Clinical trial NCT03058627: Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
Official title: Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Aortic Valve Stenosis
TAVI
PCI
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Odense University Hospital
name: Lund University Hospital
name: Karolinska University Hospital
name: Haukeland University Hospital
name: Helsinki University Central Hospital
name: Tampere University Hospital
name: Oulu University Hospital
name: Turku University Hospital
name: Sahlgrenska University Hospital
name: Pauls Stradins Clinical University Hospital
First posted: 2017-02-23
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: All-cause mortality, myocardial infarction, or urgent revascularization
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
Secondary outcomes:
measure: All cause mortality
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Myocardial infarction
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Urgent revascularization
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: All cause mortality or myocardial infarction
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Cardiovascular mortality
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Cardiovascular mortality, myocardial infarction, or urgent PCI
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Cardiovascular mortality or myocardial infarction
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Admission for new onset of heart failure
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Peri-procedural (PCI) myocardial infarction
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Peri-procedural (TAVI) myocardial infarction
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Any revascularization
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Stroke or transient ischemic attack (TIA)
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Angina status (Seattle questionnaire), CCS and NYHA class
timeFrame: 30 days and 1 year
measure: Bleeding
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Quality of Life
timeFrame: 30 days and 1 year
measure: Acute kidney injury
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Target vessel revascularization
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Target lession revascularization
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Cost effectiveness analysis
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
measure: Stent thrombosis
timeFrame: Until the last included patients have been followed for 1 year after the TAVI
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Cardiology, Skejby University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Riga
country: Latvia
facility: Riga University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska
Study officials:
affiliation: Rigshospitalet University Hospital, Denmark
name: Thomas Engstrøm, MD, DMSC, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet University Hospital, Denmark
name: Jacob Lønborg, MD, DMSC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet University Hospital, Denmark
name: Lars Søndergaard, MD, DMSc, PhD
role: STUDY_CHAIR
References: