Because of its superior safety profile and improved outcomes, trans-radial percutaneous coronary intervention (TRI) has become the preferred access in percutaneous coronary intervention (PCI) of native coronary disease. This study investigated the impact of TRI on in-hospital outcomes after PCI for coronary artery bypass graft vessels (GV-PCI). We analyzed patients who underwent GV-PCI in 2019–2022 from the Japanese nationwide registry. Patients were categorized into the TRI and trans-femoral PCI (TFI) groups. We assessed the association between TRI and in-hospital outcomes. The primary outcome was a composite of in-hospital death and major bleeding. In this study, 2,295 patients were analyzed.. The primary outcomes occurred in 29 patients (1.3%), including 17 deaths (0.7%). Major bleeding occurred in 12 patients (0.5%), and access site bleeding in 7 patients (0.3%). The TRI group (n = 1,521) showed lower crude rates of the primary outcome (0.9% vs 1.9%, p = 0.039), major bleeding (0.3% vs 1.0%, p = 0.027), and access site bleeding (0.1% vs 0.6%, p = 0.047) compared with the TFI group (n = 774). Univariable logistic regression demonstrated a significant association of TRI with reduced primary outcome (odd ratio [OR] 0.47, 95% confidence interval [CI] 0.22 to 0.98), major bleeding (OR 0.25, 95% CI 0.07 to 0.80), and access site bleeding (OR 0.20, 95% CI 0.03 to 0.94). In the multivariable analysis, TRI was still significantly associated with a decrease in major bleeding events (OR 0.29, 95% CI 0.07 to 0.93). In conclusion, the use of TRI was associated with a reduction in bleeding events when referenced to TFI in the context of GV-PCI.
Revascularization for recurrent ischemia in patients with previous coronary artery bypass graft (CABG) surgery poses numerous challenges because of the high rate of procedural complications and poor outcomes. , As a strategy for repeat revascularization in patients with previous CABG, percutaneous coronary intervention (PCI) is increasingly preferred over redo-CABG. Conversely, in real-world clinical practice, only a fraction of patients undergo PCI for CABG vessels (GV-PCI). Over the past decade, the proportion of trans-radial percutaneous coronary intervention (TRI) has increased with a lower rate of procedural complications and improved cardiovascular outcomes than trans-femoral percutaneous coronary intervention (TFI). , However, successful TRI requires experience and expertise, particularly in complex GV-PCI cases. In addition, the evidence of TRI cannot be directly applied to GV-PCI because patients with previous CABG are often excluded from clinical trials comparing the outcomes of different access routes. To date, there has been limited data on the efficacy of TRI for GV-PCI. This study aimed to investigate the impact of TRI on in-hospital outcomes in GV-PCI using the nationwide PCI registry in Japan (J-PCI registry), one of the largest healthcare procedural databases with approximately 200,000 cases registered annually.
Methods
The J-PCI registry is a prospective and multicenter Japanese nationwide PCI registry, which is operated by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT), designed to collect data on the clinical characteristics and in-hospital outcomes of patients who underwent PCI. , Since 2013, the J-PCI registry has been incorporated into the National Clinical Data System, a nationwide prospective web-based registration system. Each hospital has a data manager responsible for collecting PCI data and submitting it to a dedicated online database. To ensure the quality and accuracy of data collection, CVIT organizes annual meetings for data managers and conducts random site visits for data validation. The protocol of the J-PCI registry was approved by the Institutional Review Board Committee at the Network for Promotion of Clinical Studies in a specified nonprofit organization affiliated with the Osaka University Graduate School of Medicine. Because of the retrospective design of the study, the requirement for written informed consent was waived.
This study analyzed patients who underwent GV-PCI in the J-PCI registry between January 2019 and December 2022. Patients under dialysis, the presence of shock or cardiopulmonary arrest within 24 hours before PCI, the use of mechanical circulatory support (intra-aortic balloon pump, venoarterial extracorporeal membrane oxygenation, Impella, and left ventricular assist device), being neither TRI nor TFI and missing data in baseline covariates were excluded.
The definitions of J-PCI variables were summarized in a previous report. In brief, acute coronary syndrome (ACS) encompasses ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina. Chronic kidney disease (CKD) was defined as the presence of proteinuria, serum creatinine ≥1.3 mg/100 ml, or an estimated glomerular filtration rate ≤60 ml/min/1.73 m 2 by referring to the Japanese Society of Nephrology guideline. The outcomes analyzed in this study were in-hospital death, bleeding complications, and procedure-related complications. The primary outcome was defined as a composite of in-hospital death and major bleeding complications. Major bleeding complications were defined as peri- and post-procedural bleeding requiring blood transfusion from access and non-access sites. Procedure-related complications included cardiac tamponade, cardiogenic shock requiring mechanical and/or inotropic support, stent thrombosis, and emergent cardiac surgery.
