Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent
Alessandro Sciahbasi, Giuseppe Gargiulo, Giovanni Paolo Talarico, Arturo Cesaro, Filippo Zilio, Salvatore De Rosa, Giuseppe Talanas, Matteo Tebaldi, Giuseppe Andò, Stefano Rigattieri, Leonardo Misuraca, Bernardo Cortese, Ferdinando Imperadore, Valerio Lucci, Vincenzo Guiducci, Giulia Renda, L. Zezza, Francesco Versaci, Maria Benedetta Giannico, Marco Caruso, Carmen Spaccarotella, Paolo Calabrò, Giovanni Esposito, Giuseppe Tarantini, Giuseppe Musumeci, Andrea Rubboli
Abstract
AIM: Percutaneous coronary intervention with stent implantation (PCI-S) in patients requiring chronic oral anticoagulant therapy (OAC) is associated with an increased risk of bleeding and ischemic complications. Different randomized studies showed a significant advantage of a double antithrombotic therapy and superiority of direct oral anticoagulant (DOAC) compared with warfarin, but real-world data are limited. Aim is to evaluate the antithrombotic management and clinical outcome of patients with an indication for OAC who undergo PCI-S in a 'real-world' setting. METHODS: The multicentre prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) Registry (ClinicalTrials.gov Identifier: NCT03392948) has been designed to enrol patients requiring OAC treated by PCI-S in 25 Italian centres. A target of at least 1080 patients will be followed for 1 year and data on thromboembolic and bleeding events and changes in antithrombotic therapy will be registered. The primary end point is a combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up in patients treated with DOAC (and dual or triple antiplatelet therapy) compared with the corresponding strategies with vitamin K antagonists. A secondary prespecified analysis has been defined to evaluate NACE in dual versus triple antithrombotic therapy after hospital discharge at 1-year follow-up. CONCLUSION: The PERSEO Registry will investigate in a 'real world' setting the safety and efficacy of DOAC versus warfarin and dual versus triple antithrombotic therapy in patients with indication for oral anticoagulant therapy who undergo PCI-S.