Abstract

Abstract Background Low fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with procedural factors in the stented segment and residual disease in the non-stented segment. Even the prognostic value of post-PCI FFR has been reported, its long-term clinical relevance has not been thoroughly investigated. Purpose We sought to investigate the long-term prognostic value of post-PCI FFR and its relative significance on future events in stented and non-stented segments. Methods The International Post-PCI FFR extended registry (NCT04684043) followed the 2,200 patients who underwent PCI and measured post-PCI FFR between June 2011 and May 2018. The primary outcome was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (TVMI), and target vessel revascularization (TVR) at 5 years. The secondary outcomes were a composite of cardiac death or TVMI at 5 years. Results The median value of post-PCI FFR of target vessels was 0.89 (IQR 0.84-0.93). The optimal cut-off value of post-PCI FFR for predicting TVF was 0.81, and that for predicting cardiac death or TVMI was 0.76, respectively. The cumulative incidence of TVF was significantly higher in the low post-PCI group (20.5%) than in the high post-PCI FFR group (10.3%) (adjusted hazard ratio [HR] 2.11, 95% confidence interval [CI] 1.56-2.86, p<0.001). The cumulative incidence of cardiac death or TVMI was also significantly higher in the low post-PCI FFR group (7.3%) than in the high post-PCI FFR group (3.2%) (adjusted HR 2.34, 95% CI 1.12-4.91, p=0.024). Landmark analysis at 2 years showed that the impact of post-PCI FFR on TVF was consistently found during the first 2 years (adjusted HR of low post-PCI FFR 2.22, 95% CI 1.54-3.21, p<0.001) and thereafter (adjusted HR of low post-PCI FFR 1.96, 95% CI 1.14-3.36, p<0.001). However, the impact of post-PCI FFR on cardiac death or TVMI was more significant after 2 years of follow-up (adjusted HR of low post-PCI FFR 2.01, 95% CI 0.66-6.11, p=0.217 for the first 2 years and adjusted HR of low-post PCI FFR 2.81, 95% CI 1.04-7.60, p=0.042). The cumulative incidence of TVR was 9.5% for 5 years, and 61.0% of TVRs occurred in the stented segment. However, the proportion of TVRs in the non-stented segment increased along with the decrease of post-PCI FFR (35.3% in post-PCI FFR more than 0.90, 34.1% in post-PCI FFR 0.81-0.90, 43.8% in post-PCI FFR 0.71-0.80, and 66.7% in post-PCI FFR 0.70 and less than 0.70, p-for trend<0.001). Conclusions The long-term outcome results of the Internation Post-PCI FFR Extended registry showed that the prognostic impact of post-PCI FFR on TVF was consistently found along with the follow-up. However, that of post-PCI FFR on cardiac death or TVMI was more prominent during the late period of follow-up. In addition, clinical event distribution was different according to post-PCI FFR values.

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