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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 2015 | San Diego | March 15, 2015

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

3 PARTNER 1 Trial Executive Committee

4 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 YesNo N = 179 TF TAVRSAVR Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) TA TAVRSAVR VS N = 248N = 104N = 103N = 244 PARTNER Study Design Symptomatic Severe Aortic Stenosis 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 YesNo

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

6 Study Devices Transfemoral Transapical Edwards SAPIEN THV 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)Mortality Assessments (Primary Endpoint at 1 Year) Valve Performance (Echocardiography)Valve Performance (Echocardiography) –Mean Gradient –Effective Orifice Area –Left Ventricular Mass Index StrokesStrokes Other Clinical OutcomesOther Clinical Outcomes –Rehospitalization –NYHA Functional Class Paravalvular LeakParavalvular Leak

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

9 Baseline Patient Characteristics Demographics Characteristic TAVR (n=348) SAVR (n=351) nn Age – years (Mean ± SD) ± ± 6.4 Male % % NYHA Class III or IV % % Previous CABG % % Cerebrovascular disease9629.4%8726.8% Peripheral vascular disease % % STS Score (Mean ± SD) ± ± 3.5

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

11 All-Cause Mortality (ITT) All Patients No. at Risk HR [95% CI] = 1.04 [0.86, 1.24] p (log rank) = 0.76 TAVR SAVR % 67.8% Error Bars Represent 95% Confidence Limits

12 Cardiovascular Mortality (ITT) All Patients No. at Risk HR [95% CI] = 1.05 [0.83, 1.33] p (log rank) = 0.67 TAVR SAVR % 53.1% Error Bars Represent 95% Confidence Limits

13 Months 40.6 Months 44.5 Months p (log rank) = 0.76 Median Survival All Patients

14 TAVR SAVR All-Cause Mortality (ITT) Transfemoral Patients No. at Risk HR [95% CI] = 0.91 [0.72, 1.14] p (log rank) = % Error Bars Represent 95% Confidence Limits

15 Multivariate Baseline Predictors of Mortality (ITT) – All Patients PredictorHazard Ratio [95% CI]p-value Assignment to TAVR1.09 [ ]0.39 Body-Mass Index 0.96 [ ]<0.001 Creatinine Level1.41 [ ]<0.001 Liver Disease2.31 [ ]<0.001 Mean Gradient (Per Increase 10 mm Hg)0.91 [ ]0.004 Atrial Fibrillation1.37 [ ]0.004

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

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

18 Aortic Valve Mean Gradient TAVR SAVR Error Bars = ± 1 Std Dev No structural valve deterioration that required re-intervention. p <

19 Aortic Valve Area TAVR SAVR Error Bars = ± 1 Std Dev p <

20 LV Mass Index TAVR SAVR Error Bars = ± 1 Std Dev p <

21 All Stroke (ITT) All Patients No. at Risk HR [95% CI] = 1.14 [0.68, 1.93] p (log rank) = 0.61 TAVR SAVR % 10.4% Error Bars Represent 95% Confidence Limits

22 All-Cause Mortality or Stroke (ITT) All Patients No. at Risk HR [95% CI] = 1.09 [0.90, 1.31] p (log rank) = 0.39 TAVR SAVR % 69.8% Error Bars Represent 95% Confidence Limits

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

24 Rehospitalization (ITT) All Patients No. at Risk HR [95% CI] = 1.22 [0.92, 1.63] p (log rank) = 0.17 TAVR SAVR % 42.3% Error Bars Represent 95% Confidence Limits

25 M-S Mild N-T Mortality and Post Procedural PVL TAVR Patients No. at Risk p (log rank) = % 58.6% 73.0%

26 No. at Risk HR [95% CI] = 0.64 [0.43, 0.95] p (log rank) = 0.03 TAVR SAVR % 45.2% Error Bars Represent 95% Confidence Limits Mortality and None-Trace Total AR Transfemoral Patients

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: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.No structural valve deterioration requiring re-intervention in TAVR patients. The presence of ≥ mild paravalvular leak is associated with decreased survival.The presence of ≥ mild paravalvular leak is associated with decreased survival.

28 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.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.Improvements in valve function were maintained for five years in both groups. Conclusions

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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