vivoo urine strip–AI app in cardiac rehab outpatients.
Key point: Exploratory trial will assess whether at-home salt tracking and dietitian-guided advice can change behavior in heart disease or hypertension.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.

🧠 LT3001 (odatroltide) Phase 2b hits safety, trends to benefit in AIS, planning Phase 3 [2] [05 Nov 2025]

https://www.neurologylive.com/view/acute-stroke-therapy-lt3001-eyes-phase-3-studies-following-positive-phase-2b-data
Context: Data presented at World Stroke Congress; China Phase 2b and a smaller US/EU/TW Phase 2 reported no treatment-related sICH.
Key point: Directional gains in 90-day mRS, including select subgroups; company signals movement to Phase 3 (endpoints not fully detailed).
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Finerenone (Kerendia) gains heart failure indication in India [3] [IN • 08 Nov 2025]

https://www.fortuneindia.com/business-news/bayers-chronic-kidney-disease-therapy-kerendia-gets-additional-approval-as-heart-failure-drug-too-in-india/127990
Context: India regulator cleared Kerendia for HFpEF/HFmrEF; prior Indian approval in CKD with T2D.
Key point: Approval cites FINEARTS-HF Phase 3 showing 16% reduction in composite CV death and total HF events.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.

🧬 Polygenic risk scores boost AHA PREVENT risk tool performance [4] [US • 10 Nov 2025]

https://www.genomics.com/newsroom/aha-2025-new-study-from-genomics-shows-polygenic-risk-scores-improve-the-accuracy-of-cardiovascular-disease-risk-prediction
Context: Kaiser Permanente data evaluated PRS integrated with PREVENT 10-year ASCVD risk at AHA 2025.
Key point: PRS improved prediction (e.g., NRI 6%), reclassified ~8% of adults 40–69 to higher risk, enabling earlier statin targeting.
Implication: Observational/RWE: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧪 STRIVE: Intracoronary alteplase fails to improve STEMI outcomes with high thrombus [5] [US • 11 Nov 2025]

https://cardiovascularnews.com/alteplase-fails-to-impact-outcomes-in-stemi-patients-with-high-thrombus-burden/
Context: Multicentre, randomized, double-blind trial presented at TCT 2025; JACC publication.
Key point: Low-dose intracoronary tPA during primary PCI did not reduce composite MACE or microvascular obstruction metrics vs placebo.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🫀 Tendyne TMVR shows promise in severe MAC cohort (SUMMIT-MAC) [6] [US • 11 Nov 2025]

https://cardiovascularnews.com/tendyne-system-shows-promise-in-patients-with-mitral-annular-calcification/
Context: Prospective multicentre study, elderly high-risk patients; TCT 2025 late-breaker, JACC publication.
Key point: High technical success, 1-year MR ≤ mild in 97%, NYHA and KCCQ improved; transapical access bleeding noted.
Implication: May influence prescriber choice and payer reviews pending full data.

🫱‍🫲 Sapien M3 transseptal TMVR effective in ineligible surgery/TEER patients (ENCIRCLE) [7] [US • 11 Nov 2025]

https://cardiovascularnews.com/transseptal-tmvr-system-shows-promise-in-patients-unsuited-for-surgery-or-teer/
Context: Pivotal study across US, Canada, EU, Israel, Australia; presented at TCT 2025, published in The Lancet.
Key point: 1-year death or HF hospitalization 25.2% vs 45% goal; durable MR reduction and QoL gains with transfemoral, fully percutaneous system.
Implication: May influence prescriber choice and payer reviews pending full data.

👩‍⚕️ Report calls for equity in women’s heart valve care [8] [11 Nov 2025]

https://cardiovascularnews.com/report-seeks-to-level-the-playing-field-for-women-in-heart-valve-care/
Context: Global Heart Hub report co-chaired by patient and clinician leaders, highlights gaps in diagnosis and trial inclusion.
Key point: Recommends sex-aware guidelines, better recruitment, education, and access to diagnostics for women with valve disease.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.

