Clinical trial NCT04385459: Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
Official title: Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Coronary Artery Disease
Keywords: Aortic valve stenosis
Coronary artery disease
Transcatheter aortic valve implantation
Mortality
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2020-05-13
Enrollment: 346
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that underwent a TAVI procedure at Örebro University Hospital between the time period 2009 till 1st december 2019 were included.

Brief summary: Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.

Detailed description: A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.

Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.

Eligibility criteria: Inclusion Criteria:

* All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.

Exclusion Criteria:

* Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.

Primary outcomes:
measure: Mortality
timeFrame: Five years.
Secondary outcomes:
measure: Factors associated with less favorable early and late mortality
timeFrame: Five years
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital
Study officials:
affiliation: Department of Cardiothoracic and Vascular Surgery, Örebro University
name: Ninos Samano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: