Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent. Issue 11 (7th November 2022)

• Record Type: Journal Article
• Authors: Sciahbasi, Alessandro; Gargiulo, Giuseppe; Talarico, Giovanni Paolo; Cesaro, Arturo; Zilio, Filippo; De Rosa, Salvatore; Talanas, Giuseppe; Tebaldi, Matteo; Andò, Giuseppe; Rigattieri, Stefano; Misuraca, Leonardo; Cortese, Bernardo; Imperadore, Ferdinando; Lucci, Valerio; Guiducci, Vincenzo; Renda, Giulia; Zezza, Luigi; Versaci, Francesco; Giannico, Maria Benedetta; Caruso, Marco; Spaccarotella, Carmen; Calabrò, Paolo; Esposito, Giovanni; Tarantini, Giuseppe; Musumeci, Giuseppe; Rubboli, Andrea
• Is Part Of: Journal of cardiovascular medicine. Volume 23:Issue 11(2022)
• Page Start: 738
• Page End: 743
• Publication Date: 2022-11-07
• Subjects: atrial fibrillation -- direct oral anticoagulant -- percutaneous coronary intervention -- stent; Cardiology -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; Cardiology -- Periodicals; Cardiovascular Diseases -- Periodicals; 616.1005
• DOI: 10.2459/JCM.0000000000001372
• Languages: English
• ISSNs: 1558-2027

Abstract

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.