What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.

• Conditions: Atrial Fibrillations; Acute Coronary Syndromes; Coronary Artery Diseases; Stroke; Bleeding; Myocardial Infarction; Heart Valve Prostheses
• Interventions: Drug: Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.

• Registration Number: NCT02635230
• Lead Sponsor: R&D Cardiologie

Brief Summary

The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients current North American and European guidelines recommend a triple therapy strategy, including vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this triple therapy strategy is a significant increase in the risk of major bleeding. Furthermore, the ommitance of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K oral anticoagulants (NOAC), created numerous new antithrombotic treatment strategies for these patients with overlapping conditions. To date, evidence on the risks and benefits of these new antithrombotic treatment strategies is lacking.

The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve prosthesis ánd undergoing coronary revascularisation through a better understanding of their demographics, antithrombotic management and related in-hospital and long-term outcomes. The WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment patterns and patient outcomes.

Objective: To assess the different management patterns and related in-hospital and long-term safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12 inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation.

Detailed Description

The WOEST 2 Registry is a prospective, international, multi-centre, non-interventional, cohort study designed to recruit an unselected cohort of patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation.

Trial overview

Name : WOEST 2 REGISTRY

Target for enrollment : 2200 patients

Time frame for inclusion : within 72 hours after index PCI or coronary artery bypass grafting (CABG)

Follow-up : 24 months

Visits : 30 days, 12 and 24 months after index PCI or CABG

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Status Verified: 2019-09
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria:

1. Patient is ≥ 18 years of age;
2. Patients with a diagnosis of atrial fibrillation (prior to hospitalisation ór during hospitalisation within 72h after coronary revascularisation) and/or with a heart valve prosthesis (aortic/mitral);
3. Chronic treatment with OAC or NOAC therapy at inclusion or the intention to start chronic treatment with OAC or NOAC within 72h after coronary revascularisation AND with intended duration of treatment for at least one year after inclusion in the registry;
4. Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent);
5. Prescription of a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel) because of CABG following acute coronary syndrome* and /or because of PCI (with deployment of at least 1 coronary stent).
6. Patient has provided written informed consent.

Exclusion Criteria

A potential subject who meets ANY of the following criteria will be excluded from participation in this study:

1. Patients unable to sign informed consent (including mental disabled patients);
2. Patients with life expectancy < 1 year;
3. Allergy or intolerance to P2Y12 inhibitors.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic oral anticoagulation and P2Y12 inhibitor	Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.	Patients with chronic indication for chronic oral anticoagulation (OAC) because of a heart valve prosthesis and/or atrial fibrillation undergoing coronary revascularisation (by PCI or CABG) and requiring concomitant treatment with P2Y12 inhibitors.

Primary Outcome Measures

Name	Time	Method
The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome].	1 year	Bleeding will be classified by the Bleeding Academic Research Consortium (BARC) 2, 3, 4 and 5 bleeding criteria and by the Thrombolysis in Myocardial Infarction (TIMI) minor and major bleeding criteria.
Composite of the rate of non-fatal myocardial infarction, non-fatal ischemic stroke (including transient ischemic attack), non-central nervous system systemic embolization and cardiovascular death [the primary efficacy outcome].	1 year

Trial Locations

Locations (9)

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Elizabeth-TweeSteden Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Onze Lieve Vrouw Ziekenhuis; 🇧🇪 Aalst, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium