Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 6
- Primary Endpoint
- Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Investigational CTA-only 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
- •CTA+ICA control Cohort
- •Consecutive adult patients ≥ 75 years
- •Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis
- •Ability to undergo CTA and ICA
Exclusion Criteria
- •investigational CTA-only Cohort
- •Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50%
- •Any prior coronary revascularization / prior aortic valve replacement
- •Life expectancy below 12 months
- •Lack of informed consent / data protection statement
- •CTA+ICA control Cohort
- •Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline
- •Any prior coronary revascularization / prior aortic valve replacement
- •Life expectancy below 12 months
- •Lack of informed consent / data protection statement
Outcomes
Primary Outcomes
Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI
Time Frame: 30 days
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
Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI
Time Frame: 3 months
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.
Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria
Time Frame: 30 days
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.
Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria
Time Frame: 30 days
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.
Secondary Outcomes
No secondary outcomes reported