Compares catheter and surgical treatment for narrowed aortic valve and blocked heart arteries

Trial details

Who runs it

Alexandria University

Trial code

NCT07926022

Record updated

9 November 2026

Original description

# WHAT IS THIS STUDY ABOUT?Read full original descriptionShow less

Transcatheter Aortic Valve Implantation Combined With Percutaneous Coronary Intervention in Comparison to Surgical Aortic Valve Replacement Combined With Coronary Artery Bypass Grafting in Low and Intermediate Surgical Risk Patients With Severe Aortic Stenosis and Significant Coronary Artery Disease

# WHAT IS THIS STUDY ABOUT?

This study compares two different treatment approaches for patients with two heart conditions occurring simultaneously: a narrowed heart valve (aortic stenosis) and narrowed or blocked heart arteries (coronary artery disease). Both conditions are serious and, when they occur together, place considerable strain on the heart. The heart must work harder to pump blood through the narrowed valve while simultaneously receiving an inadequate blood supply through the blocked coronary arteries.

# WHY IS THIS STUDY NEEDED?

Until recently, the main treatment option for patients with both conditions was open-heart surgery. This major operation involves opening the chest, temporarily stopping the heart, replacing the heart valve with an artificial valve, and performing coronary artery bypass grafting to restore blood flow around the blocked arteries. Although effective, combined surgery carries significant risks, particularly in older or frailer patients, including prolonged recovery, longer hospital stays (often 2 to 3 weeks), bleeding, kidney injury, and other complications.

A newer, less invasive treatment approach is now available. This involves replacing the heart valve through a thin tube (catheter) inserted through a blood vessel in the groin, without opening the chest, and treating the blocked coronary arteries using a fine wire, a small balloon, and a metal mesh tube (stent) placed inside the artery. This approach, known as transcatheter aortic valve implantation (TAVI) combined with percutaneous coronary intervention (PCI), typically requires a shorter hospital stay of approximately 2 to 4 days and may allow an earlier return to normal activities.

However, sufficient evidence from well-designed studies is not yet available to establish whether this less invasive approach is as safe and effective as conventional surgery in patients who are not considered at high surgical risk.

This study aims to address this evidence gap.

# WHO CAN JOIN THIS STUDY?

Adults with severe aortic stenosis and significant coronary artery disease who have been assessed by a specialist heart team as having low or intermediate surgical risk may be eligible to participate.

All participants must be considered suitable for both the catheter-based treatment approach and the surgical approach, based on individual coronary anatomy, clinical characteristics, and medical history.

Patients with previous coronary artery bypass graft surgery, severely impaired left ventricular systolic function (ejection fraction below 40%), or a recent myocardial infarction within the previous 6 months are not eligible to participate.

* WHAT WILL HAPPEN IF A PATIENT JOINS THE STUDY?

Participants will receive one of two treatment approaches, selected by a specialist heart team according to individual coronary and valvular anatomy, clinical circumstances, and patient preference:

1. Catheter-based aortic valve replacement combined with coronary artery stenting (TAVI + PCI). 2. Conventional open-heart surgery involving surgical aortic valve replacement and coronary artery bypass grafting (SAVR + CABG).

Regardless of the treatment received, all participants will undergo follow-up assessments at hospital discharge, 30 days, 6 months, and 1 year after the procedure. Follow-up will include clinical assessments and appropriate cardiac investigations. * WHAT IS THE STUDY MEASURING?

The study will evaluate the incidence of major complications, including all-cause mortality, myocardial infarction, stroke, serious bleeding, and the need for urgent repeat intervention, during the index hospitalization and within 1 year after the procedure.

Additional outcomes will include recovery duration, length of hospital stay, and changes in kidney function. * WHERE IS THE STUDY TAKING PLACE?

The study is being conducted at Alexandria University Hospitals and other major cardiac centres across Egypt, with a planned total enrolment of 100 participants.

# WHO IS CONDUCTING THE STUDY?

The study is being conducted by Dr. Moustafa AbdelMohsen Elsayed Madkour, Department of Cardiology and Angiology, Faculty of Medicine, Alexandria University, Egypt, under the supervision of Prof. Dr. Mohamed Ahmed Sobhy and Prof. Dr. Tarek Hussien Elzawawy.

Inclusion: Patients with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI by a multidisciplinary Heart Team; Severe aortic stenosis defined as AVA ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria:; Dyspnea. B. Angina. C. Syncope. D. Decline in left ventricular ejection fraction <50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity >5.5 m/s, severe valve calcification or peak transaortic velocity progression ≥0.3 m/s per year, ) according to current guidelines.(1); Coronary revascularization indicated in angiographically critical stenosis defined as ≥50 for LM and ≥ 70 otherwise, or functionally significant stenosis (fractional flow reserve (FFR) value <0.80) in a coronary artery ≥2.5 mm in diameter and TIMI flow grade III.(12); Classified as low or intermediate surgical risk (STS score ≤8%); Deemed eligible for both TAVI and SAVR by the Heart Team; Able and willing to provide informed consent and comply with study protocol.

Exclusion: Previous coronary artery bypass grafting (CABG); Contraindications to dual antiplatelet therapy or anticoagulation; Acute myocardial infarction within 6 months of planned procedure; Planned open-heart surgery for another indication; Severe comorbid conditions limiting life expectancy to <1 year; Left ventricular ejection fraction (LVEF) ≤40; Emergent or salvage valve intervention; Inability to comply with follow-up or provide informed consent.

ClinicalTrials.gov NCT07926022