The EASE-IT CT Registry

Study Overview
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Brief Summary
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ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

Detailed Description
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Patients undergoing TAVI require routine pre-procedural assessment of CAD (coronary artery disease). ICA (invasive coronary angiography) is the gold standard in patients with high pre-test probability. It is associated, however, with procedural risk, radiation and cost. CTA (computed tomography angiography) currently has limited use for the evaluation of CAD in pts with severe symptomatic AS (aortic stenosis) - medications required such as beta blockers and nitroglycerine, are frequently not well tolerated by pts. But as TAVI is increasingly being performed in patients with modest pre-test probabilities for obstructive CAD or a lack of implications thereof (pts. ≥75 yrs), the use of CTA may become more appealing.

Official Title
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Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA

Conditions
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Transcatheter Aortic Valve Implantation (TAVI)

Intervention / Treatment
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* Other: Streamlining of the pre-procedural patient pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prospective Cohort Consecutive adult patients ≥ 75 years Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family Ability to undergo CTA Patient is scheduled to undergo a 30 Day and 3 Months follow-up Retrospective Cohort Consecutive adult patients ≥ 75 years Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis Patients underwent both CTA and ICA before the procedure Patient underwent a 30 Day and 3 Months follow-up Exclusion Criteria: Prospective Cohort Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Valve in valve intervention (ViV) Life expectancy below 12 months Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC) Retrospective Cohort Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Valve in valve intervention (ViV) Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort<br>100 consecutive patients that are not already diagnosed with severe (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM). | Other: Streamlining of the pre-procedural patient pathway<br>* Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety.<br>|
| Retrospective cohort<br>50 consecutive patients from the participating centers that already underwent CTA and ICA prior to TAVI will serve as a historical control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI | CAD specific combined endpoint at 30 days All-cause death Non-fatal myocardial infarction Ischemia-driven revascularization Rehospitalization (valve- or procedure-related including heart failure) Life-threatening/disabling or major bleeding Number and percentage of subjects with above specified outcomes at 30 days | 30 days | 
| Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI | CAD specific combined endpoint at 3 months All-cause death Non-fatal myocardial infarction Ischemia-driven revascularization Rehospitalization (valve- or procedure-related including heart failure) Life-threatening/disabling or major bleeding Number and percentage of subjects with above specified outcomes at 3 months. | 3 months | 
| Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria | VARC-3 defined device success at 30 days: Technical success Freedom from mortality Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) Number and percentage of subjects with device success at 30 days as per VARC-3 definition. | 30 days | 
| Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria | VARC-3 defined early safety at 30 days: Freedom from all-cause mortality Freedom from all Stroke Freedom from all VARC type 2-4 bleeding Freedom from all major vascular, access-related, or cardiac structural complication Freedom from all acute kidney injury stage III/IV Freedom from all moderate/severe aortic regurgitation Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities Freedom from all surgery/intervention related to the device Number and percentage of subjects free from VARC3-defined safety issues at 30 days as per VARC-3 definition. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive coronary angiography, Coronary Artery Disease, CAD, TAVI, Transcatheter Aortic Valve Implantation, severe Aortic Stenosis, sAS, computed tomography angiography, CTA, ICA