Abstract

Background: The optimal medication therapy for patients with angiographically intermediate coronary artery stenosis in whom revascularization was deferred by fractional flow reserve (FFR) remains to be fully established. The aim of this study was to investigate the long-term outcomes of continuous statin therapy in those patients. Methods: This sub-analysis of the J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry) included 1113 patients who have completed 2-year follow-up and were divided into 2 groups according to continuation of statin treatment. Landmark analyses were performed that compared treatments during the follow-up period between 2 years and 5 years to assess the composite endpoints, including target vessel failure and non-cardiac death in the Cox proportional hazard regression with mixed effects account for institutional variety and inverse probability of treatment weighting (IPTW) analyses. Target vessel failure was defined as cardiac death, target-vessel related myocardial infarction, and clinically driven target vessel revascularization. Results: By the start of the landmark at 2-year, 681 (61.2%) patients had continued the statin, whereas 432 (38.8%) had not continued. Composite endpoint was observed in 68 (10.0%) patients with continuous statin and 54 (12.5%) in those with discontinuous statin. The multivariate mixed effects Cox regression model and IPTW adjusted for baseline characteristics, comorbidity, FFR value, culprit vessel, and medication revealed that the continuous statin was not associated with a low risk of composite endpoint (HR: 0.81, 95% CI: 0.54 to 1.21, HR: 0.81, 95% CI: 0.62 to 1.05, respectively). Subgroup analysis showed significant interaction between sex, prior myocardial infarction (pMI) and the continuous statin, indicating that the continuous statin therapy was associated with a low risk of composite endpoint in male (HR: 0.62, 95% CI: 0.41, 0.93) and patients with pMI (HR: 0.42, 95% CI 0.22, 0.82). Conclusions: The present study showed that continuous statin therapy was not associated with better long-term outcomes in patients with deferral of coronary intervention based on FFR.

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