Categorical variables were presented as numbers with relative percentages and compared using chi-square tests and Fisher’s exact tests as appropriate. Continuous variables were presented as mean ± SD and compared using t tests. We performed univariable and multivariable logistic regression analyses to assess the association between TRI with the primary outcome and other in-hospital outcomes. The variables adjusted in the multivariable analysis included age, gender, ACS presentation, and the presence of CKD and peripheral artery disease. Differences were considered significant for two-sided p Values <0.05. All data were analyzed using R statistical software version 4.0.2 (R Foundation for Statistical Computing, Vienna, Austria).
Results
The flow chart of the patient enrollment is shown in Figure 1 . During the study period, GV-PCI (n = 3,566) cases constituted a very small proportion (0.4%) of the total PCI procedures (n = 972,370). After removing patients with exclusion criteria, we analyzed 2,295 patients who underwent GV-PCI in this study. Figure 2 illustrates the institutional variability of the average annual number of GV-PCI procedures, highlighting the small number of GV-PCI cases per hospital. Notably, 68% of hospitals experienced fewer than 1 case per year on average. Baseline patient characteristics between the TRI and TFI groups are listed in Table 1 . TRI (n = 1,521) was more commonly performed than TFI (n = 774) in GV-PCI procedures. Patients with TRI were older than those with TFI (75.1 ± 9.14 vs 73.9 ± 9.85). The TRI group exhibited a lower prevalence of female (18% vs 23%), hypertension (82% vs 85%), CKD (31% vs 36%), history of heart failure (31% vs 36%), ACS (34% vs 43%), acute heart failure within 24 hours (2% vs 5%), emergent PCI (19% vs 28%), and arterial graft PCI (20% vs 26%). In both groups, over 30% of patients had completed PCI with drug-coated balloons.
| Variables | TRI (n = 1,521) | TFI (n = 774) | P value |
|---|---|---|---|
| Age, years | 75.1 ± 9.14 | 73.9 ± 9.85 | 0.004 |
| Female | 276 (18%) | 177 (23%) | 0.008 |
| Hypertension | 1,239 (82%) | 658 (85%) | 0.039 |
| Diabetes | 847 (56%) | 453 (59%) | 0.21 |
| Hyperlipidemia | 1,242 (82%) | 643 (83%) | 0.44 |
| Smoker | 371 (24%) | 175 (23%) | 0.37 |
| CKD | 465 (31%) | 282 (36%) | 0.005 |
| COPD | 60 (4%) | 26 (3%) | 0.56 |
| PAD | 196 (13%) | 114 (15%) | 0.25 |
| Prior MI | 730 (48%) | 399 (51.6%) | 0.12 |
| Prior HF | 467 (31%) | 275 (36%) | 0.022 |
| Preprocedural antiplatelet therapy | 1,482 (97%) | 742 (96%) | 0.054 |
| Preprocedural anticoagulants | 350 (23%) | 167 (22%) | 0.44 |
| Clinical presentation | < 0.001 | ||
| ACS | 512 (34%) | 331 (43%) | |
| Non-ACS | 1,009 (66%) | 443 (57%) | |
| Acute heart failure within 24 h | 32 (2%) | 37 (5%) | < 0.001 |
| Emergent PCI | 295 (19%) | 214 (28%) | < 0.001 |
| Graft | 0.005 | ||
| Saphenous vein | 1,211 (80%) | 576 (74%) | |
| Arterial graft | 310 (20%) | 198 (26%) | |
| DES use | 938 (62%) | 451 (58%) | 0.13 |
| DCB use | 508 (33%) | 274 (35%) | 0.36 |
| Distal protection use | 181 (12%) | 76 (10%) | 0.15 |
Overall, the primary outcome was observed in 29 patients (1.3%). There were 17 deaths (0.7%) in the study population. Major bleeding occurred in 12 patients (0.5%), including 7 patients (0.3%) with access site bleeding and any complications in 34 patients (1.5%). Table 2 lists the in-hospital clinical outcomes for each group, showing a lower crude rate of the primary outcome in the TRI group (0.9% vs 1.9%, p = 0.039). Additionally, the rates of major bleeding (0.3% vs 1.0%, p = 0.027), access site bleeding (0.1% vs 0.6%, p = 0.047), and any complications (1.1% vs 2.2%, p = 0.043) were lower in the TRI group compared with the TFI group. However, there was no significant difference in mortality rate between the groups.
| Outcomes | TRI (n = 1,521) | TFI (n = 774) | P value |
|---|---|---|---|
| Composite of in-hospital death and all bleeding | 14 (0.9%) | 15 (1.9%) | 0.039 |
| In-hospital death | 10 (0.7%) | 7 (0.9%) | 0.51 |
| Major bleeding | 4 (0.3%) | 8 (1.0%) | 0.027 |
| Access site bleeding | 2 (0.1%) | 5 (0.6%) | 0.047 |
| Non-access site bleeding | 2 (0.1%) | 3 (0.4%) | 0.34 |
| Cardiac tamponade | 0 | 1 (0.1%) | 0.34 |
| Cardiogenic shock requiring mechanical and/or inotropic support | 4 (0.3%) | 4 (0.5%) | 0.46 |
| Stent thrombosis | 0 | 0 | NA |
| Emergent surgery | 0 | 0 | NA |
| Any complications | 17 (1.1%) | 17 (2.2%) | 0.043 |
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