Shoichi Kuramitsu

Background: The prognostic impact of diabetes status on outcomes after physiology-guided revascularization remains unclear. This study evaluated clinical outcomes in patients with insulin-treated diabetes (ITD), non-ITD (NITD), and without diabetes after physiology-guided revascularization.Methods and Results: From the J-PRIDE registry, 3,140 patients were categorized into non-diabetes (n=1,797), NITD (n=1,133), and ITD (n=210) groups. The primary endpoint was the 1-year incidence of target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. The 1-year TVF rate was significantly higher in the ITD and NITD groups than in the non-diabetes group (6.1% and 4.1% vs. 2.0%, respectively), with adjusted hazard ratios for the ITD and NTD groups of 2.14 (95% confidence interval [CI] 1.09–4.19; P=0.027) and 1.63 (95 CI 1.02–2.61; P=0.041), respectively. The non-hyperemic pressure ratio cut-off predicting fractional flow reserve (FFR) ≤0.80 was lower in the ITD than NITD and non-diabetes groups (0.87 vs. 0.89 and 0.90, respectively). The ITD group had the highest risk of TVF across all FFR values, followed by the NITD and non-diabetes groups.Conclusions: Patients with ITD and NITD exhibit worse clinical outcomes than those without diabetes. Notably, patients with ITD remained at elevated risk across the entire FFR spectrum, suggesting that physiological severity alone may not fully capture their residual cardiovascular risk.

Background: Robotic-assisted percutaneous coronary intervention (rPCI) offers potential benefits, including improved lesion assessment, optimised stent deployment and reduced radiation exposure. However, comparative data, particularly in Japanese populations, remain limited. Aim: To compare procedural and clinical outcomes between second-generation rPCI and manual percutaneous coronary intervention (mPCI) in patients with chronic coronary syndrome and acute coronary syndrome over a 1-year follow-up period. Methods: This retrospective cohort study included 176 patients who underwent rPCI using the second-generation CorPath GRX Vascular Robotic System. Following 1:1 propensity score matching at the lesion level, 176 patients were identified in the mPCI group. The co-primary endpoints were 1-year all-cause mortality and major adverse cardiovascular events, defined as a composite of cardiac death, non-fatal MI, target lesion revascularisation, stent thrombosis and stroke. Results: Both groups had similar baseline characteristics. Compared with mPCI, rPCI was associated with shorter total procedural time (26 minutes [19–37] versus 71 minutes [52–90]; p<0.01), fluoroscopy time (14 minutes [10–18] versus 16 minutes [10–26]; p=0.04), lower contrast volume (99 [82.8–129.0] versus 141 ml [116–172]; p<0.01) and lower dose area product (3,628.3 [2,552.1–5,352.3] versus 6,349.1 [4,080.0–8,382.3]; p<0.01). At 1 year, the co-primary endpoints of all-cause mortality (p=0.33) and major adverse cardiovascular events (p=0.79) were comparable between groups. Conclusion: Compared with mPCI, rPCI was associated with shorter procedural and fluoroscopy times, lower contrast volume and lower dose area product, while demonstrating similar clinical outcomes at 1 year.

Background: Chronic kidney disease is associated with an increased incidence of stent thrombosis (ST) following drug-eluting stent (DES) implantation, but the clinical outcomes after DES-ST in hemodialysis (HD) patients compared with non-HD patients have not been fully elucidated.Methods and Results: From the REAL-ST registry, we evaluated 655 patients with DES-ST, divided into 2 groups: HD group (n=59) and non-HD group (n=596). The primary endpoint was the cumulative 3-year incidence of all-cause death after the index ST event. Late ST was more prevalent in the HD group, whereas early and very late ST were common in the non-HD group. Following the index ST event, the HD group showed significantly higher 3-year incidences of all-cause death (48.2% vs. 22.9%, P=0.0005), cardiac death (33.4% vs.15.8%, P=0.003) and target lesion revascularization (TLR: 36.2% vs. 17.5%, P=0.0002) compared with the non-HD group. The cumulative 3-year incidence of recurrent ST did not differ significantly between groups (7.3% vs. 5.9%, P=0.88). After multivariable adjustment, HD remained significantly associated with an increased risk of all-cause death (adjusted hazard ratio [aHR], 1.95; 95% confidence interval [CI], 1.25–3.04; P=0.003), cardiac death (aHR, 1.75; 95% CI, 1.02–2.99; P=0.04) and TLR (aHR, 2.63; 95% CI, 1.52–4.57; P<0.001).Conclusions: Compared with non-HD patients, HD patients experienced worse clinical outcomes following their index DES-ST event.

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.

BACKGROUND: The clinical utility of physiology-guided revascularization for decision-making in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) remains uncertain. The aim of this study is to evaluate the diagnostic performance and prognostic significance of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs) according to the severity of CKD. METHODS: This subanalysis of the J-PRIDE registry, a prospective multicenter study conducted at 20 Japanese centers between September 2019 and February 2021, included 4296 lesions from 3194 patients who underwent both FFR and NHPR assessment. Patients were categorized by estimated glomerular filtration rate into non-CKD (≥60 mL/min per 1.73 m ² ; n=1639), CKD (15–59; n=1321), and ESRD (P P =0.001). The NHPR cutoff predicting FFR ≤0.80 was lower in ESRD compared with CKD and non-CKD (0.85 versus 0.89 versus 0.89). Although the overall prevalence of FFR/NHPR discordance was comparable (23.6%, 19.7%, and 19.7%; P =0.24), FFR−/NHPR+ discordance predominated in ESRD (18.6% versus 9.3% versus 7.0%; P <0.001). FFR−/NHPR+ lesions in the ESRD group exhibited an excess risk compared with other lesions. Revascularization was beneficial in non-CKD patients with FFR+/NHPR− lesions, whereas no clear benefit was observed in patients with CKD and ESRD. CONCLUSIONS: Patients with ESRD exhibited distinct physiological characteristics and substantially worse outcomes, highlighting the need for tailored coronary revascularization strategies in this population. REGISTRATION: URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000038403.