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Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER 1 Trial Michael J. Mack, MD.

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Presentation on theme: "Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER 1 Trial Michael J. Mack, MD."— Presentation transcript:

1 Five-Year Outcomes after Randomization to Transcatheter or Surgical Aortic Valve Replacement: Final Results of The PARTNER 1 Trial Michael J. Mack, MD on behalf of The PARTNER Trial Investigators ACC | San Diego | March 15, 2015

2 Conflict of Interest Disclosure
Member of the Executive Committee of the Trial Uncompensated; travel expenses paid for committee meetings

3 PARTNER 1 Trial Executive Committee

4 PARTNER Study Design N = 699 High Risk Inoperable N = 358
Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 179 N = 358 Inoperable 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) 1:1 Randomization VS Yes No Total = 1,057 patients High Risk N = 699 2 Parallel Trials: Individually Powered ASSESSMENT: Transfemoral Access Transapical (TA) Transfemoral (TF) 1:1 Randomization Yes No TF TAVR SAVR Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) TA TAVR VS N = 248 N = 104 N = 103 N = 244

5 Study Devices Transfemoral Transapical Edwards SAPIEN THV RetroFlex 1
23 and 26 mm valves RetroFlex 1 22 and 24 F sheaths Ascendra 24 and 26 F sheaths

6 Study Devices Transfemoral Transapical Edwards SAPIEN THV RetroFlex 1
23 and 26 mm valves RetroFlex 1 22 and 24 F sheaths Ascendra 24 and 26 F sheaths

7 Key 5-Year Results Mortality Assessments (Primary Endpoint at 1 Year)
Valve Performance (Echocardiography) Mean Gradient Effective Orifice Area Left Ventricular Mass Index Strokes Other Clinical Outcomes Rehospitalization NYHA Functional Class Paravalvular Leak

8 Study Methodology All patients followed ≥ 5years
Primary analysis: intention-to-treat (ITT) Valve implant analysis for echo data Event rates: Kaplan-Meier estimates All analyses: pre-specified Effect of baseline variables on five year mortality Cox proportional hazards regression (multivariable analysis with covariates p-value < 0.20)

9 Baseline Patient Characteristics Demographics
TAVR (n=348) SAVR (n=351) n Age – years (Mean ± SD) 348 83.6 ± 6.8 349 84.5 ± 6.4 Male 201 57.8% 198 56.7% NYHA Class III or IV 328 94.3% 94.0% Previous CABG 148 42.5% 152 43.6% Cerebrovascular disease 96 29.4% 87 26.8% Peripheral vascular disease 149 43.2% 142 41.6% STS Score (Mean ± SD) 347 11.8 ± 3.3 11.7 ± 3.5

10 Study Flow Randomized = 699 patients Follow-up Compliance
Transfemoral n = 492 TF = 492 (70%) TA = 207 (30%) Transapical n = 207 TAVR (244) SAVR (248) TAVR (104) SAVR (103) 5 Years Alive = 81 Dead = 150 LTFU = 4 Withdrawal = 3 Censored* = 6 5 Years Alive = 69 Dead = 142 LTFU = 10 Withdrawal = 19 Censored* = 8 5 Years Alive = 21 Dead = 79 LTFU = 1 Withdrawal = 1 Censored* = 2 5 Years Alive = 33 Dead = 56 LTFU = 2 Withdrawal = 11 Censored* = 1 Compliance with withdrawals removed from computation. Follow-up Compliance Follow-up Compliance 98.3% 95.6% 99.0% 97.8% * Censored = Patient alive at last contact but no information available within FU window

11 All-Cause Mortality (ITT) All Patients
HR [95% CI] = 1.04 [0.86, 1.24] p (log rank) = 0.76 67.8% 62.4% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 348 262 228 191 154 61 SAVR 351 236 210 174 131 64

12 Cardiovascular Mortality (ITT) All Patients
HR [95% CI] = 1.05 [0.83, 1.33] p (log rank) = 0.67 53.1% 47.6% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 348 262 228 191 154 61 SAVR 351 236 210 174 131 64

13 Median Survival All Patients
40.6 Months p (log rank) = 0.76 Trial p-value. Non-comparative. 44.5 Months Months

14 All-Cause Mortality (ITT) Transfemoral Patients
HR [95% CI] = 0.91 [0.72, 1.14] p (log rank) = 0.41 63.3% 63.3% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 244 189 167 141 115 50 SAVR 248 168 150 125 93 46

