Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization - PRECISE
Contribution To Literature:
The PRECISE trial showed that in patients with symptoms concerning for CAD, tailored use of cCTA with FFR-CT according to patient risk status resulted in less frequent invasive angiography and greater diagnostic yield for obstructive disease without an increase in death or nonfatal MI at 1 year compared with usual care.
The goal of the trial was to assess the tailored use of coronary computed tomography angiography (cCTA) with CT-derived fractional flow reserve (FFR-CT) according to patient risk status in the evaluation of suspected obstructive coronary artery disease (CAD) compared with usual care.
- International multicenter
- Open-label design
Patients without known obstructive CAD but with stable symptoms suspicious for CAD were randomized to a precision strategy (PS; n = 1,057) or usual testing (UT; n = 1,046). In the PS arm, further testing was deferred in participants with a PROMISE minimal risk score (PMRS) >0.46 (i.e., low risk), while a PMRS ≤0.46 led to cCTA with noninvasive FFR-CT for 30-90% stenoses. Testing in the UT group was at the treating clinician’s discretion.
- Total number of enrollees: 2,103
- Duration of follow-up: 12 months
- Mean patient age: 58 years
- Percentage female: 50%
- Age ≥18 years
- Stable symptoms concerning for obstructive CAD for which further nonemergent testing has been recommended
- Acute chest pain or unstable clinical status
- Noninvasive (stress testing, cCTA, or calcium scoring) or invasive CAD assessment ≤1 year prior
- Prior myocardial infarction (MI), coronary revascularization, calcium score ≥100 Agatston units, or known coronary stenosis (via cCTA or invasive coronary angiography) ≥50%
- Left ventricular ejection fraction ≤40%
- Moderate to severe valvular disease
- Congenital heart disease
- Estimated glomerular filtration rate <45 mL/min ≤90 days prior
Other salient features/characteristics:
- Percentage non-Hispanic White: 84%
- Percentage with diabetes: 18%
- Percentage with hyperlipidemia: 64%
- Percentage with PMRS >0.46 (low risk): 21% (mean age: 46 years; percentage female: 72%)
- Initial testing in UT arm: pharmacologic stress SPECT (32%), stress echocardiography (30%), exercise electrocardiogram (11%), stress cardiac MRI (10%), invasive coronary angiography (10%), cCTA (4%)
The primary outcome, composite of invasive coronary angiography without obstructive CAD (clinical efficiency endpoint) and death or nonfatal MI (safety endpoint), for PS vs. UT at 1 year, was: 4.2% vs. 11.3% (adjusted hazard ratio [aHR] 0.29, 95% confidence interval [CI] 0.20-0.41, p < 0.001).
- Obstructive CAD: angiographic stenosis ≥50% in a ≥2-mm diameter vessel, FFR ≤0.80, or instantaneous wave-free ratio (IFR) <0.90
Secondary efficacy outcomes for PS vs. UT at 1 year:
- Invasive coronary angiography without obstructive CAD: 2.6% vs. 10.2% (aHR 0.19, 95% CI 0.12-0.30)
- Revascularization after invasive coronary angiography: 9.2% vs. 5.2% (p < 0.001)
Secondary safety outcomes for PS vs. UT at 1 year:
- Hierarchical win-ratio analysis of the primary outcome: 2.81 (95% CI 1.36-6.41, p < 0.001)
- All-cause death: 0.5% vs. 0.7% (aHR 0.74, 95% CI 0.24-2.35)
- Nonfatal MI: 1.2% vs. 0.5% (aHR 2.67, 95% CI 0.94-7.52)
Prespecified secondary analysis of low-risk (PMRS >0.46) patients, PS (n = 214) vs. UT (n = 208) at 1 year:
- Primary composite outcome: 0.9% vs. 6.3% (HR 0.15, 95% CI 0.03-0.66, p = 0.01)
- Invasive coronary angiography without obstructive CAD: 0.9% vs. 5.8% (p = 0.02)
- All-cause death: 0% vs. 0.5%
- Nonfatal MI: 0% vs. 2.3%
- Mean change in Seattle Angina Questionnaire (SAQ) Summary Score: 17.9 vs. 18.7 (p = 0.63)
- Mean change in SAQ angina frequency score: 17.7 vs. 17.8 (p = 0.96)
- Any CAD testing, PS vs. UT: 83.5% vs. 93.5% (p < 0.001)
- Positive initial test, PS vs. UT: 18.3% vs. 13.3% (p < 0.001)
- Invasive coronary angiography performed, PS vs. UT: 12.8% vs. 16.9% (p = 0.007)
- Percentage of low-risk patients who underwent testing, PS vs. UT: 35.5% vs. 87.5%
The PRECISE trial demonstrated that, compared with usual care, a risk stratification approach to guide cCTA with CT-FFR versus deferred testing in low-risk patients improved invasive testing efficacy and diagnostic yield without an increased risk of death or nonfatal MI at 1 year. The PROMISE and SCOT-HEART trials of cCTA previously demonstrated comparable or improved rates of major adverse cardiovascular events, respectively, versus usual care. However, the cCTA arms in both studies demonstrated increased rates of invasive coronary angiography referral during short-term follow-up. The PRECISE investigators utilized the PMRS, a validated risk stratification tool for suspected CAD, to achieve decreased rates of invasive coronary angiography overall and invasive coronary angiography without obstructive disease, as well as more frequent revascularization after invasive coronary angiography, following cCTA compared with usual care. In a prespecified secondary analysis, low-risk patients in either arm tended to be younger and majority women. Importantly, there were no episodes of death or nonfatal MI in the deferred testing subgroup, suggesting this approach was safe. Moreover, improvements in angina severity and frequency were identical to the usual care group despite no further CAD evaluation in 64% of the deferred testing group, suggesting that this approach was not associated with unresolved symptom burden. The pragmatic trial design limits comparison of cCTA against any specific initial testing strategy, which was quite heterogeneous in the UT arm.
Overall, the current results suggest that a PMRS-stratified approach to cCTA/CT-FFR, with deferred testing after shared decision-making with low-risk patients, is a safe and effective approach for the evaluation of CAD. Extended follow-up would provide valuable insight into whether the observed trends in reduced invasive coronary angiography and comparable cardiovascular safety in the PS arm extend beyond 1 year.
Douglas PS, Nanna MG, Kelsey MD, et al. Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial. JAMA Cardiol 2023;8:904-14.
Udelson JE, Kelsey MD, Nanna MG, et al. Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease: A Prespecified Secondary Analysis of the PRECISE Randomized Clinical Trial. JAMA Cardiol 2023;8:915-24.
Clinical Topics: Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Interventions and Imaging, Computed Tomography, Nuclear Imaging
Keywords: Computed Tomography Angiography, Coronary Artery Disease, Fractional Flow Reserve, Myocardial
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