Clinical trial NCT03239509: 15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Official title: 15 Years Outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in South Spain. The Andalousian Aortic Valve Multicentric Study (ANDALVALVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Survival, Prosthesis
Valve Heart Disease
Keywords: long-term survival
bioprosthesis
complications
anticoagulation
mechanichal prosthesis
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical prosthesis

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants alive
timeFrame: From date of surgery until the date of death from any cause, assessed up to 17 years
measure: Late postoperative endpoint of 4 MACE complications
timeFrame: From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 17 years
Secondary outcomes:
measure: Total in-Hospital and Intensive Care Unit stay (in days)
timeFrame: From date of surgery to discharge of the unit and Hospital, up to 6 months
measure: Cardiopulmonary bypass time in minutes needed in the surgery
timeFrame: day 1 after surgery
measure: Cross-clamp ischemic heart time in minutes needed in the surgery
timeFrame: day 1 after surgery
measure: Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
timeFrame: rom date of surgery until the date of first documented transfusional requirement assessed up to 17 years
measure: Structural valve deterioration (SVD) in bioprosthesis
timeFrame: From date of surgery until the date of first documented SVD assessed up to 17 years
measure: Cardiovascular cause of rehospitalization
timeFrame: f first documented Cardiovascular cause of rehospitalization assessed up to 17 years
measure: Postsurgery Mean transprosthetic gradients in mmHg
timeFrame: From date of surgery until the date of Hospital Discharge, documented first Mean transprosthetic gradient in mmHg assessed by echocardiography after surgery.
measure: Late Mean transprosthetic gradients in mmHg
timeFrame: From date of surgery until the date of last documented echocardiography assessed up to 17 years
measure: Any prosthetic infective endocarditis
timeFrame: From date of surgery until the date of first documented prosthetic infective endocarditis, assessed up to 17 years
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Málaga
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta Del Mar
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: FIMABIS, HOSPITAL VIRGEN DE LA VICTORIA DE MÁLAGA
name: EMILIANO A RODRIGUEZ-CAULO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Caulo EA, Macias D, Adsuar A, Ferreiro A, Arias-Dachary J, Parody G, Fernandez F, Daroca T, Rodriguez-Mora F, Garrido JM, Munoz-Carvajal I, Barquero JM, Valderrama JF, Melero JM. Biological or mechanical prostheses for isolated aortic valve replacement in patients aged 50-65 years: the ANDALVALVE study. Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1160-1167. doi: 10.1093/ejcts/ezy459.