Lessons from TAVR Randomized Trials and Registries E Murat Tuzcu, MD Professor of Medicine Cleveland Clinic Financial disclosures: None PARTNER Executive.

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Presentation transcript:

Lessons from TAVR Randomized Trials and Registries E Murat Tuzcu, MD Professor of Medicine Cleveland Clinic Financial disclosures: None PARTNER Executive Committee member

Edwards Transcatheter Valve Evolution Untreated Equine Tissue Edwards SAPIEN™ August, 2007 Treated Bovine Tissue Andersen Pig implant, May ’89 Cribier-Edwards™ FIM, April 2002 Sapien XT™ January, 2010 TFX Treated Bovine /CC Untreated Equine Tissue

CoreValve Revalving Generation 1 25 Fr Generation 2 21 Fr Generation 3 18 Fr Dec 2006 No Support No Anesthesia (June) CP By-Pass + TandemHeart Percutaneous Support Surgical Fem-Fem CP By-Pass

30-day Mortality Study (%) REVIVE/REVIVAL a VANCOUVER b PARTNER EU c SOURCE d CANADIAN e FRENCH Reg f UK Reg g n Age Mortality (%) ES/STS34.3/ /-25.7/ /--/ / Transfemoral TAVI a. Kodali et al TCT 2008 b. Webb TCT 2008 c. Schachinger et al Euro PCR 2009 d. Thomas et al Euro PCR 2009 e. Rodes-Cabau et al. JACC 2010;55:In Press f. Eltchaninoff H. AHA 2009 g. LudmanEuroPCR 2010

REVIVAL VANCOUVER CANADIAN UK Registry Month SOURCE % 73.8% 81.1% 75.0% 79.5% One Year Survival Transfemoral TAVI

N = 699 N = 358 High Risk Inoperable PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients 2 Parallel Trials: Individually Powered Standard Therapy Standard Therapy ASSESSMENT: Transfemoral Access Not In Study TF TAVR Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) 1:1 Randomization VS Yes No N = 179

All Cause Mortality Numbers at Risk TAVI TAVI Standard Rx Standard Rx ∆ at 1 yr = 20.0% NNT = 5.0 pts Standard Rx TAVI All-cause mortality (%) Months % 30.7% HR [95% CI] = 0.54 [0.38, 0.78] P (log rank) <

TAVI Standard RxTAVIStandard RxTAVIStandard RxTAVIStandard Rx DeadIIIIIIIV Percent NYHA Class Over Time All patients TreatmentVisit P = 0.68P <

Aortic Valve Mean Gradient (Core Lab) (mmHg) * * * * Douglas et al ACC 2011

Clinical Outcomes at 30 Days and 1 Year Major Vascular Complications P< TAVI (n=179) Standard Rx (n=179) per cent Major Stroke P = 0.06 P = 0.18

Published Cost Effectiveness Estimates

Clinical Implications Balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery!

N = 179 N = 358 Inoperable Standard Therapy Standard Therapy ASSESSMENT: Transfemoral Access Not In Study TF TAVR Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) 1:1 Randomization VS Yes No N = 179 TF TAVR AVR Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) TA TAVR AVR VS N = 248N = 104N = 103N = 244 PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients 2 Parallel Trials: Individually Powered N = 699 High Risk ASSESSMENT: Transfemoral Access Transapical (TA) Transfemoral (TF) 1:1 Randomization Yes No

1 Year (189) Dead = 46 Withdrawal = 1 1 Year (189) Dead = 46 Withdrawal = 1 1 Year (168) Dead = 47 Withdrawal = 8 1 Year (168) Dead = 47 Withdrawal = 8 Study Flow AVR (248) 30 Days (236) Dead = 8 Withdrawal = 0 30 Days (236) Dead = 8 Withdrawal = 0 Randomized = 699 patients TF = 492 TA = 207 Transfemoral n = 492 TAVR (244) 30 Days (223) Dead = 15 Withdrawal = Days (223) Dead = 15 Withdrawal = 10 1 Year (73) Dead = 26 Withdrawal = 0 LTFU = 1 1 Year (73) Dead = 26 Withdrawal = 0 LTFU = 1 1 Year (68) Dead = 20 Withdrawal = 3 LTFU = 1 1 Year (68) Dead = 20 Withdrawal = 3 LTFU = 1 AVR (103) 30 Days (100) Dead = 4 Withdrawal = 0 30 Days (100) Dead = 4 Withdrawal = 0 Transapical n = 207 TAVR (104) 30 Days (92) Dead = 7 Withdrawal = 4 30 Days (92) Dead = 7 Withdrawal = 4

CharacteristicTAVR (N = 348)AVR (N = 351)p-value Age (yr)83.6 ± ± Male sex - % STS Score11.8 ± ± Logistic EuroSCORE29.3 ± ± NYHA II - % III or IV - % CAD - % Previous MI - % Prior CV Intervention - % Prior CABG - % Prior PCI - % Prior BAV - % Patient Characteristics (1) Cerebrovascular disease - %

