TAVI and PCI vs SAVR and CABG in low- and intermediate-risk patients with severe aortic stenosis and CAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines two treatment approaches for patients with concomitant severe aortic stenosis and coronary artery disease. It compares transfemoral TAVI with PCI to open-heart SAVR with CABG, aiming to understand outcomes in low- and intermediate-risk patients. The study leverages real-world clinical decisions made by a multidisciplinary Heart Team to explore feasibility and safety of less invasive versus traditional surgical strategies. Outcomes likely focus on cardiovascular events, mortality, and complication rates, with attention to the impact of concomitant coronary intervention on valve therapy results. The design acknowledges potential challenges in assessing coronary physiology (e.g., FFR/iFR) in the setting of severe AS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

A. 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 Criteria:

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

Where it's running

• Alexandria University Hospital
  Alexandria, Alexandira, Egypt Recruiting

Study contacts

• Study coordinator: moustafa A.E.M Madkour, masters in cardiology
• Email: moustafa_madkor19@hotmail.com
• Phone: 00201120282930

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.