Non-randomized comparison between revascularization and deferral for intermediate coronary stenosis with abnormal fractional flow reserve and preserved coronary flow reserve

Abstract

Limited data are available regarding comparative prognosis after percutaneous coronary intervention (PCI) versus deferral of revascularization in patients with intermediate stenosis with abnormal fractional flow reserve (FFR) but preserved coronary flow reserve (CFR). From the International Collaboration of Comprehensive Physiologic Assessment Registry (NCT03690713), a total of 330 patients (338 vessels) who had coronary stenosis with FFR ≤ 0.80 but CFR > 2.0 were selected for the current analysis. Patient-level clinical outcome was assessed by major adverse cardiac events (MACE) at 5 years, a composite of all-cause death, target-vessel myocardial infarction (MI), or target-vessel revascularization. Among the study population, 231 patients (233 vessels) underwent PCI and 99 patients (105 vessels) were deferred. During 5 years of follow-up, cumulative incidence of MACE was 13.0% (31 patients) without significant difference between PCI and deferred groups (12.7% vs. 14.0%, adjusted HR 1.301, 95% CI 0.611-2.769, P = 0.495). Multiple sensitivity analyses by propensity score matching and inverse probability weighting also showed no significant difference in patient-level MACE and vessel-specific MI or revascularization. In this hypothesis-generating study, there was no significant difference in clinical outcomes between PCI and deferred groups among patients with intermediate stenosis with FFR ≤ 0.80 but CFR > 2.0. Further study is needed to confirm this finding.Clinical Trial Registration: International Collaboration of Comprehensive Physiologic Assessment Registry (NCT03690713; registration date: 10/01/2018).

Conflict of interest statement

Dr. Joo Myung Lee received a Research Grant from St. Jude Medical (Abbott Vascular) and Philips Volcano. Dr. Bon-Kwon Koo received an Institutional Research Grant from St. Jude Medical (Abbott Vascular) and Philips Volcano. All other authors declare that there is no conflict of interest relevant to the submitted work.

Figures

Figure 1

Study flow. From the international cohort of 3 prospective registries, 330 patients (338 vessels) with abnormal FFR ≤ 0.80 but preserved CFR > 2.0 were included in the current study. CFR Coronary flow reserve, FFR Fractional flow reserve, PCI Percutaneous coronary intervention.

Figure 2

Association between FFR and CFR. The association between FFR and CFR among patients with FFR ≤ 0.80 and CFR > 2.0 is shown. CFR Coronary flow reserve, FFR Fractional flow reserve.

Figure 3

Comparison of major adverse cardiac events according to treatment strategy. Kaplan–Meier curves and cumulative incidence of MACE (and its individual components) were compared according to the treatment strategies (PCI or deferral of revascularization). Adjusted HR and 95% CI were calculated based on multivariable Cox proportional hazard regression model. Adjusted variables included age, sex, diabetes mellitus, hypertension, hypercholesterolemia, current smoking, and presentation with acute coronary syndrome. CI Confidence interval, HRadj Adjusted hazard ratio, MACE Major adverse cardiac event, MI Myocardial infarction, PCI Percutaneous coronary intervention.

Figure 4

Subgroup analysis for major adverse cardiac events. Comparison of major adverse cardiac event according to treatment strategy (PCI or deferral of revascularization) was performed within various subgroups. Adjusted HR and 95% CI were calculated based on multivariable Cox proportional hazard regression model. Adjusted variables included age, sex, diabetes, hypercholesterolemia, current smoking, and presentation with acute coronary syndrome, as appropriate. CFR Coronary flow reserve, CI Confidence interval, DM Diabetes mellitus, FFR Fractional flow reserve, HLD Hyperlipidemia (hypercholesterolemia), HR Hazard ratio, PCI Percutaneous coronary intervention.