“Progress is impossible without change, and those who cannot change their minds cannot change anything.”
– George Bernard Shaw
This motivation to advance the world of healthcare through change is rooted deeply in many talented providers with whom I have worked. A relentless focus on finding a better path for each individual patient for whom they care drives decisions, and in time, it leads to careful assessment of clinical adjustments enabling broader change. This drive to identify better options leading to improved outcomes for patients was front and center in the clinical science presented at TCT Connect 2020 last week.
A striking example of this was the FORECAST trial presented by Professor Nick Curzen of University Hospital Southampton. In this trial, we have our first chance to assess the clinical impact of the HeartFlow Analysis through the lens of a multi-center, randomized controlled trial in a coronary CTA-first world. This is also the first large prospective study to assess the impact of the HeartFlow Analysis in a setting of primarily CTA-first testing across the full range of patient risk, from low to very high pre-test likelihood of coronary artery disease (CAD).
Numerous prior controlled but nonrandomized studies have demonstrated that a coronary CTA+HeartFlow pathway provides significant benefits to patients and providers as compared to either CTA-first testing, or (more common) functional ischemia-testing, or taking patients directly to the cath lab. The FORECAST trial confirms and extends those previous learnings: investigators at 11 NHS hospitals in the UK randomized 1,400 patients presenting with recent onset chest pain to either a CTA+HeartFlow pathway or a standard diagnostic pathway. Among the pronounced clinical benefits of a CTA+HeartFlow pathway highlighted by FORECAST are:
Efficiency of cardiac care, both in invasive and non-invasive settings, when used in the setting of predominantly CTA-first testing:
- 22% reduction in diagnostic invasive coronary angiograms (ICAs)
- 52% reduction in negative (i.e., in retrospect unnecessary) diagnostic ICAs
- No change in revascularization rates
- 36% improvement in cath lab efficiency (36% improvement in the ratio of revasc : ICA) with 75% of ICAs leading to revascularization in the CTA+HeartFlow arm, the highest such ratio ever reported for non-ACS patients.
- 40% reduction in layered non-invasive testing
- No change in MACCE rates or clinical outcomes despite the much more selective use of invasive and layered noninvasive testing in the CTA+HeartFlow arm
- These clinical benefits are delivered to patients and providers with no increase in overall costs within the UK NHS healthcare system, even with the inclusion of high-risk patients, all of whom almost certainly required invasive management regardless of the pathway to which they were assigned.
These learnings are possible because of the work done years ago within the NHS system to transition to a CTA-driven pathway for patients presenting with stable chest pain. In 2016, clinical guidance from the United Kingdom’s National Institute for Health and Care Excellence (NICE) indicated that hospitals should forego functional testing and instead begin utilizing coronary CTA for stable chest pain patients across the spectrum of pre-test likelihood of CAD. And in 2017, NICE recommended use of the HeartFlow FFRCT Analysis to aid in determining which patients whose pre-test likelihood was 10% - 90% and whose CTA showed CAD of uncertain functional significance should be considered for invasive assessment.
Of note, the FORECAST trial endpoint contrasts with the NICE models in two critical ways:
- FORECAST was powered to demonstrate a 20% cost savings, a much higher anticipated savings than that indicated by any published NICE model.
- Enrollment was open to all patients presenting to the RACPC in whom a test was required. This included both high-risk patients undoubtedly bound ultimately for ICA, a population in whom NICE never anticipated utilising the HeartFlow Analysis, and low risk patients who underwent only exercise treadmill testing only, not consistent with NICE’s CG95 guidance. Not surprisingly the 7% of patients in whom the investigator initially wanted to perform ICA directly, presumably because of high risk clinical features, showed higher costs of care when assigned to CTCA and FFRCT and should probably be managed with ICA directly.
Where the FORECAST trial aligns almost perfectly with the published NICE models is in the stratum of patients in whom the investigator initially wanted to perform functional non-invasive testing. In this group, the median costs for the arm randomized to CTA ± HeartFlow were £200-250 lower than in the group undergoing functional ischemia testing although with under 200 patients in each arm, this difference did not reach statistical significance.
Applying the findings of FORECAST to the work done across the NHS system today tells us that widespread adoption of a CTA-first pathway, in which about one third of patients require HeartFlow FFRCT, would enable the avoidance of more than 24,000 layered non-invasive cardiac tests and 30,000 diagnostic ICAs in the NHS annually.1
Beyond FORECAST, it has been encouraging to see the progression of NHS hospital teams who have fully adopted a CTA-first pathway for these patients. Clinical impacts such as decreased time-to-diagnosis, reduced waiting times, and increased cath lab efficiency, mirroring those found in FORECAST, are being widely reported. And on an operational level, we know that clinical teams at the centers across the NHS have improved their acquisition of coronary CTA images through basic protocol adjustments that are enabling more informed clinical decision making.
FORECAST confirms and extends the clinical advantages of this pathway with a rigor and breadth not seen before. We send our congratulations to the clinical teams who contributed to FORECAST and who are changing the way we identify and treat cardiovascular care.