Characteristic TAVR (N = 348) AVR (N = 351) p-value Peripheral vascular disease - % COPD Any 43.4 Oxygen dependent Creatinine> 2mg/dL - % Atrial fibrillation - % Permanent pacemaker - % Pulmonary hypertension - % Frailty - % Porcelain aorta - % Chest wall radiation - % Liver disease - % Patient Characteristics (2)

TAVR AVR Months No. at Risk TAVR AVR Primary Endpoint: All-Cause Mortality at 1 Year HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = 0.62

30 Days 1 Year Outcome TAVR (N = 348) AVR (N = 351) p-value TAVR (N = 348) AVR (N = 351) p-value Vascular complications All – no. (%) 59 (17.0) 13 (3.8) < (18.0) 16 (4.8) <0.01 Major – no. (%) 38 (11.0) 11 (3.2) < (11.3) 12 (3.5) <0.01 Major bleeding – no. (%) 32 (9.3) 67 (19.5) < (14.7) 85 (25.7) <0.01 Endocarditis – no. (%) 0 (0.0) 1 (0.3) (0.6) 3 (1.0) 0.63 New AF – no. (%) 30 (8.6) 56 (16.0) < (12.1) 60 (17.1) 0.07 New PM – no. (%) 13 (3.8) 12 (3.6) (5.7) 16 (5.0) 0.68 Clinical Outcomes at 30 Days and 1 Year All Patients (N=699)

30 Days 1 Year Outcome TAVR (N = 348) AVR (N = 351) TAVR (N = 348) AVR (N = 351) All Stroke or TIA – no. (%) 19 (5.5) 8 (2.4) (8.3) 13 (4.3) 0.04 TIA – no. (%)3 (0.9)1 (0.3)0.337 (2.3)4 (1.5)0.47 All Stroke – no. (%)16 (4.6)8 (2.4) (6.0)10 (3.2)0.08 Major Stroke – no. (%) 13 (3.8) 7 (2.1) (5.1) 8 (2.4) 0.07 Minor Stroke – no. (%)3 (0.9)1 (0.3)0.343 (0.9)2 (0.7)0.84 Death/maj stroke – no. (%) 24 (6.9) 28 (8.2) (26.5) 93 (28.0) 0.68 Neurological Events at 30 Days and 1 Year All Patients (N=699) p-value

0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. The Modified Rankin Scale Minor Major

All-Cause Mortality at 30 Days All Patients no. of patients ( %) TF Patients no. of patients ( %) TA Patients no. of patients ( %) TAVRAVRp-valueTAVRAVRp-valueTAVRAVRp-value ITT12 (3.4)22 (6.5)0.078 (3.3)15 (6.2)0.134 (3.8)7 (7.0)0.32 AT18 (5.2)25 (8.0)0.159 (3.7)18 (8.2) (8.7)7 (7.6)0.79 Mortality and Major Stroke at 30 Days Major Stroke at 30 Days All Patients no. of patients ( %) TF Patients no. of patients ( %) TA Patients no. of patients ( %) TAVRAVRp-valueTAVRAVRp-valueTAVRAVRp-value ITT13 (3.8)7 (2.1)0.207 (2.9)4 (1.7)0.376 (5.8)3 (3.2)0.37 AT13 (3.8)7 (2.3)0.256(2.5)3 (1.4)0.377 (7.0)4 (4.4)0.45

All-Cause Mortality at 1 Year All Patients no. of patients ( %) TF Patients no. of patients ( %) TA Patients no. of patients ( %) TAVRAVRp-valueTAVRAVRp-valueTAVRAVRp-value ITT84 (24.2)89 (26.8) (22.2)62 (26.4) (29.0)27 (27.9)0.85 AT81 (23.7)78 (25.2) (21.3)55 (25.2) (29.1)23 (25.3)0.55 Major Stroke at 1 Year All Patients no. of patients ( %) TF Patients no. of patients ( %) TA Patients no. of patients ( %) TAVRAVRp-valueTAVRAVRp-valueTAVRAVRp-value ITT17 (5.1)8 (2.4)0.079 (3.8)4(1.7)0.158 (8.3)4 (4.3)0.26 AT17 (5.2)8 (2.7)0.118 (3.5)3(1.4)0.159 (9.4)5(5.9)0.37 Mortality and Major Stroke at 1 year

TAVR Neuro Events in PARTNER B Number of Events strokes 0-3 day 8 strokes occurred when patients were in AF

Paravalvular Aortic Regurgitation P< Year6 Months30 Days Patients, % NoneTraceMildModerate Severe

Implications TAVR is an acceptable alternative to AVR in selected high-risk operable patients. A multidisciplinary valve team benefits patients and recommended for all valve centers. Future RCT should focus on lower risk patients who are candidates for operation.