John Mandrola, MD

Understanding coronary CTA and plaque morphology has become critical for treating coronary artery disease. Tune in to this exclusive Cardiac Wire webinar on March 24th at 2:00pm ET to hear from Kashif Shaikh, MD, Brittany Weber, MD, PHD, and Udo Hoffman, MD, MPH, about the key findings from Cleerly’s CONFIRM2 registry and how it can improve clinical decision-making while supporting more equitable cardiovascular care.

Cardiology Pharmaceuticals

DAPT Drugs Matter to Diabetics with Multivessel CAD

The debate over which dual antiplatelet therapy is best for diabetic CAD patients might favor generic prasugrel over ticagrelor (AstraZeneca’s Brilinta), after the TUXEDO-2 trial demonstrated that ticagrelor isn’t equivalent to prasugrel in this complex patient group.

• Both ticagrelor and prasugrel are potent P2Y12 inhibitors recommended after PCI, yet the optimal DAPT choice for diabetic patients was undefined.
• Diabetes increases both clotting and bleeding risks, so small differences between antiplatelet drugs can affect patient outcomes.

The TUXEDO-2 trial enrolled 1.8k participants across 66 clinical sites in India and randomized patients undergoing PCI to receive either ticagrelor or prasugrel plus aspirin in an open-label study design and found that…

• The trial’s primary composite endpoint (death, nonfatal MI, stroke, or major bleeding) occurred in 16.6% with ticagrelor versus 14.2% with prasugrel, failing the 5% noninferiority threshold.
• Ticagrelor showed numerically higher (but not statistically significant) rates of the death/MI/stroke composite (10.43% vs 8.63%) and major bleeding (8.41% vs 7.14%).
• The trial enrolled a particularly high-risk group since 85% had triple-vessel disease and nearly 25% required insulin.

Even though both are potent P2Y12 inhibitors, tricagrelor’s inability to demonstrate noninferiority indicates that meaningful clinical differences may exist in high-risk patients with diabetes and extensive coronary disease.

• For example, while the differences weren’t statistically significant on their own, prasugrel showed a steady advantage across outcomes.
• This implies that the noninferiority result may represent a real effect and not just statistical noise.
• The 2.33% absolute difference in the composite outcome also represents a clinically meaningful risk when applied across the large diabetic PCI population globally.

So what does this mean for DAPT in diabetic patients post-PCI?

• While guidelines group strong P2Y12 drugs together, the TUXEDO-2 study suggests prasugrel may be the better choice for patients with diabetes and multivessel CAD.

The Takeaway

Oftentimes, when a newer drug is compared to an older one in the same drug class, studies focus on larger, more common patient groups to prove noninferiority. While that is a practical way to evaluate treatments, this study reminds us that more complex, smaller patient groups sometimes need a second look.

Discover The Monebo Advantage

Need complex ECG monitoring algorithms for use in a variety of applications? Here are just a few reasons why companies across the healthcare spectrum rely on Monebo to power their ECG monitoring and analysis.

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

Fujifilm’s Ultrasound for every Cardiovascular Ultrasound Environment

From academia to clinical diagnostics, versatility in cardiac ultrasound is essential. Discover why clinicians are choosing Fujifilm’s LISENDO 880 for exceptional image quality, comprehensive strain analysis, stress imaging, and innovative Virtual Contrast technology — all while delivering outstanding value.

The Wire

• HoFH is Different for Jack vs. Jill: Confirming yet again that men and women face different outcomes from the same disease, a multinational study revealed sex-based differences in homozygous familial hypercholesterolemia patients. The study, which initially set out to evaluate Regeneron’s evinacumab, found that baseline LDL-C levels were significantly higher in females compared to males with HoFH (8.4 vs 6.4 mmol/L). While this disparity was unexpected to many, the results emphasize the importance of greater female inclusion in cardiovascular trials and sex-specific analyses.

• ACIST Debuts in EU: Bracco’s ACIST Medical Systems subsidiary launched the ACIST Pro Diagnostic System in select European markets following its CE Mark approval under EU MDR. The next-generation automated cardiac contrast delivery system builds on ACIST CVi technology, which has shown to reduce contrast volume by an average of 45ml, while decreasing acute kidney injury by 30%, and saving five minutes per procedure compared to manual injection. The system was previously launched in Japan in 2025 with FDA 510(k) clearance pending in the United States.

• IQVIA & Duke’s Research Partnership: IQVIA and Duke Clinical Research Institute announced a collaboration to enhance clinical research in obesity and cardiometabolic trials. The partnership combines IQVIA’s operational experience and global infrastructure with DCRI’s academic background, providing end-to-end support from trial design through regulatory submission. This is on brand for IQVIA, considering that the company has supported clinical development for every FDA-approved GLP-1 therapy to date by helping conduct over 120 obesity trials and enrolling 90k+ patients.

• CCTA Plaque Measures Predict MACE: European researchers developed a set of features to characterize high-risk plaque on CCTA scans, and tested it for predicting major adverse cardiovascular events. The combination includes CAC scores ≥ 400, low-attenuation plaque, positive remodeling, and napkin-ring sign. Among 1.7k patients from the DISCHARGE trial studied, those with the features had almost 4X higher risk of MACE (HR = 3.81). If they also had obstructive CAD the risk was nearly 9X (HR = 8.78).

