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

Recruiting

Phase N/A Results N/A

Trial Description

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 coronory artery bypass grafting (CABG)
Follow-up : 24 months
Visits : 30 days, 12 and 24 months after index PCI or CABG

Conditions

Interventions

  • Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin. Drug
    ARM 1: Kind: Experimental
    Label: Patients with chronic oral anticoagulation and P2Y12 inhibitor
    Description: 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.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

WOEST2 Registry is designed to recruit an unselected cohort of patients with AF and/or a heart valve prosthesis undergoing coronary revascularisation (PCI/CABG) within at least three European countries (Netherlands, Belgium, United Kingdom). The three international cohorts of patients reflect the spectrum of our study population within the geographic catchment regions. At least 15 hospitals of varying size and characteristics will participate in this study.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Primary The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome]. 1 year No

Sponsors