Presentation is loading. Please wait.

Presentation is loading. Please wait.

Highlights From the SAPIEN 3 Experience in Intermediate-Risk Patients Vinod H. Thourani, MD on behalf of the PARTNER Trial Investigators Professor.

Published byAbel Bruce Modified over 6 years ago

Similar presentations

Presentation on theme: "Highlights From the SAPIEN 3 Experience in Intermediate-Risk Patients Vinod H. Thourani, MD on behalf of the PARTNER Trial Investigators Professor."— Presentation transcript:

1 Highlights From the SAPIEN 3 Experience in Intermediate-Risk Patients Vinod H. Thourani, MD on behalf of the PARTNER Trial Investigators Professor of Surgery and Medicine Chief of Cardiothoracic Surgery, Emory Midtown Hospital Co-Director, Structural Heart and Valve Center Emory University School of Medicine Atlanta, Georgia, USA

2 Disclosure Statement of Financial Interest
Vinod H. Thourani, MD Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Boston Scientific, Claret Medical, Edwards Lifesciences, Medtronic, St. Jude Medical Abbott Vascular, Edwards Lifesciences, St. Jude Medical None

3 SAPIEN Platforms in PARTNER Device Evolution
Valve Technology SAPIEN SAPIEN XT SAPIEN 3 Sheath Compatibility Available Valve Sizes 23 mm 26 mm 20 mm 29 mm 22-24F 16-20F 14-16F 29 mm 23 mm 26 mm

4 SAPIEN 3 Commander Delivery System Distinguishing Features
Improved coaxial alignment Accurate positioning Fine control of valve positioning Distal flex SAPIEN 3 Valve Size 20 mm 23 mm 26 mm 29 mm Expandable Sheath 14F 16F Minimum Access Vessel Diameter 5.5 mm 6.0 mm

5 The PARTNER II S3 Trial: S3i Participating Sites
1076 Patients Enrolled at 51 US Participating Sites 5

6 The PARTNER 2A and S3i Trials Study Design
Intermediate Risk Symptomatic Severe Aortic Stenosis Intermediate Risk ASSESSMENT by Heart Valve Team TF TAVR SAPIEN 3 TA/TAo TAVR P2 S3i n = 1078 ASSESSMENT: Optimal Valve Delivery Access Transapical / Transaortic (TA/TAo) Transfemoral (TF) SAVR P2A n = 2032 ASSESSMENT: Transfemoral Access Transapical / TransAortic (TA/TAo) Transfemoral (TF) 1:1 Randomization Yes No TF TAVR SAPIEN XT VS TA/Tao TAVR SAPIEN 3 Primary Endpoint: All-Cause Mortality, All Stroke, or Mod/Sev AR at One Year (Non-inferiority Propensity Score Analysis)

7 The PARTNER 2A and S3i Trials Inclusion Criteria
• Severe AS: Echo-derived AVA ≤ 0.8 cm2 (or AVA index < 0.5 cm2/m2) and mean AVG > 40 mmHg or peak jet velocity > 4.0 m/s • Cardiac Symptoms: NYHA Functional Class ≥ II Intermediate Risk: Determined by a multi-disciplinary Heart Team Using a guideline STS between 4-8%*, and Adjudicated by case review committee * PARTNER 2A used guideline STS ≥ 4%

8 The PARTNER 2A and S3i Trials Primary Endpoint and Methodology
Non-hierarchical composite of all-cause mortality, all stroke, or ≥ moderate AR at 1 year Propensity score analysis of the VI populations from S3i compared to the surgical arm of the PARTNER 2A trial All patients followed for at least 1 year, event rates by Kaplan-Meier estimates Non-inferiority trial design followed by superiority testing for the primary endpoint and components was performed Methodology Systematic assessment by neurologists before and after index procedures for ascertainment of neurologic events MDCT evaluation of annulus dimensions for all TAVR S3i patients (with core laboratory analyses) CEC adjudication of major clinical events (VARC 2 definitions whenever possible)