• Columbia & Corazon Team Up: Columbia HeartSource and Corazon announced a partnership to deliver the first national accreditation program designed specifically for open-heart surgery units. The collaboration combines Columbia University Irving Medical Center’s clinical expertise with Corazon’s strategic cardiovascular program development experience to establish new excellence standards through chart reviews, program evaluations, and quality improvement initiatives.

• ThinkSono Gets Breakthrough Nod: Expanding the horizons of intravascular ultrasound AI, the ThinkSono Guidance AI algorithm received FDA breakthrough designation for detecting deep vein thrombosis. The company notes that DVT affects up to 900k people a year in the U.S., and ThinkSono Guidance can help detect blood clots on ultrasound scans even if they are performed by non-expert users. The company is moving ThinkSono Guidance toward a regulatory submission in the U.S.

• Type A Aortic Dissection Options: A recent study of 3.5k patients aged 65 and older with acute type A aortic dissection found no survival difference at three years between simpler hemiarch replacement and extended arch reconstruction. Using the STS Adult Cardiac Surgery Database, researchers found similar rates of aortic reinterventions (HR 0.94) and comparable operative mortality (21.8% both groups), stroke, and complications between both approaches. These findings were also consistent across age categories and hospital volumes, so it seems hemiarch replacement is sufficient for most older patients.

• FIU’s Research Initiatives: Florida International University’s Center for Innovation in Cardiovascular Health announced that it successfully developed an AI algorithm that can analyze heart sounds with 95% accuracy in classifying healthy hearts and 85% accuracy differentiating disease types. The university also announced a new program for advancing robotic cardiac surgery techniques through small incisions and a program for developing a bioreactor system to preserve donated heart valves for weeks, potentially creating off-the-shelf living valve replacements that grow with pediatric patients.

• A Second Look Into Semaglutide’s SOUL: A secondary analysis of the SOUL trial found oral semaglutide (Novo’s Rybelsus) reduced heart failure outcomes by 22% in T2D patients with HF and cardiovascular or kidney disease. The benefit was significant in HFpEF patients (41% reduction) but not HFrEF. Among the study’s 9.6k participants, oral semaglutide also reduced MACE in patients without HF and potentially benefited those with heart failure. These benefits were consistent regardless of concurrent SGLT2i or MRA use.

• HOTWIRE’s Early Safety: Atraverse Medical presented clinical and preclinical data at AF Symposium 2026 validating its HOTWIRE Transseptal Access System’s safety and performance. On the preclinical side, pig studies showed zero unintended left atrial injuries versus over 50% with small-electrode RF systems, while significantly reducing RF duration and energy delivery. Meanwhile the first-in-human studies of approximately 500 and 1,000+ patients demonstrated 100% procedural success with no adverse events and low RF duration.

• STS Robotic Cardiac Surgery Pathway: The Society of Thoracic Surgeons introduced a five-phase pathway for robotic cardiac surgery to prioritize quality as the technology expands. The document outlines prerequisites, team training, initial application, efficiency, and mastery. Recommendations include three years of experience, proctoring early cases, and completing fifty procedures before attempting complex operations. Above all else, the STS emphasizes that institutional support will be needed to maintain patient safety while adopting innovation.

Heart Failure Hospitalization Doubles Risk of Cardiovascular Death

21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular death, and 25% of those who experience hospitalization are readmitted due to heart failure within one year of discharge. Watch Bayer’s Dr. Alanna Morris-Simon discuss heart failure hospitalizations and when to assess care plans.

Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF

Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.

9 Merge Cardio Features to Change Your Cardiology Workflows

Having the right tools is essential for efficient cardiology imaging workflows and delivering exceptional patient care. Read this article on how Merge Cardio can make the biggest difference to your imaging workflows, care team user experiences, and patient care delivery.

The Resource Wire

• Personalized Plaque Analysis Now With Medicare Coverage: Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.

• How Us2.ai Improves CA Screening: Cardiac amyloidosis may not be as rare as previously thought, with early and accurate detection becoming increasingly critical for treatment. Read about how the AI-SCREEN-CA study implemented Us2.ai’s automated CA reporting and AI-based pattern recognition analysis, leading to better disease screening at scale.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow: AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

• The All in One Cardiac Imaging Solution: Ready for an all-in-one solution that supports all of your MR and CT needs? See how Circle Cardiovascular Imaging’s cvi42 can streamline your core reading and reporting workflows within a single, customizable platform.

• Vista AI Grows CMR Volume: Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.

The Industry Wire

1. HHS shakes up leadership team ahead of midterms.
2. Federal judge vacates FTC premerger rule.
3. Amazon Pharmacy expands same-day delivery to 4,500 cities.
4. 50+ conservative leaders sign letter against Trump drug policy.
5. Novant Health greenlights $1B expansion plan.
6. Measles cases at university in Florida soar to 60 amid growing outbreaks.
7. NIH redefines ‘clinical trials,’ dividing researchers.
8. Why Scripps Health’s Medicare Advantage exit paid off.
9. Dana-Farber Cancer Institute receives largest ever gift.
10. Kaiser reaches settlement with DOL over behavioral care access failures.