Abnormal physiological findings after FFR-based revascularisation deferral are associated with worse prognosis in women

Abstract

The prognostic value of abnormal resting Pd/Pa and coronary flow reserve (CFR) after fractional flow reserve (FFR)-guided revascularisation deferral according to sex remains unknown. From the ILIAS Registry composed of 20 hospitals globally from 7 countries, patients with deferred lesions following FFR assessment (FFR > 0.8) were included. (NCT04485234) The primary clinical endpoint was target vessel failure (TVF) at 2-years follow-up. We included 1392 patients with 1759 vessels (n = 564 women, 31.9%). Although resting Pd/Pa was similar between the sexes (p = 0.116), women had lower CFR than men (2.5 [2.0-3.2] vs. 2.7 [2.1-3.5]; p = 0.004). During a 2-year follow-up period, TVF events occurred in 56 vessels (3.2%). The risk of 2-year TVF was significantly higher in women with low versus high resting Pd/Pa (HR: 9.79; p < 0.001), whereas this trend was not seen in men. (Sex: P-value for interaction = 0.022) Furthermore, resting Pd/Pa provided an incremental prognostic value for 2-year TVF over CFR assessment only in women. After FFR-based revascularisation deferral, low resting Pd/Pa is associated with higher risk of TVF in women, but not in men. The predictive value of Pd/Pa increases when stratified according to CFR values, with significantly high TVF rates in women in whom both indices are concordantly abnormal.Clinical Trial Registration: Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry), NCT04485234.

Figure 1

Kaplan–Meier time to event curves for target vessel failure during 2-year follow-up across the sexes. The 2-year TVF survival free rate was compared across the sex. TVF Target vessel failure.

Figure 2

Kaplan–Meier time to event curves for target vessel failure during 2-year follow-up across the groups defined by normal/abnormal resting Pd/Pa and sex. The 2-year TVF survival free rate was stratified according to sex and resting Pd/Pa. In the risk comparison analyses, women with abnormal resting Pd/Pa showed the highest risk of 2-year TVF. Abbreviations are listed in Fig. 1.

Figure 3

Kaplan–Meier time to event curves for target vessel failure during 2-year follow-up across the groups defined by normal/abnormal resting Pd/Pa and CFR. The 2-year TVF survival free rate was compared across the groups defined by normal/abnormal resting Pd/Pa and CFR in (A) overall cohort, (B) women, and (C) men. CFR Coronary flow reserve. Other abbreviations are listed in Fig. 1.

Figure 4

Comparison of ROC curves for clinical models to predict 2-year target vessel failure. The AUC of the ROC curve was improved by combining CFR and resting Pd/Pa in (A) women, whereas this trend was not seen in (B) men. ROC Receiver-operating characteristic, AUC Area under the curve. Other abbreviations are listed in Fig. 1 and Fig. 3.