Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

N/AActive Not RecruitingNCT03058627

Thomas Engstrom454 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

454

Conditions

Coronary Artery Disease Aortic Valve Stenosis TAVI PCI

Interventions

PCIPROCEDURE

FFR guided PCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (12)

Aalborg University Hospital

Aalborg, Denmark

Department of Cardiology, Skejby University Hospital

Aarhus, Denmark

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

All-cause mortality, myocardial infarction, or urgent revascularization

Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Secondary Outcomes

All cause mortality

Number of patients experiencing all cause mortality

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Myocardial infarction

Number of patients experiencing myocardial infarction

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Urgent revascularization

Number of patients experiencing urgent revascularization

Time frame: 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

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Cardiovascular mortality

Number of patients experiencing cardiovascular mortality

Time frame: 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

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Data from ClinicalTrials.gov

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Department of Cardiology, Odense University Hospital

Helsinki University Hospital

Helsinki, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Riga University Hospital

Riga, Latvia

Sahlgrenska

Gothenburg, Sweden

...and 2 more locations

Cardiovascular mortality or myocardial infarction

Number of patients experiencing cardiovascular mortality or myocardial infarction

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Any revascularization

Number of patients experiencing any revascularization

Time frame: 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)

Time frame: 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

Time frame: 30 days and 1 year

Bleeding

Number of patients experiencing bleeding

Time frame: 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

Time frame: 30 days and 1 year

Acute kidney injury

Number of patients experiencing acute kidney injury

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Target vessel revascularization

Number of patients experiencing target vessel revascularization

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Target lession revascularization

Number of patients experiencing target lession revascularization

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Cost effectiveness analysis

Time frame: Until the last included patients have been followed for 1 year after the TAVI

Stent thrombosis

Number of patients experiencing stent thrombosis

Time frame: Until the last included patients have been followed for 1 year after the TAVI