Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial

Phase 4

Completed

• Conditions: Aortic Valve Disease; Myocardial Infarction; Stroke
• Interventions: Drug: Aspirin (80 mg/d) + clopidogrel (75 mg/d); Drug: Aspirin

• Registration Number: NCT01559298
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Brief Summary

The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the prevention of major ischemic events \[myocardial infarction (MI), ischemic stroke\] or death without increasing the risk of major bleeding events.

Detailed Description

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to standard aortic valve replacement for the treatment of patients considered to be at very high or prohibitive surgical risk. Nowadays the procedure is associated with a very high success rate (\> 95%) but major peri-procedural ischemic complications such as myocardial infarction (MI) or ischemic stroke occur in about 2% (0% to 17%) and 3% (2% to 7%) of the cases, respectively. The recently published PARTNER trial showed a stroke rate as high as 6.5% within the 30 days following TAVI, with most (77%) of these events diagnosed as major strokes. In order to avoid such ischemic complications full dose anticoagulation (usually intravenous heparin) is administered during the TAVI procedure, whereas aspirin (long-term) + clopidogrel (1 to 6 months) have been the recommended antithrombotic treatment following the procedure. However, this antithrombotic regime has been recommended on an empirical basis, and no studies have as yet shown the efficacy of aspirin + clopidogrel versus aspirin alone or no antithrombotic treatment in preventing ischemic events following TAVI procedures. Also, patients undergoing TAVI nowadays are usually octogenarians and very frequently exhibit comorbidities such as hypertension, abnormal renal function or prior cerebrovascular disease, which significantly increase the risk of major bleeding. Indeed, TAVI procedures can also be associated with major vascular complications which in turn can complicate with life-threatening or major bleeding. It is well know that clopidogrel on top of aspirin is associated with a higher rate of major bleeding complications, especially in elderly patients. It would therefore be of major clinical relevance to determine the risk/benefit ratio of using a dual antithrombotic therapy following TAVI procedures in order to recommend the most appropriate antithrombotic treatment in this high-risk population. The ARTE trial is a multicenter Canadian pilot trial to evaluate the efficacy and safety of aspirin versus aspirin + clopidogrel as antithrombotic treatment after TAVI.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2015-03
• Study Completion: 2016-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Patients undergoing a TAVI procedure with the Edwards SAPIEN XT valve (transfemoral or transapical)

Exclusion Criteria

• Need for chronic anticoagulation treatment
• Major bleeding within the 3 months prior to the TAVI procedure
• Prior intracranial bleeding
• Drug-eluting stent implantation within the year prior to the TAVI procedure
• Allergy to clopidogrel and/or aspirin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin + clopidogrel	Aspirin (80 mg/d) + clopidogrel (75 mg/d)	Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d) + clopidogrel (75 mg/d) following the TAVI procedure.
Aspirin	Aspirin	Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d)

Primary Outcome Measures

Name	Time	Method
Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding	12-month follow-up

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	At 30 days and at 12-month follow-up
Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding	30 days
Incidence of MI or ischemic stroke	At 30 days and at 12-month follow-up
Cost-effectiveness of clopidogrel on top of aspirin following TAVI	At 30 days and at 12-month follow-up
Incidence of major bleeding	At 30 days and at 12-month follow-up
Rate of minor bleeding	At 30 days and at 12-month follow-up

Trial Locations

Locations (2)

St-Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

IUCPQ; 🇨🇦 Quebec, Canada