Cleerly’s Downstream Effect

A new AJR study showed that Cleerly’s coronary CTA AI solution detects obstructive coronary artery disease (CAD) more accurately than myocardial perfusion imaging (MPI), and could substantially reduce unnecessary invasive angiographies. 

The researchers used Cleerly to analyze Coronary CTAs from 301 patients with stable myocardial ischemia symptoms who also received stress MPI exams. They then compared these Cleerly CCTA and MPI results with the patients’ invasive angiography exams, and quantitative coronary angiography (QCA) and fractional flow reserve (FFR) measurements. 

The Cleerly-based coronary CTA results significantly outperformed MPI for predicting stenosis and caught cases that MPI-based ischemia results didn’t flag:

  • Cleerly AI detected more patients with obstructive stenosis (≥50%; 0.88 vs. 0.66 AUCs)
  • Cleerly AI identified more patients with severe stenosis (≥70%; 0.92 vs. 0.81 AUCs)
  • Cleerly AI detected far more patients with signs of ischemia in FFR (<0.80; 0.90 vs. 0.71 AUCs) 
  • Out of 102 patients with negative MPI ischemia results, Cleerly identified 55 patients with obstructive stenosis and 20 with severe stenosis (54% & 20%)
  • Out of 199 patients with positive MPI ischemia results, Cleerly identified 46 patients with non-obstructive stenosis (23%)

MPI and Cleerly-based CCTA analysis also worked well together. The combination of ≥50% stenosis via Cleerly and ischemia in MPI achieved 95% sensitivity and 63% specificity for detecting serious stenosis (vs. 74% & 43% using QCA measurements).

Based on those results, pathways that use a Cleerly AI-based CCTA benchmark of ≥70% stenosis to approve patients for invasive angiography would reduce invasive angiography utilization by 39%. Meanwhile, workflows requiring a positive MPI ischemia result and CCTA Cleerly AI benchmark of ≥70% would reduce invasive angiography utilization by 49%.

The Takeaway
We’re seeing strong research and policy momentum towards using coronary CTA as the primary CAD diagnosis method and reducing reliance on invasive angiography. This and other recent studies suggest that CCTA AI solutions like Cleerly could play a major role in that CCTA-first shift.

A CT-First Approach to CAD

A major new study from the DISCHARGE Trial Group showed that coronary CT is as effective as invasive coronary angiography (ICA) for the management of patients with obstructive coronary artery disease (CAD), potentially challenging current guidelines. 

Background – Invasive coronary angiography (ICA) is the reference standard for diagnosing and managing CAD and it’s performed over 3.5 million times each year in the European Union alone (many more millions globally). However, over 60% of these exams prove negative and theoretically could have been diagnosed via non-invasive CT exams.

The Study – The randomized, multi-center trial (26 sites, 16 EU countries) used CT or ICA as the initial diagnostic and treatment guidance exam for 3,523 patients with stable chest pain and intermediate probability of obstructive CAD (1,808 patients w/ CT). By the end of the study’s 3.5-year follow-up period, patients in the CT group had: 

  • A lower rate of major adverse cardiovascular events (2.1% vs. 3% w/ ICA)
  • A far lower major procedure-related complication rate (0.5% vs. 1.9% w/ ICA)
  • A slightly higher rate of reported angina (8.8% vs. 7.5% w/ ICA)

The Takeaway

These results suggest that following a CT-first strategy for evaluating patients with a medium risk of CAD produces similar longer-term outcomes as the current ICA-first strategy (maybe even better outcomes), while significantly reducing major complications and unnecessary cath lab procedures.

That’s pretty compelling and could actually influence procedural changes, given the size / credibility of the DISCHARGE Trial Group and the fact that CT was already proposed in the Chest Pain Guidelines as a gatekeeper for invasive coronary angiography.

One-Stop Cardiac CT

A new Radiology Journal study found that combining Triple-rule-out CT (TRO CT) with Late Contrast Enhancement CT (LCE CT) significantly improves acute chest pain diagnosis.

