Cardiovascular Today—Februrary 12, 2026

This weekly Cardiovascular update covers clinical progress, guideline changes, regulatory milestones, and research initiatives. Highlights include late-stage trial data, updated care pathways, device developments, and real-world evidence signals. Language is neutral and evidence-led.

In Today’s Newsletter

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🧠 Statins label risks re-examined in Lancet meta-analysis [1] [10 Feb 2026]

https://cardiovascularnews.com/statins-likely-not-the-cause-of-most-side-effects-listed-on-packaging-leaflets/
Context: 23 placebo-controlled and 4 intensity-comparison RCTs, 154,664 participants total; Oxford Population Health analysis in The Lancet.
Key point: Most listed adverse effects, including cognitive issues and sleep disturbance, were not increased vs placebo; small rise in liver test abnormalities without clinical liver disease.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 ALPHA-PE Research Fund launches for investigator-led PE studies [2] [06 Feb 2026]

https://cardiovascularnews.com/investigator-led-initiative-supporting-pe-research-launched/
Context: AngioDynamics and The PERT Consortium to award US$50k–US$750k over 1–3 years for independent PE research.
Key point: Program targets real-world evidence gaps in PE management, with LOI then full proposal process.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.

🫀 TricValve bicaval system gains EU MDR CE mark [3] [EU • 09 Feb 2026]

https://cardiovascularnews.com/tricvalve-bicaval-valve-system-gains-eu-mdr-certification/
Context: Class III implant for severe TR with caval reflux; prior MDD CE in 2021; US use under IDE, TRICAV II pivotal RCT authorized.
Key point: MDR certification secures EU availability under stricter surveillance and supports international expansion.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.

🔧 STS data: mortality improving for SAVR after prior TAVI [4] [US • 09 Feb 2026]

https://cardiovascularnews.com/sts-data-suggest-surgeons-have-begun-to-shift-the-tide-in-tavi-explant-mortality/
Context: STS Adult Cardiac Surgery Database, 5,708 SAVR-after-TAVI cases across ~700 US centers, 2014–2025; late-breaker at STS 2026.
Key point: Operative mortality and complications have declined over time, with higher risk when concomitant procedures are needed.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🫳 Off-pump CABG by experienced surgeons shows lower perioperative events, similar long-term survival [5] [US • 09 Feb 2026]

https://cardiovascularnews.com/off-pump-cabg-in-experienced-hands-reduces-perioperative-complications-with-similar-long-term-survival/
Context: STS Adult Cardiac Surgery Database analysis, 2008–2023; >184k OPCAB vs 1.34m ONCAB, 184k propensity-matched pairs; presented at STS 2026.
Key point: OPCAB had lower perioperative morbidity and mortality; long-term survival largely similar, with a small advantage in single-vessel disease; completeness of revascularization lower with OPCAB.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 Asundexian cuts recurrent stroke in OCEANIC-STROKE [6] [US • 06 Feb 2026]

https://pharmaphorum.com/news/bayer-reveals-data-behind-asundexians-stroke-win
Context: Phase 3 in >12,300 non-cardioembolic ischaemic stroke/TIA patients on antiplatelets; full data at ISC, New Orleans.
Key point: 50 mg daily reduced recurrent stroke by ~26% vs placebo without increasing major bleeding; favorable composite outcomes reported.
Implication: May influence prescriber choice and payer reviews pending full data.

🏥 AHA/ASA updates early AIS management guideline [7] [US • 06 Feb 2026]

https://www.pulmonologyadvisor.com/news/guideline-updated-for-early-management-of-acute-ischemic-stroke/
Context: Replaces 2018 guideline; Stroke publication on 26 Jan 2026.
Key point: Endorses alteplase or tenecteplase within 4.5 hours for disabling deficits without advanced imaging; broadens EVT, including basilar occlusion ≤24 hours; includes MSU and pediatric recommendations.
Implication: May expand screening, initiation, and follow-up at scale.

🛡️ Abbott’s Amulet 360 hits early endpoints in VERITAS [8] [US • 06 Feb 2026]

https://abbott.mediaroom.com/press-releases?item=124733
Context: 400 patients, 34 sites across US, Canada, Europe; AF Symposium late-breaker, concurrent JACC: Clinical Electrophysiology publication.
Key point: 99.8% implant success; 93.9% complete LAA closure at 45 days; low early complications with one device-related thrombus.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Statin safety clarification could reduce discontinuation and improve cardiovascular risk control [1].
Factor XIa inhibition may reshape secondary stroke prevention if benefits persist without excess bleeding [6].
EVT and thrombolysis access may expand under the updated AIS guideline, including pediatric pathways [7].
EU MDR certification maintains patient access to structural options in severe TR and pressures competitors [3].
Growing experience appears to be improving outcomes for complex valve reinterventions and CABG strategy choices [4][5].

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FAQ

Does the Lancet statin analysis refute cognitive side effects?

It found similar rates of cognitive or memory impairment on statins and placebo, suggesting no meaningful excess risk from statins for these symptoms [1].

What kinds of PE studies does ALPHA-PE aim to fund?

Independent, physician-led research on outcomes, workflows, and novel approaches to improve real-world PE care, with awards of US$50k–US$750k over 1–3 years [2].

What does EU MDR CE mean for TricValve availability?

It confirms compliance with stricter post-market requirements, securing EU availability and supporting broader expansion while US access remains under IDE with a pivotal RCT ongoing [3].

Are surgeons getting safer at TAVI explant to SAVR?

STS data suggest declining operative mortality and complications over time, though risk remains higher with concomitant procedures [4].

Is off-pump CABG better than on-pump?

Per STS database analysis in experienced hands, OPCAB lowered perioperative events with largely similar long-term survival, but with more incomplete revascularization [5].

Will asundexian replace antiplatelets?

In OCEANIC-STROKE it was added to antiplatelets and reduced recurrent stroke without more major bleeding; potential use depends on regulatory approvals and labeling [6].

What changed in early AIS care?

The guideline endorses alteplase or tenecteplase within 4.5 hours for disabling deficits without advanced imaging and broadens EVT indications, including basilar occlusion within 24 hours, with new pediatric recommendations [7].

Entities / Keywords

Statins; Oxford Population Health; The Lancet; AngioDynamics; The PERT Consortium; ALPHA-PE; P&F Products and Features; TricValve; EU MDR; Severe tricuspid regurgitation; STS Adult Cardiac Surgery Database; TAVI explant; SAVR; Off-pump CABG; OPCAB; ONCAB; Bayer; Asundexian; OCEANIC-STROKE; Factor XIa; AHA/ASA; Acute ischaemic stroke guideline; EVT; Tenecteplase; Abbott; Amulet 360; VERITAS; LAA occlusion.