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Coronary Artery Disease Assessment Strategies in TAVI Patients

ConditionsTranscatheter Aortic Valve ReplacementCoronary Artery DiseaseHeart Disease Risk Factors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.

As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear.

The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease

Selected for treatment with transfemoral TAVI.

Written informed consent.

Disqualifiers

Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention

Unprotected left main coronary stenosis >50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT

Left ventricular ejection fraction (LVEF) < 30%

New regional wall motion abnormalities on echocardiography

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risk-based CAD management

    Diagnostic test

    Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.

  • Invasive coronary angiography

    Diagnostic test

    Routine invasive coronary angiography prior to TAVI. PCI recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.

Treatment groups

546 Participants
are divided into 2 treatment groups
Group A: Risk-based management strategy without invasive coronary angiographyExperimental treatment 1 intervention
Group B: Routine invasive coronary angiographyOther 1 intervention

Trial outcomes

Primary outcomes

1

Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization

Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)

Time frame
3 years

Secondary outcomes

1

Patient reported health status

Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)

Time frame
3 months, 1, 3 and 5 years
2

Patient reported health status

Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health)

Time frame
3 months, 1, 3 and 5 years
3

Patient reported health status

EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)

Time frame
3 months, 1, 3 and 5 years
4

Rate of all cause death

Time frame
3 months, 1, 3 and 5 years

Other outcomes

Sponsors and contacts

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Insel Gruppe AG, University Hospital Bern

Lead sponsor

Clinical Trials Unit Bern (CTU)

Collaborator

Schweizerische Herzstiftung

Collaborator

Source ClinicalTrials.gov
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