Background – It’s traditionally been challenging to diagnose patients with acute chest pain and mild troponin rise, as TRO CT is effective for several key diagnoses (coronary artery disease, acute aortic syndrome, pulmonary embolism) but can’t identify nonvascular causes of myocardial injury.

The Study – The researchers examined 84 troponin-positive patients with acute chest pain using TRO CT, and then performed LCE CT exams on the 42 patients who had negative/inconclusive results. 

The Results – The added LCE CT exams revealed positive/conclusive findings in 34 of the 42 previously-negative/inconclusive patients (including 22 w/ myocarditis), improving overall diagnostic rates from 50% to 90% (from 42/84 to 76/84).

The Takeaway – This new TRO CT + LCE CT protocol could make cardiac CT a “one-stop shop” for diagnosing acute chest pain, eliminating the need for follow-up MRI exams and allowing faster diagnoses. That’s especially notable considering that CT is already recommended for patients with low-risk acute chest pain (to exclude CAD) and was recently proposed as a gatekeeper for invasive coronary angiography.

Chest Pain Imaging Guidance

If it seemed like coronary imaging folks were more excited than usual last week, it’s because the AHA/ACC’s long-awaited chest pain guidelines just set the stage for a lot more imaging.

The Guidelines – The American Heart Association (AHA) and the American College of Cardiology (ACC) released their first clinical guidelines for the assessment and diagnosis of chest pain, outlining a range of new standards, processes, and pathways, while giving coronary imaging a central diagnostic role.

Front-Line Coronary CTA – The new guidelines made coronary CTA a front-line coronary artery disease test, assigning CCTA their highest recommendation level and proposing it for a large group of patients (mid-high risk of CAD, stable chest pain, <65yrs).

FFRct Next in Line – HeartFlow’s FFRct analysis will often serve as the next diagnostic step when CCTA exams reveal obstructive CAD (40-90% stenosis) or are inconclusive, with FFRct results either clarifying diagnosis or supporting treatment decisions. 

Stress Imaging Pathways – The AHA/ACC guidelines also gave stress imaging (e.g. TTE, echo, CMRI, PET, etc.) their highest recommendation level, positioning stress imaging for more serious cases (likely or confirmed obstructive CAD, ≥65yrs) as well as for diagnosing myocardial ischemia and estimating risks of major cardiac events among patients with less severe cases (intermediate risk, no known CAD, acute chest pain).

Takeaway – These new guidelines are a big deal for coronary imaging, given the millions of people who show up at US emergency departments with chest pain each year. It’s also going to require some big changes across EDs, imaging centers, and radiology departments/practices, who will have to retool their imaging protocols/fleets and be able to expertly interpret a wave of coronary imaging exams (and handle a wave of incidentals).

Silent Atherosclerosis

A new study in Circulation used coronary CTA scans and CAC scoring to reveal a surprisingly high prevalence of “silent” coronary artery atherosclerosis in the general population, suggesting that this could “lay the foundation” for future CT-based cardiac screening programs.

The Study – The researchers analyzed CCTA and CAC exams from 25k randomly recruited Swedish participants (50-64yrs, none w/ known coronary heart disease) finding that:

  • 42% had CCTA-detected atherosclerosis
  • 8.3% had noncalcified plaques
  • 5.2% had significant stenosis
  • 1.9% had serious coronary artery diseases
  • All participants with >400 CAC scores had atherosclerosis (yes, 100%), and 45.7% had significant stenosis
  • Some participants with 0 CAC scores had atherosclerosis (5.5%) and significant stenosis (0.4%)
  • So, CAC-based screening might still miss some at-risk patients

The Takeaway – 2021 brought a notable surge in academic and business efforts focused on CT-based cardiac screening, and this study’s revelation about “silent” atherosclerosis in the general population suggests that cardiac screening’s momentum will continue.

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-- The Imaging Wire team

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