SPAnish Aortic VALVE Multicentric Study

Valve Heart Disease Clinical Trial

— SPAVALVE  

Official title:

Retrospective Multicentric Study Spanish SPALVALVE: Follow-up to 15 Years of Patients Between 50-65 Years Undergoing Isolated Aortic Valve Replacement. Biological or Mechanical Prostheses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03595423
• Other study ID #: SPAVALVE
• Status: Recruiting
• Start date: July 10, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2018
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: EMILIANO A RODRIGUEZ CAULO, MD, PhD,FECTS
• Phone: +34951032054
• Email: erodriguezcaulo[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 30 Cardiovascular Surgery Centers in Spain

Description:

Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (early 30-day death, 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,, 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 30 centers with a Cardiovascular Surgery Dept. in SPAIN as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and infective endocarditis.

Survival analysis and clinical data records will be performed through the Public Health Care computed medical records , and direct telephone contact with family and / or relatives, in case of doubts. A crude analysis of the data and a posterior analysis by propensity score matching with SPSS or R software will be carried out using a 1: 1 or 2:1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 5000 cases is expected, of which about 1000 would be bioprostheses that would serve as a basis for the pairing. According to previous data(ANDALVALVE STUDY), to find a 4.8% difference in the primary endpoint, two groups of 1025 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Subanalysis will be performed by subgroups of age (50-55 vs. 55-65 years) and another according to the mark of the 2 prostheses of each type most implanted. 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 or Private biostatistics. Competing risks analysis will be performed to calculate the cumulative incidence of stroke, reoperation and major bleeding for each prosthesis type.

Conclusions: A positive result (similar survival in group B, with lower complications) could change the current indications of AVR in our environment, allowing the age of indication for bioprostheses in European guidelines to be reduced below 60 years

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Prosthesis Durability
• Prosthesis Failure
• Survival, Prosthesis
• Valve Heart Disease

Intervention

Procedure:
• Surgical AVR with bioprosthetic or mechanical prosthesis
Surgical AVR with bioprosthetic or mechanical prosthesis

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de La Victoria	Malaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants alive	Survival since surgery	From date of surgery until the date of death from any cause, assessed up to 18 years
Primary	Late postoperative combined endpoint of 4 Major Adverse Cardiovascular Events (MACE) complications	Early 30-day Mortality, major bleeding, stroke and need of any prosthesis reoperation	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 18 years
Secondary	Cumulative incidence of stroke at 15 years between groups	stroke cumulative incidence over time (competing risk analysis)	From date of surgery until the date of first documented stroke or date of death from any cause, whichever came first, assessed up to 18 years
Secondary	Cumulative incidence of prosthesis reoperation at 15 years between groups	reoperation cumulative incidence over time (competing risk analysis)	From date of surgery until the date of first documented reoperation or date of death from any cause, whichever came first, assessed up to 18 years
Secondary	Cumulative incidence of major bleeding at 15 years between groups	major bleeding cumulative incidence over time (competing risk analysis)	From date of surgery until the date of first documented major bleeding or date of death from any cause, whichever came first, assessed up to 18 years