Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation (NOTION-3)

Thomas Engstrom

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Aortic Valve Stenosis; PCI; TAVI

Treatments: Procedure: PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT03058627

H-16039929

Details and patient eligibility

About

The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.

Enrollment: 454 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter

Exclusion criteria

1. Life expectancy < 1 year due to other severe non-cardiac disease
2. Severe renal failure with estimated glomerular filtration rate < 20 ml/min
3. No PCI-eligible coronary artery stenosis, but rotablation is allowed
4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
6. Only stenoses with thrombolysis in myocardial infarction grad < 3
7. Potential pregnancy
8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
9. More than one chronic total occlusion (CTO)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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454 participants in 2 patient groups

TAVI only

No Intervention group

Description:

TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.

TAVI + FFR-guided complete revascularization

Experimental group

Description:

TAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis \> 90% or FFR ≤ 0.80 in vessels ≥ 2.5 mm in diameter .

Treatment:

Procedure: PCI