Impact of Access Site on Periprocedural Bleeding, Cerebrovascular, and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial

Background The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring coronary intervention is based on evidence suggesting that TRA is associated with less bleeding and vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing both access routes in a patient population with atrial fibrillation undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. Methods Using data from the RIVA-PCI registry, which includes atrial fibrillation patients undergoing PCI, we analyzed a high-bleeding-risk cohort. These patients were predominantly on oral anticoagulation (OAC) for atrial fibrillation and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). Results Out of 1636 patients, 854 (52.2%) underwent transfemoral access (TFA), while 782 (47.8%) received the procedure via transradial access (TRA), including nine patients with brachial artery puncture. Mean age was 75.5 years. Groups were similar in terms of age, sex distribution, atrial fibrillation type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with GFR<60 ml/min in the TFA group. Clinically relevant differences in antithrombotic therapy and combinations at the time of PCI were absent. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p<0.05; UAP 21.5% vs. 14.5%, p<0.05), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p<0.05). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p=0.93), but TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p<0.05), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p<0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p=0.93; TFA 0.4% vs. TRA 0.1%, p=0.36). Conclusions In high-bleeding-risk (HBR) patients with atrial fibrillation (AF) undergoing PCI for acute or chronic coronary syndrome, utilizing radial access (TRA) resulted in a significant decrease of in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This research received no specific funding from any external sources. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The ethics committee of Landesaerztekammer Rheinland-Pfalz (Germany) gave ethical approval for this work (no. 837.448.17). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data used in this study are available upon request. However, due to privacy and ethical considerations, access to the data is subject to approval from the appropriate regulatory bodies and the RIVA-PCI Trial investigators.