15 Multivariate Baseline Predictors of Mortality (ITT) – All Patients
Hazard Ratio [95% CI] p-value Assignment to TAVR 1.09 [ ] 0.39 Body-Mass Index 0.96 [ ] <0.001 Creatinine Level 1.41 [ ] Liver Disease 2.31 [ ] Mean Gradient (Per Increase 10 mm Hg) 0.91 [ ] 0.004 Atrial Fibrillation 1.37 [ ]

16 Subgroup Analysis All-Cause Mortality
Hazard Ratio for TAVR [95% CI] Interaction p-value Overall (N=699) 1.03 [ ] Age < 85 (N=358) 1.00 [ ] 0.71 ≥ 85 (N=339) 1.07 [ ] Sex Male (N=399) 1.20 [ ] 0.07 Female (N=300) 0.84 [ ] BMI ≤ 25 (N=302) 1.17 [ ] 0.39 > 25 (N=390) 0.99 [ ] STS ≤ 11 (N=353) 0.95 [ ] 0.38 > 11 (N=346) 1.12 [ ] TAVR Better SAVR Better

17 Subgroup Analysis All-Cause Mortality
Hazard Ratio for TAVR [95% CI] Interaction p-value Overall (N=699) 1.03 [ ] Peripheral Vasc. Dis. No (N=395) 0.79 [ ] <0.01 Yes (N=291) 1.49 [ ] Pulmonary Hypertension No (N=360) 1.32 [ ] 0.01 Yes (N=337) 0.76 [ ] Mod / Sev MR No (N=536) 1.11 [ ] 0.11 Yes (N=133) 0.77 [ ] Prior CABG or PCI No (N=283) 0.85 [ ] 0.10 Yes (N=414) 1.17 [ ] Implant Approach Transapical (N = 207) 1.37 [ ] 0.05 Transfemoral (N = 492) 0.91 [ ] TAVR Better SAVR Better

18 Aortic Valve Mean Gradient
Error Bars = ± 1 Std Dev p < No structural valve deterioration that required re-intervention. TAVR 310 219 156 106 79 56 SAVR 299 158 123 86 61 48

19 Aortic Valve Area p < 0.0001 TAVR 304 211 151 106 79 53 SAVR 294
Error Bars = ± 1 Std Dev TAVR 304 211 151 106 79 53 SAVR 294 154 121 84 60 46

20 LV Mass Index p < 0.0001 TAVR 278 186 134 94 70 48 SAVR 268 138 105
Error Bars = ± 1 Std Dev p < TAVR 278 186 134 94 70 48 SAVR 268 138 105 77 53 43

21 All Stroke (ITT) All Patients
HR [95% CI] = 1.14 [0.68, 1.93] p (log rank) = 0.61 Error Bars Represent 95% Confidence Limits 11.3% 10.4% No. at Risk TAVR 348 251 217 181 144 57 SAVR 351 230 205 169 128 64

22 All-Cause Mortality or Stroke (ITT) All Patients
HR [95% CI] = 1.09 [0.90, 1.31] p (log rank) = 0.39 69.8% 62.9% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 348 251 217 181 144 57 SAVR 351 230 205 169 128 64

23 NYHA Over Time (ITT) Survivors
p = 0.64 p = 0.91 p = 0.35 p = 0.93 13% 14% 15% 19% 20% 15% 94% 94%

24 Rehospitalization (ITT) All Patients
HR [95% CI] = 1.22 [0.92, 1.63] p (log rank) = 0.17 42.3% 34.2% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 348 225 183 149 114 40 SAVR 351 200 172 140 107 50

25 Mortality and Post Procedural PVL TAVR Patients
p (log rank) = 75.7% 73.0% 58.6% No. at Risk M-S 24 16 13 12 7 2 Mild 137 98 84 65 52 11 N-T 158 135 120 105 88 34

26 Mortality and None-Trace Total AR Transfemoral Patients
HR [95% CI] = 0.64 [0.43, 0.95] p (log rank) = 0.03 60.9% 45.2% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 70 65 55 51 43 19 SAVR 181 137 126 105 78 36

27 Summary At five years in The PARTNER 1A Trial of high surgical risk patients with severe aortic stenosis randomized to TAVR or SAVR there was no significant difference in: All-Cause and Cardiovascular Mortality Strokes NYHA Class Rehospitalization Valve Hemodynamics No structural valve deterioration requiring re-intervention in TAVR patients. The presence of ≥ mild paravalvular leak is associated with decreased survival.

28 Conclusions Five year follow-up of patients in The PARTNER Trial supports TAVR as an alternative to surgery in high surgical risk patients with similar mortality and other major clinical outcomes including stroke. Improvements in valve function were maintained for five years in both groups.

29

30 Dedicated to Mike Davidson

31 Dedicated to the Memory of Mike Davidson, a Cherished Member of Our PARTNER Team

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