1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE Registry

Abstract

Objectives: The 1-year data from the international ADVANCE (Assessing Diagnostic Value of Non-invasive FFR_CT in Coronary Care) Registry of patients undergoing coronary computed tomography angiography (CTA) was used to evaluate the relationship of fractional flow reserve derived from coronary CTA (FFR_CT) with downstream care and clinical outcomes.

Background: Guidelines for management of chest pain using noninvasive imaging pathways are based on short- to intermediate-term outcomes.

Methods: Patients (N = 5,083) evaluated for clinically suspected coronary artery disease and in whom atherosclerosis was identified by coronary CTA were prospectively enrolled at 38 international sites from July 15, 2015, to October 20, 2017. Demographics, symptom status, coronary CTA and FFR_CT findings and resultant site-based treatment plans, and clinical outcomes through 1 year were recorded and adjudicated by a blinded core laboratory. Major adverse cardiac events (MACE), death, myocardial infarction (MI), and acute coronary syndrome leading to urgent revascularization were captured.

Results: At 1 year, 449 patients did not have follow-up data. Revascularization occurred in 1,208 (38.40%) patients with an FFR_CT ≤0.80 and in 89 (5.60%) with an FFR_CT >0.80 (relative risk [RR]: 6.87; 95% confidence interval [CI]: 5.59 to 8.45; p < 0.001). MACE occurred in 55 patients, 43 events occurred in patients with an FFR_CT ≤0.80 and 12 occurred in those with an FFR_CT >0.80 (RR: 1.81; 95% CI: 0.96 to 3.43; p = 0.06). Time to first event (all-cause death or MI) occurred in 38 (1.20%) patients with an FFR_CT ≤0.80 compared with 10 (0.60%) patients with an FFR_CT >0.80 (RR: 1.92; 95% CI: 0.96 to 3.85; p = 0.06). Time to first event (cardiovascular death or MI) occurred cardiovascular death or MI occurred more in patients with an FFR_CT ≤0.80 compared with patients with an FFR_CT >0.80 (25 [0.80%] vs. 3 [0.20%]; RR: 4.22; 95% CI: 1.28 to 13.95; p = 0.01).

Conclusions: The 1-year outcomes from the ADVANCE FFR_CT Registry show low rates of events in all patients, with less revascularization and a trend toward lower MACE and significantly lower cardiovascular death or MI in patients with a negative FFR_CT compared with patients with abnormal FFR_CT values. (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Wave [ADVANCE]; NCT02499679).

Keywords: FFR(CT); clinical outcomes; clinical practice; coronary computed tomography angiography; fractional flow reserve; major adverse cardiac events.