PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy

• Conditions: Chronic Stable Angina; Unstable Angina; Acute Myocardial Infarction

• Registration Number: NCT03392948
• Lead Sponsor: Italian Society of Invasive Cardiology

Brief Summary

Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. There are many possible different combinations of the antithrombotic therapy after stent implantation in these patients.

Aim of this observational study is to evaluate the real world antithrombotic treatment in patients requiring anticoagulant therapy undergoing stent implantation and to compare the clinical outcome of patients treated with new oral anticoagulant drugs compared to warfarin.

The study is prospective, performed in different Italian hospitals and aimed to enroll 1080 patients with a 1 year follow up

Detailed Description

Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. These patients pose particular problems when undergo percutaneous coronary intervention with stent implantation (PCI-S), because of the different antithrombotic and oral anticoagulant (OAC) strategies required after the procedure when dual antiplatelet therapy is recommended. Consequently, this scenario requires careful consideration balancing bleeding, stroke and acute coronary syndrome risks.

New oral anticoagulants (NOAC) have been compared to warfarin for stroke prevention in the setting of atrial fibrillation and all these drugs showed a similar or improved efficacy over warfarin in term of ischemic events as well as bleeding complications reduction. In particular, an important safety issue is the reduction of intracranial bleeding compared to warfarin. Currently, four different NOAC have been approved for the treatment of patients with atrial fibrillation: apixaban, edoxaban, rivaroxaban and dabigatran. The first three drugs are anti Xa inhibitors whereas the last one is a direct thrombin inhibitor.

Data regarding the combination of NOAC and antiplatelet therapy after PCI-S in patients requiring chronic anticoagulant therapy are currently scarce.

The aim of our study is to perform a prospective, multicenter, observational, controlled study on patients requiring chronic anticoagulant treatment with either vitamin K antagonists or NOAC undergoing PCI-S for concomitant coronary disease.

The primary objectives of the study are:

1. To describe the contemporary antithrombotic management during and post PCI-S in patients treated with oral anticoagulant therapy

2. To evaluate, in this context, the efficacy and safety of the different NAOC compared to warfarin regimens.

According to the observational design of the study, anticoagulant therapy (vitamin antagonists or new oral anticoagulant drugs), other pharmacological therapy as well as procedural device utilized, before, during the procedure and at follow-up will be left to the physician decision.

The events will be adjudicated by a clinical event committee (CEC) comprised of qualified physicians. The CEC is responsible for adjudicating all potential endpoint events, including death, bleeding, myocardial infarction, stent thrombosis, stroke, and coronary revascularization

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Study Start: 2018-02-09
• Primary Completion: 2022-02-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1080

Inclusion Criteria

• All patients undergoing percutaneous coronary interventions with stent and an indication for chronic anticoagulant therapy.

Exclusion Criteria

• Patients of age < 18 years old
• Lack of written informed consent to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Event	1 year	major bleeding, myocardial infarction, death, stroke, myocardial revascularization

Trial Locations

Locations (10)

Ospedale Maggiore Carlo Alberto Pizzardi; 🇮🇹 Bologna, BO, Italy

Ospedale della Misericordia; 🇮🇹 Grosseto, GR, Italy

Ospedale Sandro Pertini; 🇮🇹 Roma, Italy

Azienda Ospedaliero - Universitaria "Mater Domini"; 🇮🇹 Catanzaro, CZ, Italy

A.O.U. Policlinico "G.Martino" - Messina; 🇮🇹 Messina, ME, Italy

Ospedale Civile SS Annunziata; 🇮🇹 Sassari, SS, Italy

Ospedale "Vito Fazzi"; 🇮🇹 Lecce, Italy

Ospedale S. Eugenio; 🇮🇹 Roma, Italy

Ospedale "Infermi" di Rimini; 🇮🇹 Rimini, Italy

Ospedale SS Filippo e Nicola; 🇮🇹 Avezzano, Italy