Key Points:
- There is substantial heterogeneity in the use of different non-invasive and invasive modalities for CAD risk stratification; however, there limited is RCT evidence dictating the optimal strategy.
- In the PRECISE study, patients with typical or atypical symptoms suggestive of potential CAD were randomized to either a risk-score based, “precision” strategy or usual care. The primary outcome of interest was a 1-year composite of death, nonfatal MI, or a coronary catheterization yielding no obstructive CAD.
- The precision strategy resulted in a significant 70% reduction in the primary outcome at 1 year compared to usual care.
While recent guidelines have provided suggestions for the most appropriate testing to assess for CAD in low, moderate, and high-risk patients, there is limited data demonstrating the efficacy of these approaches on clinical outcomes. A guideline-based, patient-specific recommendation for CAD screening could be deemed a “Precision Strategy” for CAD evaluation. In a breaking presentation at the 2022 AHA Scientific Sessions today, Dr. Pamela Douglas (Duke Clinical Research Institute) and her team presented their study: “A precision evaluation strategy for coronary artery disease risk stratification improves outcomes,” or the PRECISE trial.
The PRECISE study (NCT03702244) was a multi-center randomized clinical trial conducted across 65 sites in North America and Europe which evaluated the effects of a “precision strategy” comprising CAD testing assigned by the PROMISE Minimal Risk Score (PMRS) against usual testing determined by the clinician. If the PMRS score indicated low risk, testing was deferred; patients at elevated risk received coronary CTA (cCTA) +/- FFR. The inclusion criteria comprised any adults with typical or atypical symptoms concerning for potential CAD with no CV testing in the past year; relevant exclusions included unstable clinical status or an acute chest pain presentation, lifetime known history of obstructive CAD, and contraindications for cCTA. A total of 2,103 patients were randomized. The mean age was 58, and 50% of patients were female; 18% had diabetes, and 94% had more than one CV risk factor. The average ASCVD 10-year risk was 8%, and a quarter of patients had typical angina. In the precision strategy group, cCTA was performed in 48% of patients, and an additional 31% had cCTA + FFR performed; these proportions were 1% and 0% in the usual testing group, respectively, where SPECT (32%), Stress Echo (30%), and Treadmill ECG (11%) were the most prevalent.
The primary outcome was a composite of death, nonfatal MI, or a coronary catheterization yielding NO obstructive CAD, which was designated as a measure of “net clinical effectiveness;” over a median follow-up of 12 months, the precision strategy resulted in a substantial reduction in the primary composite outcome (aHR 0.29, 95% CI 0.20-0.41; win ratio 2.81 [1.36-6.41]; p<0.001). A subgroup analysis of the primary outcome demonstrated no interaction with regards to age, sex, race, geographic region, ASCVD score, or primary symptom presentation. However, patients with an intended invasive first test prior to randomization received more benefit from the precision strategy (p-interaction < 0.001). Patients in the precision strategy arm had fewer antiplatelet and lipid-lowering prescriptions (p<0.001 for both).
When discussing the clinical implications of the study at AHA, Dr. Douglas stated: “The precision strategy care pathway includes several actions reflective of real-world decision-making: risk stratification, deferred testing, and use of cCTA with selective FFR….the separate effects of each action can not be determined….however, PRECISE demonstrates the net clinical effectiveness of the precision strategy with a 70% reduction of the composite of death, non-fatal MI, or catheterization without obstructive CAD relative to usual testing at one year.”