Clinical outcomes following fractional flow reserve-guided revascularization using nicorandil versus conventional hyperemic agents: insights from the J-PRIDE Registry

The diagnostic accuracy of nicorandil for fractional flow reserve (FFR) measurement has been validated, whereas data on outcomes of FFR-guided revascularization strategy using nicorandil remain limited. This study aimed to compare clinical outcomes following FFR-guided strategy using nicorandil versus conventional hyperemic agents, such as adenosine or papaverine. From the J-PRIDE registry, 2369 patients (3295 lesions) and 831 patients (1009 lesions) were classified into the nicorandil and non-nicorandil groups, respectively. The primary study endpoint was the cumulative 1-year incidence of target vessel failure (TVF; a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization) on a lesion basis. Patients with multivessel disease, aortic stenosis, and severe angiographic stenosis were more likely to receive nicorandil. Overall, the cumulative 1-year incidence of TVF did not differ significantly between the nicorandil and non-nicorandil groups (3.2% versus 2.4%; adjusted hazard ratio [aHR]: 1.23; 95% confidence interval [CI]: 0.78-1.94; P = 0.37). Similarly, in both the deferred and revascularized population, the 1-year TVF rate was comparable between the two groups (2.9% versus 2.5%; aHR: 1.07; 95% CI: 0.62-1.86; P = 0.80; 3.6% versus 2.1%; aHR: 1.35; 95% CI: 0.58-3.11; P = 0.48, respectively). A significant interaction was observed only between the effect of nicorandil on TVF and hemodialysis (P for interaction = 0.028). The 1-year TVF rate was comparable between the nicorandil and non-nicorandil groups, supporting the clinical applicability of nicorandil for FFR measurement in clinical practice.