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PARTNER TRIAL |
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| Problem | High-risk AS |
| Format | Double-blinded multi-center RCT |
| Treatment | TAVI or surgical AVR |
| Control | Standard therapy (in those unsuitable for surgery) |
| Population | 699 high-risk patients |
| Inclusion criteria | Must be: 1) Severe aortic stenosis -Defined as aortic-valve area of less than 0.8 cm2 plus either a mean valve gradient of at least 40 mm Hg or a peak velocity of at least 4.0 m per second 2) NYHA II+ 3) High risk - deemed to be at high risk for operative complications or death on the basis of coexisting conditions that were associated with a risk of death of at least 15% by 30 days after the procedure. The final determination of high operative risk was made by surgeons at each study center, but we used as a guideline a score of at least 10% on the risk model developed by the Society for Thoracic Surgeons, which uses an algorithm that is based on the presence of coexisting illnesses in order to estimate the 30-day operative mortality. Less than 5% of patients in the population from which the algorithm was derived had a predicted operative risk (risk score) of more than 10%. Two groups: 1) Those suitable for surgical repair -Randomised for TAVI vs. surgery 2) Those unsuitable for surgical repair -Randomised for TAVI vs. standard therapy (often included balloon aortic valvuloplasty) |
| Exclusion criteria | Bicuspid or noncalcified valve Coronary artery disease requiring revascularization Left ventricular ejection fraction of less than 20% Aortic annulus diameter of less than 18 mm or more than 25 mm Ssevere (4+) mitral or aortic regurgitation Recent neurologic event Severe renal insufficiency |
| Follow-up | 2 years |
| Primary endpoint | Rate of death from any cause |
| Secondary endpoint(s) | Death from cardiovascular causes NYHA functional class Repeat hospitalization because of valve- or procedure-related clinical deterioration Myocardial infarction Stroke Acute kidney injury Vascular complications Bleeding 6-minute walk distance Valve performance (as assessed on echocardiography) |
| Details | Crossover between the two study groups was not permitted |
| Brief summary: | TAVI vs. surgery similar mortality, symptoms, stroke. Decrease mortality and symptoms in those not suitable for surgery. |
| PAPER: Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients | |
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| Date | 9 Oct 2010 |
| Journal | N Engl J Med. 2011 Jun 9;364(23):2187-98. |
| Information | TAVR vs. surgery in high risk patients -At 30 days --Reduced all cause death (3.4% vs. 6.5%; p=0.007) --Increased major vascular complications (11.0% vs 3.2%; p<0.001) --Similar stroke risk --Significantly improved symptoms -At 1 year --Similar all cause death (24.2% vs. 26.8%; p=0.44; p=0.001 for non-inferiority) --Similar/increased stroke risk (5.1% vs. 2.4%; p=0.07) --No significant difference in symptoms --Decreased major bleeding and new AF |
| PAPER: Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement | |
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| Date | 3 May 2012 |
| Journal | N Engl J Med. 2012 Mar 26. [Epub ahead of print] |
| Information | TAVR vs. surgery in high risk patients -At 2 years --Similar rates of death of any cause (33.9% vs. 35.0%; p=0.78) --Similar rates of stroke (p=0.52) --Increased rate of paravalvular regurgitation (p<0.001) - itself assoc. with increased late mortality (p<0.001) |
| PAPER: Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery | |
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| Date | 21 Oct 2010 |
| Journal | N Engl J Med. 2010 Oct 21;363(17):1597-607. |
| Information | TAVI vs. standard therapy in patients unsuitable for surgery N.B. Standard therapy includes balloon aortic valvuloplasty -At 1 year --Decreased all cause mortality (30.7% vs. 50.7%; p<0.001) --Decreased composite of death from any cause or repeat hospitalization (42.5% vs. 71.6%; p<0.001) --Decreased NYHA III/IV in survivors (25.2% vs. 58.0%; p<0.001) N.B. -At 30d --Increased risk of stroke (5.0% vs. 1.1%; p=0.06) --Increased risk of major vascular complications (16.2% vs. 1.1%; p<0.001) |
| PAPER: Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis | |
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| Date | 3 May 2012 |
| Journal | N Engl J Med. 2012 Mar 26. [Epub ahead of print] |
| Information | TAVI vs. standard therapy in patients unsuitable for surgery N.B. Standard therapy includes balloon aortic valvuloplasty -At 2 years --Decreased all cause death (43.3% vs. 68.0%; p<0.001) --Decreased admissions (35.0% vs. 72.5%; p<0.001) --Improved functional status (p<0.001) --Increased risk of stroke (13.8% vs. 5.5%, P=0.01; due to ischaemia before 30d, haemorrhage thereafter) |