9 Baseline Patient Characteristics Demographics (AT)
TAVR (n = 1077) Surgery (n = 944) p-value Age - yrs 81.9 ± 6.6 81.6 ± 6.8 0.23 Male - % 61.7 55.0 0.002 BMI - kg/m2 28.7 ± 6.1 28.4 ± 6.2 0.32 Median STS Score - % 5.2 [4.3, 6.3] 5.4 [4.4, 6.7] 0.0002 NYHA Class III or IV - % 72.5 76.1 0.07 mean ± SD, median [IQR]

10 Baseline Patient Characteristics Other Co-morbidities (AT)
TAVR (n = 1077) Surgery (n = 944) p-value CAD 69.6 66.5 0.14 Previous CABG 27.9 25.7 0.27 Cerebrovascular Disease 9.0 10.3 0.36 PVD 28.2 32.2 0.05 COPD 30.0 30.2 0.92 Cr level > 2 mg/dL 7.5 5.4 0.06 Atrial Fibrillation 36.0 34.9 0.61 Permanent Pacemaker 13.2 12.0 0.42 15 ft Walk Test > 7s 41.3 45.7

11 Statistical Analysis Plan
Pre-specified propensity score analysis of SAPIEN 3 TAVR vs. P2A surgery for the composite primary endpoint (all- cause mortality, all stroke, or total AR ≥ moderate at 1 year). The analysis incorporated 22 pre-specified baseline characteristics that were factored through a logistic regression into a propensity score. Patient population was divided into quintiles based on propensity scores. Quintile stratification (unlike patient matching) allows for the use of data from all patients, minimizing selection bias.

12 Quintile Propensity Score Analysis: Primary Endpoint
Surgery TAVR # Patients Mortality, Stroke, AR > Mod 191 28.3% 138 13.8% Proportion Difference -14.5% Weighting 0.14 175 22.9% 171 9.9% -12.9% 0.18 147 19.7% 197 10.7% 147 19.7% 197 10.7% -9.1% -9.1% 0.20 0.20 126 23.0% 219 14.6% -8.4% 0.23 108 19.4% 238 15.1% -4.3% 0.25 Overall weighted difference of proportions - 9.2% [-12.4%,-6.0%] two-sided 90% CI

13 Primary Endpoint - Non-inferiority Death, Stroke, or AR ≥ Mod at 1 Year (VI)
Weighted Difference % Upper 1-sided 95% CI -6.0% Non-Inferiority p-value < 0.001 Pre-specified non-inferiority margin = 7.5% -10 -8 -6 -4 -2 2 4 6 8 10 Favors TAVR Favors Surgery Primary Non-Inferiority Endpoint Met

14 Weighted Difference -9.2%
Primary Endpoint - Superiority Death, Stroke, or AR ≥ Mod at 1 Year (VI) Weighted Difference % Upper 2-sided 95.0% CI -5.4% Superiority Testing p-value < 0.001 -10 -8 -6 -4 -2 2 4 6 8 10 Favors TAVR Favors Surgery Superiority Achieved

15 Superiority Analysis Components of Primary Endpoint (VI)
Favors TAVR Favors Surgery Weighted Difference % Upper 2-sided 95% CI -2.4% Superiority Testing p-value < 0.001 Mortality -10 -8 -6 -4 -2 2 4 6 8 10 Weighted Difference % Upper 2-sided 95% CI -1.1% Superiority Testing p-value = 0.004 Stroke -10 -8 -6 -4 -2 2 4 6 8 10 Weighted Difference % Lower 2-sided 95% CI +0.2% Superiority Testing p-value = AR > Moderate -10 -8 -6 -4 -2 2 4 6 8 10

16 Unadjusted Clinical Events At 30 Days and 1 Year (AT)
TAVR Surgery Death All-cause 1.1 4.0 7.4 13.0 Cardiovascular 0.9 3.1 4.5 8.1 Neurological Events Disabling Stroke 1.0 4.4 2.3 5.9 All Stroke 2.7 6.1 4.6 8.2 All-cause Death and Disabling Stroke 2.0 8.0 8.4 16.6

17 Unadjusted Time-to-Event Analysis All-Cause Mortality and All Stroke (AT)
10 20 30 40 P2A Surgery SAPIEN 3 TAVR 18.8% All-Cause Mortality / Stroke Rate (%) 10.8% 9.7% TF = 9.9% mortality at 1 year 3.7% 3 6 9 12 Months from Procedure Number at risk: P2A Surgery 944 805 786 757 743 S3 TAVR 1077 1012 987 962 930