💉 UIS review: Sitagliptin’s vascular effects may aid heart protection [9] [US • 11 Nov 2025]

https://www.nprillinois.org/health-harvest/2025-11-11/uis-study-finds-diabetes-drugs-vascular-effects-may-help-protect-the-heart
Context: Review in Cardiovascular Science of clinical and lab data on sitagliptin’s endothelial and anti-inflammatory effects.
Key point: Does not prevent major events but may limit small-vessel damage; low-cost generic option for some patients.
Implication: Observational/RWE: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

📈 iRhythm RWE: 1.1M-patient Heart Rhythm paper, AHA data support 14-day LTCM [10] [US • 11 Nov 2025]

https://investors.irhythmtech.com/news/news-details/2025/iRhythm-Technologies-Announces-Publication-of-Large-Scale-Studyin-Heart-Rhythm-and-New-Data-Presented-at-AHA-Scientific-Sessions-2025/default.aspx
Context: Heart Rhythm publication plus multiple AHA analyses on Zio 14-day monitoring, home self-application, and CKM/CKD risk cohorts.
Key point: 24–48-hour monitoring missed many actionable arrhythmias; mean time to first arrhythmia >48 hours across types; home self-apply achieved high wear and data quality.
Implication: May expand screening, initiation, and follow-up at scale.

Why it matters

Primary prevention is shifting with genetics, as PRS augments PREVENT risk stratification for earlier statin use.
Interventional frontiers continue in MR, with both transapical and transseptal TMVR platforms showing clinically meaningful gains.
Not all cath-lab adjuncts help, as intracoronary alteplase adds no benefit in high-thrombus STEMI.
Remote tech and long-term ECG monitoring are scaling access and detection, while sex-equity efforts target persistent valve-care gaps.

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FAQ

What is Otsuka testing with NCVC in Japan?

A joint exploratory study will evaluate whether the Vivoo urine-strip app and dietitian-guided feedback can drive salt-reduction behavior in cardiac outpatients in rehab programs [1].

What did LT3001 show in stroke patients?

Across Phase 2b and a smaller Phase 2, LT3001 met primary safety with no treatment-related sICH and showed directional mRS improvements, supporting planned Phase 3 trials (endpoints not fully specified) [2].

What changed for Kerendia in India?

India approved finerenone for heart failure, citing FINEARTS-HF Phase 3 showing a 16% reduction in a composite of CV death and total HF events, in addition to its CKD with T2D use [3].

How much did PRS help the PREVENT tool?

In Kaiser data, adding PRS improved classification metrics such as NRI ~6% and reclassified about 8% of adults 40–69 to higher risk, potentially enabling earlier statin therapy [4].

Did intracoronary alteplase help STEMI PCI patients?

No. In STRIVE, low-dose intracoronary alteplase did not reduce the composite primary outcome vs placebo in high-thrombus STEMI during primary PCI [5].

How do Tendyne and Sapien M3 differ?

Tendyne is a retrievable transapical TMVR that showed strong MR reduction and QoL gains in severe MAC; Sapien M3 is fully percutaneous transseptal with favorable 1-year outcomes vs a performance goal in patients ineligible for surgery or TEER [6][7].

Why is iRhythm emphasizing 14-day monitoring?

RWE in 1.1M patients showed many actionable arrhythmias arise after 48 hours, and home self-application achieved high wear and data quality, supporting longer LTCM over 24–48-hour Holter in many cases [10].

Entities / Keywords

Otsuka, National Cerebral and Cardiovascular Center, Vivoo; Lumosa Therapeutics, LT3001, odatroltide, AIS; Bayer, finerenone, Kerendia, FINEARTS-HF, HFpEF, HFmrEF; Genomics, polygenic risk score, PREVENT, ASCVD; STRIVE, alteplase, tPA, STEMI, PCI; Abbott Tendyne, MAC, SUMMIT-MAC; Edwards Sapien M3, ENCIRCLE, TMVR, TEER; Global Heart Hub, women’s valve disease; sitagliptin, DPP-4 inhibitor; iRhythm, Zio, long-term continuous monitoring, Heart Rhythm, AHA 2025, CKM, CKD.