Randomized Study Comparing Angiography Guidance With Physiology Guidance After PCI: The EASY-PREDICT Study.

BACKGROUND

Physiology assessment of coronary lesion prepercutaneous coronary intervention (PCI) using hyperemic and nonhyperemic pressure ratios is useful to determine if a lesion requires treatment. Whether the physiology after PCI is superior to angiography guidance only is unknown. The study sought to investigate whether post-PCI physiology improves clinical outcomes compared with standard angiographic guidance.

METHODS

All-comers patients referred for diagnostic angiography and possible PCI were recruited in a high-volume tertiary care hospital. After uncomplicated PCI, patients were randomized to angiography guidance or target vessel physiology, including nonhyperemic pressure ratio (resting distal coronary pressure to aortic pressure ratio and diastolic pressure ratio) and fractional flow reserve. The primary outcome was the rate of target vessel failure, including cardiac death, myocardial infarction, and target vessel revascularization at 18 months post-PCI. Angina score, medications, and quality of life were also assessed.

RESULTS

Two hundred twenty-one patients were randomized in the angiography group (110 patients, 166 lesions) and the physiology group (111 patients, 159 lesions). Immediate post-PCI physiology results were deemed suboptimal in 22 (17%) cases, and operators performed further optimization steps. Final post-PCI results were resting distal coronary pressure to aortic pressure ratio of 0.95±0.04, the diastolic pressure ratio of 0.94±0.06, and the fractional flow reserve of 0.90±0.07. Ultimately, 9 lesions (7%) remained with fractional flow reserve values ≤0.80. At 18-month follow-up, target vessel failure was 17.4% in the angiography group and 18% in the physiology group (P=0.88). Rates of cardiac death (1% versus 0%; P=0.32), myocardial infarction (13% versus 11%; P=0.66), and target vessel revascularization (4% versus 7%; P=0.24) remained similar in both groups. No difference in angina score, medication, or quality of life was found.

CONCLUSIONS

In all-comers patients undergoing uncomplicated PCI, routine post-PCI physiology assessment was not associated with clinical benefit compared with standard angiographic guidance. Further study is required to determine how post-PCI physiology guidance can be helpful in selected lesions.

REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT04929496.