Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial

Medical University Innsbruck700 enrolled

Overview

The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.

The goal of this randomized, multicenter trial is to assess the safety and efficacy of a non-invasive diagnostic strategy using photon-counting detector computed tomography (PCD-CT) for the assessment of coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR), compared to the current standard of care using invasive coronary angiography (ICA). The trial evaluates the hypothesis that a PCD-CT-guided strategy is non-inferior to routine ICA with respect to the risk of major adverse cardiovascular events (MACE) at 12 months. MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

700

Conditions

Aortic Valve Stenosis and Insufficiency Coronary Artery Disease(CAD)

Interventions

Standard Invasive Coronary AngiographyDIAGNOSTIC_TEST

Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.

PCD-CT-Guided Diagnostic StrategyDIAGNOSTIC_TEST

Participants randomized to this arm will undergo coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT). Invasive coronary angiography (ICA) will only be performed if PCD-CT shows significant CAD, defined as ≥70% diameter stenosis in vessels ≥2.5 mm or ≥50% in the left main artery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines * TAVR candidate * Written informed consent Exclusion Criteria: * Cardiogenic shock at presentation (e.g., emergency indication for TAVR) * Severe renal impairment with an estimated glomerular filtration rate of \<30 mL/min/1.73 m² * Life expectancy \<1 year due to other severe non-cardiac disease (e.g., malignancy) * Pregnancy

Outcomes

Primary Outcomes

Major adverse cardiovascular events (MACE) at 12 months

MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding events. All events will be adjudicated by an independent, blinded clinical events committee.