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

Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; PCI; TAVI
• Intervention / Treatment: Procedure: PCI

• Study Type: Interventional
• Enrollment (Actual): 454
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark, 8200
    • Department of Cardiology, Skejby University Hospital
  • Copenhagen, Denmark
    • Rigshospitalet, Copenhagen University Hospital
  • Odense, Denmark, 5000
    • Department of Cardiology, Odense University Hospital
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital
• Latvia
  • Riga, Latvia
    • Riga University Hospital
• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska
  • Lund, Sweden
    • Lund University Hospital
  • Stockholm, Sweden
    • Karolinska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TAVI only; TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
Experimental: TAVI + FFR-guided complete revascularization; 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 .	Procedure: PCI; FFR guided PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality, myocardial infarction, or urgent revascularization	Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI	Until the last included patients have been followed for 1 year after the TAVI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Number of patients experiencing all cause mortality	Until the last included patients have been followed for 1 year after the TAVI
Myocardial infarction	Number of patients experiencing myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI
Urgent revascularization	Number of patients experiencing urgent revascularization	Until the last included patients have been followed for 1 year after the TAVI
All cause mortality or myocardial infarction	Number of patients experiencing all cause mortality or myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality	Number of patients experiencing cardiovascular mortality	Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality, myocardial infarction, or urgent PCI	Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI	Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality or myocardial infarction	Number of patients experiencing cardiovascular mortality or myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI
Admission for new onset of heart failure	Number of patients experiencing admission for new onset of heart failure	Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (PCI) myocardial infarction	Number of patients experiencing peri-procedural (PCI) myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (TAVI) myocardial infarction	Number of patients experiencing peri-procedural (TAVI) myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI
Any revascularization	Number of patients experiencing any revascularization	Until the last included patients have been followed for 1 year after the TAVI
Stroke or transient ischemic attack (TIA)	Number of patients experiencing stroke or transient ischemic attack (TIA)	Until the last included patients have been followed for 1 year after the TAVI
Angina status (Seattle questionnaire), CCS and NYHA class	Number of patients experiencing CCS and NYHA class	30 days and 1 year
Bleeding	Number of patients experiencing bleeding	Until the last included patients have been followed for 1 year after the TAVI
Quality of Life	Number of patients experiencing improvement in Quality of life	30 days and 1 year
Acute kidney injury	Number of patients experiencing acute kidney injury	Until the last included patients have been followed for 1 year after the TAVI
Target vessel revascularization	Number of patients experiencing target vessel revascularization	Until the last included patients have been followed for 1 year after the TAVI
Target lession revascularization	Number of patients experiencing target lession revascularization	Until the last included patients have been followed for 1 year after the TAVI
Cost effectiveness analysis	Cost effectiveness analysis	Until the last included patients have been followed for 1 year after the TAVI
Stent thrombosis	Number of patients experiencing stent thrombosis	Until the last included patients have been followed for 1 year after the TAVI

Collaborators and Investigators

• Sponsor: Thomas Engstrom
• Collaborators: Odense University Hospital; Karolinska University Hospital; Turku University Hospital; Helsinki University Central Hospital; Aarhus University Hospital; Oulu University Hospital; Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; Haukeland University Hospital; Aalborg University Hospital; Tampere University Hospital; Pauls Stradins Clinical University Hospital; Lund University Hospital
• Investigators: Study Chair: Thomas Engstrøm, MD, DMSC, PhD, Rigshospitalet University Hospital, Denmark; Principal Investigator: Jacob Lønborg, MD, DMSC, PhD, Rigshospitalet University Hospital, Denmark; Study Chair: Lars Søndergaard, MD, DMSc, PhD, Rigshospitalet University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis
• Other Study ID Numbers: H-16039929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No