Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Patients requiring chronic oral anticoagulant therapy undergoing PCI with stent implantation (n=1080). Intervention: Direct oral anticoagulant (DOAC) vs. Vitamin K antagonists. Primary outcome: Combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up.

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

doi:10.2459/jcm.0000000000001372

Key result

The PERSEO Registry is designed to evaluate the 1-year safety and efficacy of DOACs versus vitamin K antagonists in a target of 1,080 patients requiring oral anticoagulation who undergo PCI.

Why the study?

Randomized trials demonstrate advantages for double antithrombotic therapy and DOACs over warfarin after PCI with stenting, but real-world data in patients requiring chronic OAC remain limited.

Does DOAC compared to VKA improve net adverse clinical events in patients requiring OAC who undergo PCI-S?

Study Design

Type

Observational (n=1,080)

Multicenter

Yes

Structured PICO

Does DOAC compared to VKA improve net adverse clinical events in patients requiring OAC who undergo PCI-S?

P

Population

A target of at least 1,080 patients requiring oral anticoagulant therapy who undergo percutaneous coronary intervention with stent implantation, followed for 1 year.

E

Exposure

Direct oral anticoagulant (DOAC) combined with dual or triple antiplatelet therapy

C

Comparator

Vitamin K antagonists combined with corresponding antiplatelet strategies

O

Outcome

Net Adverse Clinical Events (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-upcomposite

Implication

The PERSEO Registry is designed to evaluate the real-world safety and efficacy of DOACs versus VKAs and dual versus triple antithrombotic therapy in patients requiring OAC who undergo PCI with stenting.

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.

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Cite This Study

Sciahbasi et al. (2022) conducted an observational in Patients requiring chronic oral anticoagulant therapy undergoing PCI with stent implantation (n=1,080). Direct oral anticoagulant (DOAC) vs. Vitamin K antagonists was evaluated on Combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up. The PERSEO Registry is designed to evaluate the 1-year safety and efficacy of DOACs versus vitamin K antagonists in a target of 1,080 patients requiring oral anticoagulation who undergo PCI.

synapsesocial.com/papers/6a9800ae1c3df0a36e8bd851 https://doi.org/10.2459/jcm.0000000000001372