Heartflow Data Shows 4x Risk from High Plaque Volume, NAVIGATE-PCI Registry Starts

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Heartflow presented data from a 15,000-patient registry showing high plaque volume predicts a fourfold increase in major adverse cardiovascular events regardless of risk factors or stenosis severity. It enrolled the first patient in its 5,000-patient NAVIGATE-PCI Registry to test AI-guided CT planning’s effect on clinical strategy and physician confidence.

1. 15,000-Patient Registry Reveals Risk

Heartflow reported that its large-scale registry of 15,000 patients demonstrated high coronary plaque volume independently predicts a fourfold increase in major adverse cardiovascular events, irrespective of conventional risk factors or stenosis severity.

2. NAVIGATE-PCI Registry Launch

The company has enrolled the first patient in the NAVIGATE-PCI Registry, a 5,000-patient study aimed at evaluating how AI-guided CT-based pre-procedural planning impacts clinical strategy and physician confidence during catheterization procedures.

3. Strategic and Clinical Implications

These milestones advance Heartflow’s goal of transforming coronary artery disease management by validating its AI-driven diagnostic platform’s clinical benefits, potentially strengthening its competitive position in interventional cardiology and driving broader adoption of CT-based planning tools.

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