1 / 22

Partner Trial

Partner Trial. TAVI or not TAVI… Raj Chahal 05/07/2011. NEJM 2011; 364:2187-2198. June 9, 2011 Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

ince
Download Presentation

Partner Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Partner Trial TAVI or not TAVI… Raj Chahal 05/07/2011

  2. NEJM 2011; 364:2187-2198 • June 9, 2011 • Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients • Results for the high-risk subgroup of patients in the PARTNER trial who were still candidates for surgical valve replacement and who were randomly assigned to undergo either transcatheter or surgical replacement of the aortic valve.

  3. Study Purpose • The purpose of this trial is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

  4. Aortic Stenosis • Poor survival of severe aortic valve stenosis after onset of symptoms. • Surgical aortic-valve replacement improves symptoms and survival. • Sub-groups of patients at high risk due to comorbidities, poor LV function, and advanced age.

  5. From May 11, 2007, through August 28, 2009 • Prospective, randomized-controlled, multi-center • 699 patients with severe aortic stenosis and cardiac symptoms (NYHA ≥2) • 22 centers in the United States, 2 centers in Canada, and 1 center in Germany. • Deemed high risk ifrisk of death of at least 15% by 30 days after the procedure.

  6. Inclusion Criteria • 1. Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient >40 mm Hg or jet velocity > 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2). • 2. Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II.

  7. Exclusion Criteria • Bicuspid or noncalcified valve, • Coronary artery disease requiring revascularization, • LVEF of less than 20%, • Aortic annulus diameter of less than 18 mm or more than 25 mm, • Severe (4+) mitral or aortic regurgitation, • Recent neurologic event, • Severe renal insufficiency.

  8. Device • Edwards Lifesciences • SAPIEN heart-valve system • Either transfemoral or transapical approach • Depending if peripheral arteries can accommodate 22F or 24F

  9. Study EndpointsPrimary • Rate of death from any cause at 1 year in the intention-to-treat population.

  10. Study EndpointsSecondary • 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

  11. Results • The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) • and 24.2% and 26.8%, respectively, at 1 year (P=0.44), • a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority).

  12. The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). • At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001)

  13. adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). • More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.

  14. Patients in the transcatheter group had a significantly shorter length of stay in the intensive care unit (3 days, vs. 5 days in the surgical group) and • a shorter index hospitalization (8 vs. 12 days) (P<0.001 for both comparisons).

  15. Summary • ?Favourable mortality offset by post procedural stroke rates. • Early device systems • Scarcity of the procedure

More Related