Prognostic Value of Computational Pressure-Flow Dynamics Derived FFR Measured Immediately After Successful...

The clinical impact of angiography-based, computational pressure-flow dynamics derived FFR (caFFR) after paclitaxel‑coated balloon (DCB) angioplasty remains unclear.

To investigate the prognostic value of post-procedural caFFR in the treatment of in-stent restenosis (ISR) with DCB.

Consecutive patients undergoing DCB angioplasty for ISR at Xijing Hospital, China, between December 2015 and December 2019 were prospectively enrolled. The primary endpoint was vessel-oriented composite endpoint (VoCE), defined as a composite of vessel-related cardiovascular death, target-vessel myocardial infarction (TV-MI), and ischemia-driven target vessel revascularization (ID-TVR) at 3-year, assessed at the vessel level.

A total of 1055 vessels treated with DCB were screened, and the post-procedural caFFR was analyzable in 999 (94.7%). At 3-year, 149 VoCE (14.9%) and 98 ID-TVR (9.8%) events occurred. Maximally-selected log-rank statistics respectively identified post-procedural caFFR value of 0.87 and post-procedural %DS of 28 as the optimal cutoff points to predict VoCE. Post-procedural caFFR demonstrates the superior predictive ability for VoCE compared to post-procedural %DS (NRI: 7.4%, p < 0.001). A negative correlation was discerned between post-procedural caFFR value and VoCE (HR_{per 0.1 increase}: 0.72, 95% CI: 0.53-0.98, p = 0.039). Post-procedural caFFR ≤ 0.87 group was associated with a 1.5-fold increase in the risk of VoCE (HR_IPTW: 1.53, 95% CI: 1.02-2.29) and a 1.8-fold increase in ID-TVR (HR_IPTW: 1.82, 95% CI: 1.15-2.89).

A higher post-procedural caFFR value is associated with improved vessel-related clinical outcomes in patients of ISR treated by DCB. Achieving a post-procedural caFFR value of 0.87 in the treated vessels may represent a reasonable procedural goal.

Clinicaltrial.gov identifier: NCT05133921.