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

NCT ID: NCT04385459

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2020-12-24

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.

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients without coronary artery disease

No prior coronary intervention and no significant stenosis noted during coronary angiography.

No interventions assigned to this group

Patients with 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

Intervention Type: OTHER

Exposure

Interventions

Coronary artery disease

Exposure

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Örebro County Council

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ninos Samano M.D.

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ninos Samano, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic and Vascular Surgery, Örebro University

Locations

Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital

Örebro, , Sweden

Countries

Sweden

Other Identifiers

273468

Identifier Type: -

Identifier Source: org_study_id