Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

NCT04385459 — Completed, 346 participants, Örebro County Council

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease

Registry	NCT04385459
Status	Completed
Study type	Observational
Enrollment	346 (Actual)
Sponsor	Örebro County Council (Other gov)
Conditions	Aortic Valve Stenosis, Coronary Artery Disease
Interventions	Coronary artery disease (Other)
Dates	start 2018-12-13, primary completion 2020-12-24, completion 2020-12-24, first posted 2020-05-13, last updated 2021-09-09
Locations	1 site in Sweden

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Patients without coronary artery disease			No prior coronary intervention and no significant stenosis noted during coronary angiography.
Patients with coronary artery disease		Other: Coronary artery disease	Our definition of coronary artery disease is: * Prior coronary artery bypass grafting or percutaneous coronary intervention * Significant stenosis or occlusion noted during coronary angiography

Coronary artery disease (Other): Exposure

+Outcome measures

Primary outcomes

Mortality [Five years.]: Death after the procedure

Secondary outcomes

Factors associated with less favorable early and late mortality [Five years]: Factors such as renal function or comorbidities associated with higher mortality.

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital	Örebro	Sweden

+Investigators

Ninos Samano, MD,PhD, Principal investigator, Department of Cardiothoracic and Vascular Surgery, Örebro University