Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

St. Antonius Hospital1,016 enrolled

Overview

At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk. We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).

The trial consists of two cohorts: * Cohort A, patients without an indication for OAC prior to TAVI. * Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,016

Conditions

Aortic Valve Disease Myocardial Infarction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cohort A 1\. Patient has provided written informed consent. * Cohort B 1. Need for long-term oral anticoagulation; 2. Patient has provided written informed consent. Exclusion Criteria: * Cohort A 1. Need for long-term oral anticoagulation; 2. Drug-eluting stent implantation within 3 months prior to TAVI procedure; 3. Bare-metal stent implantation within 1 month prior to TAVI procedure; 4. Allergy or intolerance to aspirin or clopidogrel. * Cohort B 1. Drug-eluting stent implantation within 3 months prior to TAVI procedure; 2. Bare-metal stent implantation within 1 month prior to TAVI procedure; 3. Allergy or intolerance to (N)OAC or clopidogrel.

Locations (17)

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium

Onze Lieve Vrouwe Ziekenhuis

Aalst, Belgium

Imelda Ziekenhuis

Bonheiden, Belgium

Algemeen Ziekenhuis Sint Jan

Bruges, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Charles university, Third Faculty of Medicine

Prague, Czechia

National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle

Luxembourg, Luxembourg

Academic Medical Centre (AMC)

Amsterdam, North Holland, Netherlands

Isala Clinics

Zwolle, Overijssel, Netherlands

...and 7 more locations

Outcomes

Primary Outcomes

Safety endpoint

The primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI. The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI. For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC).

Time frame: 1 year

Secondary Outcomes

Net-clinical benefit endpoint

The secondary outcome is a net-clinical benefit endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, non-procedure related bleeding, stroke, or myocardial infarction at 1 year after TAVI.

Time frame: 1 year

Efficacy endpoint

The co-secondary outcome is an efficacy endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, ischemic stroke, or myocardial infarction at 1 year after TAVI.

Time frame: 1 year

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

Overview

Conditions

Interventions

Eligibility

Locations (17)

Outcomes

Primary Outcomes

Secondary Outcomes