Michael Mindrum, MD on ASCVD and people categorized as lean mass hyper-responders.

Cardiology Testing

Predicting ASCVD With Calprotectin

Knowing which biomarkers to look for is critical to diagnosing and preventing ASCVD, and a new JAMA study suggests calprotectin could be the key to catching ASCVD early.

• Calprotectin is a protein released by white blood cells during inflammation, usually in the gastrointestinal tract.
• As a result, it’s commonly used to diagnose Crohn’s disease and ulcerative colitis, but hasn’t been explored in CVD until now.

So how does calprotectin predict ASCVD? To answer this, researchers measured calprotectin levels in plasma collected from 2.4k participants during Phase 2 of the Dallas Heart Study and found that…

• Log-transformed calprotectin levels were associated with an increased risk of ASCVD events over the study’s eight year follow-up (HR: 1.98 per level increase). 
• Higher calprotectin levels were associated with older age, male sex, Black race, hypertension, diabetes, and smoking.
• People with higher calprotectin also had higher CAC scores, A1c, LDL-C, triglycerides, and lower HDL.

Calprotectin’s ability to predict ASCVD remained statistically significant even after researchers adjusted for prior ASCVD (HR: 1.61) and traditional risk factors alongside hs-CRP, NT-proBNP, and hs-cTnT levels (HR: 1.43).

Digging into calprotectin’s role in ASCVD, researchers also conducted in-vitro experiments and observed that…

• Calprotectin damages endothelial integrity and decreases nitric oxide production in the blood vessels, indicating a direct role in ASCVD development.

The Takeaway

Catching ASCVD early is central to treating it and extending a patient’s lifespan, especially since once a blood vessel’s walls are scarred, little can be done to fix them. So, another biomarker for detecting ASCVD could play a big role if future studies align with this one.

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The Wire

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• PCI in ASCs: A new Medicare analysis of PCI patients comparing ambulatory surgical centers against outpatient hospital settings suggests the two have similar rates of adverse events. The analysis included over 400k patients and found that both groups had less than 1% all-cause mortality rate,  <1% stroke, and <1% pericardial effusion. The ASC group had a higher rate of repeat PCI, however, but the study’s numbers were too small to draw firm conclusions.

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• Inclisiran Shines for LDL-C: Novartis’ inclisiran (LEQVIO) could be better than ezetimibe as a monotherapy for reducing LDL-C in patients without ASCVD who are not on lipid lowering therapy. A recent JACC study randomized 350 patients to receive inclisiran, ezetimibe, or placebo and found that inclisiran led to a −47.9% reduction compared to placebo and −35.4% compared to ezetimibe over a six month follow-up. These findings were consistent with earlier studies evaluating inclisiran in patients on statins.

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• Amgen Off Hold: The FDA removed the clinical trial hold on Amgen’s obesity drug, AMG 513, with the company’s Phase 1 study now enrolling participants. AMG 513 was put on FDA hold back in February, though the reason why is unknown. Amgen hasn’t publicly announced how AMG 513 works, but did clarify that it didn’t think the FDA’s hold was related to the drug. The coming Phase 1 trial is expected to enroll about 80 participants with obesity, with early results slated for mid-2026.

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• FDA Turns to AI for Product Review: The FDA has found a novel solution to the shortage of reviewers for medical product applications: Have generative AI review them. The agency this week said it completed a successful pilot test of AI-assisted scientific review, and plans an “aggressive” rollout of AI across all its centers using a secure, unified platform. Generative AI will be used to free up scientific reviewers from “non-productive busywork” and spend less time on “tedious, repetitive tasks” that slow down the review process.

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The Resource Wire

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The Industry Wire

1. Cancer before age 50 is increasing.
2. FDA approves at-home HPV test.
3. American Medical Association names new CEO.
4. Post-acute providers see hiring boost amid recession worries.
5. AI assistants essential for value-based care.
6. Medicaid cuts could impact providers.
7. Kaiser Permanente mental health workers end strike.
8. GOP Medicaid policies could impact coverage for millions.
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10. Epic offers EHR training program for nurses.