Key result
Post-procedural caFFR ≤0.87 after paclitaxel-coated balloon angioplasty for ISR linked to ~53% greater VoCE risk.
Why the study?
The clinical impact of computational pressure-flow dynamics derived FFR (caFFR) after paclitaxel-coated balloon angioplasty remained unclear.
Does post-procedural computational pressure-flow dynamics derived FFR (caFFR) predict 3-year vessel-oriented composite endpoints in patients undergoing paclitaxel-coated balloon angioplasty for in-stent restenosis?
Cohort
No
Does post-procedural computational pressure-flow dynamics derived FFR (caFFR) predict 3-year vessel-oriented composite endpoints in patients undergoing paclitaxel-coated balloon angioplasty for in-stent restenosis?
Effect estimate: HR 0.72 (per 0.1 increase) (95% CI 0.53-0.98)
p-value: p=0.039
Post-procedural caFFR is a superior predictor of 3-year vessel-oriented clinical outcomes compared to percent diameter stenosis after paclitaxel-coated balloon angioplasty for in-stent restenosis, with a target value of >0.87.
Background The clinical impact of angiography‐based, computational pressure‐flow dynamics derived FFR (caFFR) after paclitaxel‑coated balloon (DCB) angioplasty remains unclear. Aims To investigate the prognostic value of post‐procedural caFFR in the treatment of in‐stent restenosis (ISR) with DCB. Methods 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. Results 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). Conclusions 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. Trial Registration: Clinicaltrial.gov identifier: NCT05133921
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Yang et al. (2026) conducted a cohort in In-stent restenosis (ISR). Post-procedural computational pressure-flow dynamics derived FFR (caFFR) vs. Higher caFFR values was evaluated on Vessel-oriented composite endpoint (VoCE) at 3 years (HR 0.72 (per 0.1 increase), 95% CI 0.53-0.98, p=0.039). Post-procedural caFFR ≤0.87 after paclitaxel-coated balloon angioplasty for in-stent restenosis increased the risk of vessel-oriented composite endpoint (HR 1.53; 95% CI 1.02-2.29).
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