18 Unadjusted Time-to-Event Analysis All-Cause Mortality (AT)
10 20 30 40 P2A Surgery SAPIEN 3 TAVR TF = 6.5% mortality at 1 year All-Cause Mortality (%) 13.0% 4.0% 7.4% 1.1% 3 6 9 12 Months from Procedure Number at risk: P2A Surgery 944 859 836 808 795 S3 TAVR 1077 1043 1017 991 963

19 Unadjusted Time-to-Event Analysis All Stroke (AT)
10 20 30 40 P2A Surgery SAPIEN 3 TAVR TF = 4.3% mortality at 1 year All Stroke (%) 8.2% 6.1% 4.6% 2.7% 3 6 9 12 Months from Procedure Number at risk: P2A Surgery 944 805 786 757 743 S3 TAVR 1077 1012 987 962 930

20 Other Unadjusted Clinical Outcomes At 30 Days and 1 Year (AT)
Events (%) 30 Days 1 Year TAVR (n = 1077) Surgery (n = 944) Re-hospitalization 4.6 6.8 11.4 15.1 MI 0.3 1.9 1.8 3.1 Major Vascular Complication 6.1 5.4 --- AKI (Stage III) 0.5 3.3 Life-Threatening/Disabling Bleeding 46.7 New Atrial Fibrillation 5.0 28.3 5.9 29.2 New Permanent Pacemaker 10.2 7.3 12.4 9.4 Re-intervention 0.1 0.0 0.6 Endocarditis 0.2 0.8 0.7

21 Paravalvular Regurgitation 3-Class Grading Scheme (VI)
≥ Moderate 1.5% Mild 39.8% No. of echos 30 Days 1 Year P2A Surgery 755 610 S3i TAVR 992 875

22 Mortality by PVR Severity S3i (VI)
10 20 30 40 Moderate/Severe Overall p (Log-Rank) = Mild None/Trace Mod/Sev (reference = None/Trace) p (Log-Rank) p = Mild (reference = None/Trace) p (Log-Rank) = All-Cause Mortality (%) 13.3% 6.4% 4.5% 3 6 9 12 Months from Procedure Number at risk: Mod/Sev 38 37 36 33 31 Mild 446 440 430 419 406 None/Trace 508 503 492 484 474

23 Echocardiographic Findings: Mean Gradients (VI)
No. of Echos SAPIEN 3 SAPIEN mm SAPIEN mm SAPIEN mm SAPIEN mm 840 35 276 372 157

24 The PARTNER 2A and S3i Trials Conclusions - 1
In IR patients, SAPIEN 3 TAVR resulted in low 1-year rates of: all-cause mortality = 7.4% (TF is 6.5%) all stroke = 4.6% (TF is 4.3%) and moderate or severe aortic regurgitation (1.5%)

25 The PARTNER 2A and S3i Trials Conclusions - 2
The rigorous propensity score analysis comparing SAPIEN 3 with SAVR in IR patients at 1 year demonstrated: Non-inferiority for the primary endpoint (composite of all-cause mortality, all stroke, or AR ≥ moderate) Superiority of SAPIEN 3 TAVR for the primary endpoint, all- cause mortality, and all stroke Superiority of surgery for AR ≥ moderate Time-to-event analyses indicated that the benefits of SAPIEN 3 TAVR occurred in the first few months, suggesting procedure-related effects

26 The PARTNER 2A and S3i Trial Clinical Implications
The conclusions from the PARTNER 2A randomized trial and this propensity score analysis provide strong evidence that in intermediate-risk patients with severe aortic stenosis, SAPIEN 3 TAVR when compared with surgery improves clinical outcomes and is the preferred therapy.

27 The PARTNER 2A and S3i Trial The Lancet On-line
Special thanks to the PARTNER sites, the patients, the clinical research teams, and the manuscript writing group!

Download ppt "Highlights From the SAPIEN 3 Experience in Intermediate-Risk Patients Vinod H. Thourani, MD on behalf of the PARTNER Trial Investigators Professor."

Similar presentations

STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic.

STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic.
Three-year clinical and echocardiographic follow-up of aortic stenosis patients implanted with a self-expending bioprosthesis Sabine Bleiziffer German.

Three-year clinical and echocardiographic follow-up of aortic stenosis patients implanted with a self-expending bioprosthesis Sabine Bleiziffer German.
ACC 2015 Michael J Reardon, MD, FACC On Behalf of the CoreValve US Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic.

ACC 2015 Michael J Reardon, MD, FACC On Behalf of the CoreValve US Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic.
Lessons from TAVR Randomized Trials and Registries E Murat Tuzcu, MD Professor of Medicine Cleveland Clinic Financial disclosures: None PARTNER Executive.

Lessons from TAVR Randomized Trials and Registries E Murat Tuzcu, MD Professor of Medicine Cleveland Clinic Financial disclosures: None PARTNER Executive.
One Year Outcomes in Real World Patients Treated with Transcatheter Aortic Valve Implantation The ADVANCE Study Axel Linke University of Leipzig Heart.

One Year Outcomes in Real World Patients Treated with Transcatheter Aortic Valve Implantation The ADVANCE Study Axel Linke University of Leipzig Heart.
University Heart Center Hamburg

University Heart Center Hamburg
The Risk and Extent of Neurological Events Are Equivalent for High-Risk Patients Treated With Transcatheter or Surgical Aortic Valve Replacement Thomas.

The Risk and Extent of Neurological Events Are Equivalent for High-Risk Patients Treated With Transcatheter or Surgical Aortic Valve Replacement Thomas.
Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III.

Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III.
Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis David H. Adams et al (U.S. CoreValve Clinical Investigators) Journal Club November.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis David H. Adams et al (U.S. CoreValve Clinical Investigators) Journal Club November.
Axel Linke University of Leipzig Heart Center, Leipzig, Germany Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital.

Axel Linke University of Leipzig Heart Center, Leipzig, Germany Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital.
Techniques in Valve-in-Valve TAVR Vinod H. Thourani, MD Professor of Surgery and Medicine Chief of Cardiothoracic Surgery, Emory Hospital Midtown Co-Director:

Techniques in Valve-in-Valve TAVR Vinod H. Thourani, MD Professor of Surgery and Medicine Chief of Cardiothoracic Surgery, Emory Hospital Midtown Co-Director:
TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.

TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.
TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.

TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.
Determination of the RAdial versus GrOiN coronary angioplasty The Result of DRAGON Trial Shigeru Saito, MD Department of Cardiology and Catheterization.

Determination of the RAdial versus GrOiN coronary angioplasty The Result of DRAGON Trial Shigeru Saito, MD Department of Cardiology and Catheterization.
The Impact of Prior Stroke on the Outcome of Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Romain Didier, MD;

The Impact of Prior Stroke on the Outcome of Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Romain Didier, MD;
UC201300969c EN. Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125.

UC c EN. Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125.
Martin B. Leon, MD on behalf of the PARTNER Investigators TCT 2010; Washington, DC; September 23, 2010 Transcatheter Aortic Valve Implantation in Inoperable.

Martin B. Leon, MD on behalf of the PARTNER Investigators TCT 2010; Washington, DC; September 23, 2010 Transcatheter Aortic Valve Implantation in Inoperable.
TCT 2015 | San Francisco | October 15, 2015 Howard C. Herrmann, MD on behalf of The PARTNER II Trial Investigators SAPIEN 3: Evaluation of a Balloon- Expandable.

TCT 2015 | San Francisco | October 15, 2015 Howard C. Herrmann, MD on behalf of The PARTNER II Trial Investigators SAPIEN 3: Evaluation of a Balloon- Expandable.
Vinod H. Thourani, MD on behalf of The PARTNER Trial Investigators

Vinod H. Thourani, MD on behalf of The PARTNER Trial Investigators
G. Michael Deeb, MD On Behalf of the US Pivotal Trial Investigators 3-Year Results From the US Pivotal High Risk Randomized Trial Comparing Self-Expanding.

G. Michael Deeb, MD On Behalf of the US Pivotal Trial Investigators 3-Year Results From the US Pivotal High Risk Randomized Trial Comparing Self-Expanding.

Similar presentations

Ads by Google