TAVI and PCI in Comparison to SAVR and CABG in Low and Intermediate Risk Patients With Severe Aortic Stenosis

Brief summary (registry, in English)

# 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.

What you commit to

• Study type: Observational
• Planned participants: 100
• From 1 Feb 2026 to the primary completion date, May 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis and significant coronary artery disease who have low or intermediate surgical risk. It compares valve replacement through a catheter plus stenting with open-heart surgery.

Age

Adults (no exact ages given in the record).

Sex

All sexes can join.

Disease stage

Severe aortic stenosis (valve area 1.0 cm2 or less and/or mean pressure gradient 40 mmHg or more) with at least one of: breathlessness, chest pain, fainting, or other high-risk signs. Also coronary artery narrowing that needs treatment. Low or intermediate surgical risk (STS score 8% or less).

Earlier treatment

No previous coronary artery bypass surgery.

Biomarker or test result

Coronary narrowing of at least 50 for the left main artery and at least 70 for other arteries, or a significant narrowing shown by a pressure test (FFR below 0.80) in an artery 2.5 mm or wider.

Main reasons for not taking part

• Previous coronary artery bypass surgery
• Heart pumping function (LVEF) of 40 or less
• Heart attack within the last 6 months
• Emergency valve procedure or open-heart surgery planned for another reason
• Illness limiting life expectancy to less than 1 year

Read by machine on 10 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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