Access for percutaneous coronary intervention in ST segment elevation myocardial infarction: radial vs. femoral — a prospective, randomised clinical trial (OCEAN RACE)

Abstract

Percutaneous treatment of patients with ST segment elevation myocardial infarction (STEMI) has become the standard and default mode of management as recommended by the European Society of Cardiology guidelines for managing acute myocardial infarction in patients presenting with STEMI. The choice of vascular access is made by the operator and has a potential impact on the safety and efficacy of the procedure and outcomes. To understand the influence of a radial approach on bleeding complications and angiographic success, we performed a prospective, controlled randomised trial. Patients were allocated to radial (TR) or femoral (TF) vascular access. The primary endpoints were major bleeding by the REPLACE-2 scale and minor bleeding by the EASY scale (TR arm) or the FEMORAL scale (TF arm). Other outcomes included procedural data, in-hospital and long-term survival. There were 103 patients analysed in total, 52 in the TR arm and 51 in the TF arm. The demographic and clinical baseline characteristics were well matched between the two study groups. The frequency of the primary endpoint was the same in both arms (TR: 25.0% vs. TF: 33.3%, p = 0.238). In per protocol analysis, there was a significant benefit of the TR approach among independent operators (17.4% vs. 36.8%, p = 0.038). Major bleeding by the REPLACE-2 scale occurred in 4.2% of patients (TR: 5.8% vs. TF: 3.9%, p = 0.509). There were no differences in terms of the rate of major cardiac adverse events, which happened in 10.7% of the study population (TR: 9.6% vs. TF: 11.8%, p = 0.48). In the TF arm, there was a trend towards a higher risk of local bleedings (TR: 22.4% vs. TF: 37.7%, p = 0.081) and a significantly higher frequency of local haematoma (class III, EASY/FEMORAL) (TR: 0% vs. TF: 9.8%, p = 0.027). There were no significant differences between the TR and TF approaches in terms of clinical efficacy and patient safety. However, patients treated by independent operators might benefit from TR access. The overall complication risk of percutaneous coronary intervention treatment of STEMI patients remains low.