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Clinical Study Summaries

STUDY SUMMARY: HeartFlow Continues to Deepen Market Access

Coronary Artery Disease (CAD)
Coronary artery disease (CAD) is the most common type of heart disease and affects 15.5 million Americans.1,2 CAD is also the leading cause of death in the United States. According to mortality data from 2013, CAD was responsible for the deaths of 1 in 7 Americans and accounted for more than 370,000 deaths.2 Moreover, CAD poses a tremendous economic burden on the US healthcare system and CAD-related expenditures are expected to soar in the coming decades. The American Heart Association projected that by 2035, direct medical costs of CAD will total $215 billion and morbidity and premature mortality will contribute an additional $151 billion in indirect costs to the total financial burden.1
Guidelines for CAD
Current practice for evaluating patients with stable chest pain often requires noninvasive or invasive testing.3,4 Coronary computed tomographic angiography (CTA) is a noninvasive anatomical test for the exclusion and detection of CAD using invasive coronary angiography (ICA) as the reference. Yet, CTA is restricted to patients at low-intermediate risk of CAD due to its relatively modest positive predictive accuracy and inability to measure functional significance.5
Invasive fractional flow reserve (FFR) is considered the gold standard to evaluate the physiological significance of coronary stenosis.5 However, executing invasive FFR is a costly and time-consuming procedure. Aside from these limitations, the FFR procedure of advancing a pressure wire across the lesion may increase the risk of rupturing a plaque or damaging the vessel wall.6-8
An alternative diagnostic and treatment pathway for CAD is the noninvasive use of fractional flow reserve by CTA (FFRCT), a screening test that simultaneously provides both anatomical and physiological coronary data to help clinicians more accurately assess significant CAD. Rajani and colleagues reported that when vessels interrogated by invasive FFR were compared against FFRCT and coronary CTA stenosis alone, FFRCT showed superior discriminatory ability with a diagnostic sensitivity of 80% and specificity of 61% in patients with a coronary stenosis severity of ≥50% (AUC 0.81 vs 0.68).  Developed by HeartFlow, this diagnostic technology was granted FDA clearance in 2014 and is now available for commercial use.5
Based on extensive clinical data, the National Institute for Health and Care Excellence (NICE) issued recommendations for HeartFlow FFRCT as a safe, noninvasive, and accurate diagnostic tool. Furthermore, relative to other tests, HeartFlow FFRCT is an economical option that potentially saves £214 per patient by avoiding unnecessary tests (Table 1).9
Additionally, the American College of Cardiology (ACC), in collaboration with partnering organizations, has released updated appropriate use criteria for performing coronary revascularization in patients with stable ischemic heart disease. These include the use of HeartFlow FFRCT to determine the appropriateness of revascularization in various clinical scenarios.10
PLATFORM Trial and Real-World Evidence
The PLATFORM trial and real-world evidence suggest that FFRCT improves accuracy of coronary CTA, and is a safe and cost-effective alternative to improve to ICA in CAD.3,11-13
PLATFORM, a multicenter, prospective, consecutive cohort study, evaluated the effectiveness of usual care testing (n = 287) compared with CTA/FFRCT (n = 297) in 584 patients with stable chest pain. The primary end point was the percentage of patients with planned ICA in whom no significant obstructive CAD was found within 90 days.3
The results shown in Table 23,12,13 demonstrate that FFRCT significantly decreases ICA in patients with suspected CAD.3
One-year follow-up data from the PLATFORM trial showed no major adverse cardiac events among the 117 patients who underwent FFRCT in place of a scheduled ICA. Data also showed a mean cost savings of 33% with the FFRCT-guided strategy compared with patients who received standard care ($8127 vs $12,145, respectively).11
Two real-world studies presented at the ACC’s 66th Annual Scientific Session & Expo showed the benefits of an FFRCT guided-strategy (Table 23,12,13).12,13 The first study demonstrated that CTA/FFRCT resulted in less ICA in symptomatic patients with intermediate CAD over a 12-month period, with no adverse events during follow-up, and at a lower cost versus a CTA-only guided strategy.13
In the second study, Kitabata and colleagues looked at the incidence and predictors of lesion specific ischemia by FFRCT in 950 patients enrolled in the ADVANCE registry—a multicenter, prospective registry designed to evaluate the real-world utility and impact of FFRCT on clinical outcomes and resource use following FFRCT-guided treatment, in clinically stable symptomatic patients diagnosed with CAD by coronary CTA.4,12 Baseline hypertension and diabetes were predictors of an abnormal FFRCT. Additionally, severity of stenosis also increased probability of an abnormal FFRCT, even when intermediate in grade.12

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