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15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years (ANDALVALVE)

F

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status

Completed

Conditions

Survival, Prosthesis
Valve Heart Disease
Surgery

Treatments

Procedure: bioprosthesis implantation between 2000-2015
Procedure: mechanical prosthesis implantation between 2000-2015

Study type

Observational

Funder types

Other

Identifiers

NCT03239509
ANDALVALVE STUDY

Details and patient eligibility

About

Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).

There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B.

Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era.

The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 5 Cardiovascular Surgery Centers in Andalousia (south Spain)

Full description

Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (death of any cause, neurological events (TIA / stroke), any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives were to analyze the evolution of transprosthetic gradients by echocardiography, type of INR control, and degree of significant structural degeneration in bioprostheses.

Material and Method: A retrospective analytical study of patients aged 50-65 years who underwent AVR surgery for stenosis between 2000-2015 in all centers with a Cardiovascular Surgery Dept. in Andalousia (SPAIN) as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and endocarditis. Survival analysis and clinical data will be performed through the Diraya Health Care medical records (DAE), direct telephone contact with family and / or relatives, A crude analysis of the data and a posterior analysis by propensity score matching with the help of the Foundation for Biomedical Research of Malaga (IBIMA) with SPSS software will be carried out using a 1: 1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 1200 cases is expected, of which about 380 would be bioprostheses that would serve as a basis for the pairing. To find a 10% difference in the primary endpoint, two groups of 325 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Sub-analysis will be performed by subgroups of age (50-59 vs. 60-65 years) and another according to the mark of the 2 prostheses of each type most used. All statistical analyzes will be two-tailed with an alpha error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA biostatistics.

Conclusions: A positive result (similar survival and prosthetic durability in group B, with lower complications) could change the current indications of AVS in our environment, allowing the age of indication of bioprostheses to be reduced below 60 years.

Enrollment

1,200 patients

Sex

All

Ages

50 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive

Exclusion criteria

  • Not reported Residency change (unreachable)
  • Need of concomitant surgery
  • Reoperations
  • Infective endocarditis

Trial design

1,200 participants in 2 patient groups

Bioprosthesis
Description:
All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive.
Treatment:
Procedure: bioprosthesis implantation between 2000-2015
Mechanical prosthesis
Description:
All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive.
Treatment:
Procedure: mechanical prosthesis implantation between 2000-2015

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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