A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial

Study design: randomized open-label multicenter

Primary endpoint:

'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:

• Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,
• Correct position of the device in the proper anatomical location,
• Intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and
• Only one valve implanted in the proper anatomical location.

Secondary endpoints:

• 30-day-combined safety endpoint which is a combined endpoint defined by VARC as:

• All cause mortality,
• Major stroke,
• Life threatening (or disabling) bleeding,
• Acute kidney injury-Stage 3 (including renal replacement therapy),
• Periprocedural myocardial infarction,
• Major vascular complications and
• Repeat procedure for valve-related dysfunction (surgical or interventional therapy). *
• Combined efficacy endpoint at 1 year which is a composite endpoint defined by VARC as:

• All cause mortality between 30 days and one year,
• Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and
• Prosthetic heart valve dysfunction (aortic valve area < 1.2 cm2 and mean aortic valve gradient > 20 mmHg or peak velocity > 3 m/s or moderate or severe prosthetic valve AR). *
• Cardiovascular mortality as defined by VARC at 1 month, 6 and 12 months. *
• Major adverse cardiovascular and cerebrovascular events (MACCE): myocardial infarction, cardiac or vascular surgery and stroke at 30 days, 6 & 12 months.
• Rehospitalization for heart failure at 12 months
• Quality of life (assessed with the Euro5Qual-questionnaire) at 12 months
• NYHA-class improvement at 30 days, 6 and 12 months
• Vascular complication as defined by VARC at 30 days.
• Post-procedural pacemaker implantation at 1 month
• Major or minor Bleeding at 30 days as defined be VARC.

Inclusion criteria

• Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
• Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
• Age > 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
• Native aortic valve annulus measuring 20-25 mm
• Patients must be suitable for a transfemoral vascular access
• The patient signing a written informed consent prior to intervention

Exclusion criteria

• Life expectancy < 12 months due to co-morbid conditions
• Native aortic valve annulus < 20 mm and > 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
• Pre-existing aortic bioprosthesis
• Cardiogenic shock or hemodynamic instability
• History of, or active endocarditis
• Contraindications for a transfemoral access
• Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
• Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
• Active infection requiring antibiotic treatment
• An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment
• Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period