SurgeryANDALVALVENCT03239509
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
An observational study of Surgery and Survival, Prosthesis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 7 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Surgery, Survival, Prosthesis, Valve Heart Disease
- What is being tested?
- bioprosthesis implantation between 2000-2015 and mechanical prosthesis implantation between 2000-2015
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 7 sitesSpain
- Study dates
- Jan 2017to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive
Who cannot join
- Not reported Residency change (unreachable)
- Need of concomitant surgery
- Reoperations
- Infective endocarditis
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario Puerta Del Mar
Cadiz
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario Virgen de Las Nieves
Granada
Hospital Regional Universitario de Malaga
Málaga, Málaga
Hospital Universitario Virgen de La Victoria
Málaga
Hospital Universitario Virgen Del Rocio
Seville
Hospital Universitario Virgen Macarena
Seville
About this study
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)
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.
Read more
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)
Read the 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.
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Being tested
- bioprosthesis implantation between 2000-2015, mechanical prosthesis implantation between 2000-2015
- Keywords
- long-term survival, bioprosthesis, complications, anticoagulation, mechanichal prosthesis
- Medical subject headings
- Prosthesis Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioprosthesis implantation between 2000-2015Procedure or surgery
Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass
mechanical prosthesis implantation between 2000-2015Procedure or surgery
Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Bioprosthesis | All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive. Receives: Procedure: bioprosthesis implantation between 2000-2015 | |
| Mechanical prosthesis | All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive. Receives: Procedure: mechanical prosthesis implantation between 2000-2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants alive
Survival since surgery
Measured: From date of surgery until the date of death from any cause, assessed up to 17 years
Late postoperative endpoint of 4 MACE complications
All cause Mortality, major bleeding, cerebrovascular or transient ischemic accident, and need of any prosthesis reintervention (Major Adverse Cardiovascular Events, MACE)
Measured: 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 (9)
Total in-Hospital and Intensive Care Unit stay (in days)
Total in-Hospital and Intensive Care Unit stay (in days)
Measured: From date of surgery to discharge of the unit and Hospital, up to 6 months
Cardiopulmonary bypass time in minutes needed in the surgery
Cardiopulmonary bypass time in minutes needed in the surgery
Measured: day 1 after surgery
Cross-clamp ischemic heart time in minutes needed in the surgery
Cross-clamp ischemic heart time in minutes needed in the surgery
Measured: day 1 after surgery
Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
transfusional needs in long term follow up
Measured: rom date of surgery until the date of first documented transfusional requirement assessed up to 17 years
Structural valve deterioration (SVD) in bioprosthesis
increase in 20 mmHg in transaortic gradient since discharge echocardiography, any aortic regurgitation greater than moderate or need for bioprosthesis reoperation
Measured: From date of surgery until the date of first documented SVD assessed up to 17 years
Cardiovascular cause of rehospitalization
any cardiovascular cause which need rehospitalization after surgery
Measured: f first documented Cardiovascular cause of rehospitalization assessed up to 17 years
Postsurgery Mean transprosthetic gradients in mmHg
measured by the first echocardiography after surgery
Measured: From date of surgery until the date of Hospital Discharge, documented first Mean transprosthetic gradient in mmHg assessed by echocardiography after surgery.
Late Mean transprosthetic gradients in mmHg
measured by the last echocardiography in follow up
Measured: From date of surgery until the date of last documented echocardiography assessed up to 17 years
Any prosthetic infective endocarditis
definite diagnosis of early or late infective endocarditis
Measured: From date of surgery until the date of first documented prosthetic infective endocarditis, assessed up to 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study startJan 2017
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIANO A RODRIGUEZ-CAULO, MD, PhD, Principal investigator, FIMABIS, HOSPITAL VIRGEN DE LA VICTORIA DE MÁLAGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239509
- Sponsor's protocol ID
- ANDALVALVE STUDY
- Acronym
- ANDALVALVE
- Status last verified
- Jan 2018
- First submitted
- 12 Jul 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30608571
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03239509
- Acronym / sponsor ID
- ANDALVALVE / ANDALVALVE STUDY
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Keywords
- long-term survival, bioprosthesis, complications, anticoagulation, mechanichal prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioprosthesis | – | Procedure: bioprosthesis implantation between 2000-2015All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive. |
| Mechanical prosthesis | – | Procedure: mechanical prosthesis implantation between 2000-2015All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive
Key exclusion criteria (4 listed)
- Not reported Residency change (unreachable)
- Need of concomitant surgery
- Reoperations
- Infective endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioprosthesis implantation between 2000-2015Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass | Procedure or surgery | Bioprosthesis |
| mechanical prosthesis implantation between 2000-2015Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass | Procedure or surgery | Mechanical prosthesis |
Primary outcome
Number of participants alive
Time frame: From date of surgery until the date of death from any cause, assessed up to 17 years
Survival since surgery
Late postoperative endpoint of 4 MACE complications
Time frame: 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
All cause Mortality, major bleeding, cerebrovascular or transient ischemic accident, and need of any prosthesis reintervention (Major Adverse Cardiovascular Events, MACE)
9 secondary outcomes
Total in-Hospital and Intensive Care Unit stay (in days)
Time frame: From date of surgery to discharge of the unit and Hospital, up to 6 months
Cardiopulmonary bypass time in minutes needed in the surgery
Time frame: day 1 after surgery
Cross-clamp ischemic heart time in minutes needed in the surgery
Time frame: day 1 after surgery
Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
Time frame: rom date of surgery until the date of first documented transfusional requirement assessed up to 17 years
Structural valve deterioration (SVD) in bioprosthesis
Time frame: From date of surgery until the date of first documented SVD assessed up to 17 years
Cardiovascular cause of rehospitalization
Time frame: f first documented Cardiovascular cause of rehospitalization assessed up to 17 years
Postsurgery Mean transprosthetic gradients in mmHg
Time frame: From date of surgery until the date of Hospital Discharge, documented first Mean transprosthetic gradient in mmHg assessed by echocardiography after surgery.
Late Mean transprosthetic gradients in mmHg
Time frame: From date of surgery until the date of last documented echocardiography assessed up to 17 years
Any prosthetic infective endocarditis
Time frame: From date of surgery until the date of first documented prosthetic infective endocarditis, assessed up to 17 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 30608571Rodriguez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIANO A RODRIGUEZ-CAULO, MD, PhD principal investigator
FIMABIS, HOSPITAL VIRGEN DE LA VICTORIA DE MÁLAGA
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Survival, Prosthesis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants alive (time frame: From date of surgery until the date of death from any cause, assessed up to 17 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.