Aortic valve replacement in high risk patients: conventional surgery compared with catheter-based techniques
| ISRCTN | ISRCTN45792044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45792044 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/04/2009
- Registration date
- 26/05/2009
- Last edited
- 10/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Marjan Jahangiri
Scientific
Scientific
Atkinson Morley Wing
St George's Healthcare NHS Trust
Blackshaw Road
London
SW17 0QT
United Kingdom
| Phone | +44 20 8725 3565 |
|---|---|
| marjan.jahangiri@stgeorges.nhs.uk |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised trial of transcutaneous versus surgical aortic valve replacement |
| Study acronym | TAVI AVR |
| Study hypothesis | 1. To assess efficacy and safety of the trans-catheter aortic valve implantation (TAVI) 2. To compare efficacy and safety of TAVI with surgical AVR (Cohort A) 3. To compare safety and efficacy of TAVI with medical therapy (Cohort B) 4. To keep a registry of all patients undergoing TAVI To propose TAVI, incremental clinical benefits in a well-defined cohort of patients with the use of rigorous clinical trials need to be demonstrated. That is, these new therapy approaches must have substantive clinical value and cannot simply be the fashionable extrapolation of previous catheter-based treatments for coronary artery and other vascular diseases. To date, TAVI has been restricted to patients at high risk or with contraindication for surgery. The main outcome measure reported has been mortality at 30 days and, in some cases, morbidity. We do not know six month outcome in TAVI, as reported in the literature. Furthermore, quality of life and survival measured beyond three months is scarcely reported. With the economic demand of an ageing population on healthcare, there are no economic analysis and cost-effectiveness of TAVI alone or in comparison with surgical AVR. Although there is enormous enthusiasm for TAVI, it must be emphasised that this technology is in its infancy. It is very important that the patients' needs and quality of life are considered and that clinicians are not drawn into doing the procedure simply because it is a novelty. However, one can legitimately raise the question whether TAVI in a morbid, elderly patient cohort should be held to the same high standards as surgical therapies performed in younger and healthier patients. Assuming that a standard for comparison and analysis of results should be whatever therapy a given patient would usually receive, some transcutaneous devices may be best suited for comparison with surgical valve replacements, whereas others may require comparisons with medical therapy. For example, in patients with heart failure and comorbidities, where surgery is totally contraindicated, TAVI should be compared to medical therapy. European and American Heart Association guidelines and NICE recommend that each patient should be considered in a multidisciplinary meeting consisting of an interventional cardiologist, cardiac surgeon and cardiac anaesthetist. To address whether patients would benefit from only medical therapy, a non-interventional cardiologist should also be present. In view of the current status of TAVI, lack of consistency in selection of patients, reporting of outcomes, the European and American guidelines recommend a randomised study as outlined above and also the need to keep an accurate registry. |
| Ethics approval(s) | Wandsworth Research Ethics Committee, St George's University of London, approval pending as of 22/04/2009 |
| Condition | Severe aortic valve stenosis |
| Intervention | Arm 1: Transcutaneous aortic valve implantation (n = 219) Arm 2: Aortic valve replacement (n = 219) Arm 3: Best medical therapy (n = 219) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Death within the first year |
| Secondary outcome measures | The following will be assessed at 1, 3, 6 and 12 months for the first year, then 6-monthly until the end of 3rd year: 1. Evidence of prosthetic valve dysfunction 2. Postoperative bleeding 3. Freedom from major adverse cardiac and cerebrovascular complications 4. Heart block and need for pacemaker implantation 5. Conversion from TAVI, emergency valve surgery 6. Length of hospital stay and discharge to rehabilitation centre or home 7. Length of hospital stay 8. Improved quality of life, assessee by SF-36® Health Survey and Six-Minute Walk test |
| Overall study start date | 01/09/2009 |
| Overall study end date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 657 |
| Participant inclusion criteria | 1. After a multidisciplinary meeting, patients (both males ane females) with expected mortality >15% (Euroscore) and/or >10% (Society of Thoracic Surgeons Mortality Risk [STS] score) 2. Severe aortic stenosis, confirmed by trans-thoracic echocardiography using a combination of measurements of valve area and flow dependent indices (mean gradient >50 mmHg). Low dose dobutamine echocardiography is useful to differentiate between severe and the rare 'pseudo-severe' aortic stenosis in patients with low left ventricular ejection fraction and low gradient. 3. Severe aortic stenosis, +/- one vessel coronary artery disease amenable to percutaneous intervention 4. Age >70 (if age <70, need to have other significant comorbidities) 5. Symptomatic patients with New York Heart Association (NYHA) grade >II 6. Patients who are able to give consent 7. If it is thought that risks of mortality and morbidity with surgery outweigh the benefits, the patients will be randomised into cohort B |
| Participant exclusion criteria | 1. Aortic regurgitation 2. Patient preference - TAVI is not recommended for patients who simply refuse surgery on the basis of personal preference 3. Aortic annulus <18 or >25 mm for balloon expandable and <20 or >27 mm for self-expandable devices 4. Bicuspid aortic valve 5. Present of asymmetric heavy valvular calcification 6. Aortic root dimensions >4.5 cms 7. Presence of apical left ventricular thrombus 8. Evidence of acute myocardial infarction <30 days 9. Hypertrophic cardiomyopathy 10. Life expectancy <1 year due to non-cardiac causes Specific contraindications for transfemoral approach: 1. Iliac arteries with severe calcification tortuousity and small diameter (6-9 mm), previous aorto-femoral bypass 2. Severe angulation of aorta and atheroma of the outcome and coaptation, aneurysm of the abdominal aorta with mural thrombus 3. Presence of bulky atherosclerosis of the ascending aorta and arch Specific contraindications for the transapical approach: 1. Previous surgery of the left ventricle using a patch such as the Dor procedure 2. Calcified pericardium 3. Severe respiratory insufficiency |
| Recruitment start date | 01/09/2009 |
| Recruitment end date | 31/08/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St George's Healthcare NHS Trust
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
St George's Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Blackshaw Road
Tooting
London
SW17 0QT
England
United Kingdom
| Website | http://www.stgeorges.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/039zedc16 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - decision pending as of 22/04/2009.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
10/08/2017: No publications found in PubMed, verifying study status with principal investigator.
