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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis
• Intervention / Treatment: Other: Coronary artery disease

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.

• Study Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients without coronary artery disease; No prior coronary intervention and no significant stenosis noted during coronary angiography.
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	Other: Coronary artery disease; Exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death after the procedure	Five years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with less favorable early and late mortality	Factors such as renal function or comorbidities associated with higher mortality.	Five years

Collaborators and Investigators

• Sponsor: Örebro County Council
• Investigators: Principal Investigator: Ninos Samano, MD,PhD, Department of Cardiothoracic and Vascular Surgery, Örebro University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2018
• Primary Completion (ACTUAL): December 24, 2020
• Study Completion (ACTUAL): December 24, 2020

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (ACTUAL): May 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease; Mortality; Aortic valve stenosis; Transcatheter aortic valve implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 273468

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No