Valve Heart Disease Clinical Trial
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
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
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
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