BACKGROUND
International guidelines recommend a dual antithrombotic therapy (DAT) with direct oral anticoagulant (DOAC) for patients on chronic oral anticoagulant therapy (OAT) undergoing percutaneous coronary intervention with stent implantation (PCI-S). However, the implementation of practice Guidelines in the “real world” is often a complex exercise. Aim of the multicenter prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) registry was to evaluate the management of the different antithrombotic regimens strategies in patients with an indication for OAT undergoing PCI-S in a “real world” setting and its association with clinical outcomes.
METHODS
The PERSEO registry has been designed to enrol patients requiring OAT and treated by PCI-S in 25 Italian Cardiology Centres. No exclusion criteria have been defined. The primary end-point was a combined measure of efficacy and safety outcome (NACE), including major bleeding events + major adverse cardiac and cerebral events at one year follow up in patients treated with DOAC compared to vitamin K antagonists.
RESULTS
From February 2018 to February 2022, a total of 1233 patients were enrolled: mean age 74±9 years, 900 males and 333 females. The primary indication for OAT was atrial fibrillation (1066 patients, 87%) while an acute coronary syndrome was the leading reason for PCI-S (789 patients, 64%). Of those, 271 patients had an ST elevation myocardial infarction at admission. Mean CHA2DVAS2C score and HASBLED score were respectively 4±2 and 4±1. Six patients died during hospitalization and 1227 were discharged alive: 1027 on triple antithrombotic therapy (oral anticoagulant and dual antiplatelet therapy), 196 patients on DAT (oral anticoagulant and single antiplatelet therapy) and 4 patients on oral anticoagulant alone. The majority of patients enrolled were discharged on DOAC (1006 patients, 82%), whereas only a minority received vitamin K antagonists (221 patients, 18%).
CONCLUSION
The Italian PERSEO Registry is the largest prospective observational study comparing different antithrombotic strategies in patients with an indication for OAT undergoing PCI-S in a “real world” setting. Baseline characteristics, depicted a population at high thrombotic and haemorrhagic risk. In agreement with current guidelines the majority of patients were discharged on DOAC, yet the use of a DAT was still limited to a minority of the patients included.