Preprocedural assessment of coronary artery disease in patients undergoing transcatheter aortic valve implantation: Rationale and design of the EASE‐IT CT registry

Author:

Mascherbauer Julia1,Rudolph Tanja2,Strauch Justus T.3,Seiffert Moritz3,Bleiziffer Sabine4,Bartko Philipp Emanuel5,Zielinski Marie6,Vijayan Anjaly6,Bramlage Peter6ORCID,Hengstenberg Christian5

Affiliation:

1. Department of Internal Medicine 3 University Hospital St. Pölten, Karl Landsteiner University of Health Sciences Krems Austria

2. Heart and Diabetes Center North Rhine‐Westphalia Bad Oeynhausen Germany

3. Department of Cardiology and Angiology BG University Hospital Bergmannsheil Bochum, Ruhr university Bochum Germany

4. Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Centre, North Rhine‐Westphalia University Hospital, Ruhr‐University Bochum Bad Oeynhausen Germany

5. Department of Internal Medicine II, Division of Cardiology Medical University of Vienna Vienna Austria

6. Institute for Pharmacology and Preventive Medicine Cloppenburg Germany

Abstract

AbstractBackgroundInvasive coronary angiography (ICA) is the standard for pre‐procedural assessment of coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI). However, it requires hospitalization and can be associated with complications. Computed tomography angiography (CTA) may be a viable alternative to rule out prognostically relevant CAD.MethodsThe EASE‐IT CT Registry is an investigator‐initiated, prospective, observational, multicentre pilot registry involving patients aged ≥75 years with severe aortic stenosis (AS) intended to implant a transcatheter heart valve (THV) of the SAPIEN family. A total of 150 patients will be recruited from four sites in Germany and Austria. The registry will consist of two prospective cohorts: the investigational CTA‐only cohort and the CTA + ICA control cohort. The CTA‐only cohort will enrol 100 patients in whom significant (≥50%) left main (LM) and/or proximal left anterior descending artery (LAD) stenosis are ruled out on CTA. The CTA + ICA control cohort will enrol 50 patients who have undergone both CTA and ICA before TAVI and in whom ≥50% LM/proximal LAD stenosis has been ruled out by CTA. Three composite endpoints will be assessed at 3 months post‐TAVI: CAD‐specific endpoints, VARC‐3‐defined device success and early safety.ConclusionThe EASE‐IT CT Registry evaluates whether TAVI can be carried out safely without performing ICA if prognostically relevant CAD of the LM/proximal LAD is ruled out with CTA. If so, the omission of ICA would help streamline the pre‐procedural workup of TAVI patients.

Publisher

Wiley

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