Health Status Benefits of Transcatheter vs. Surgical Aortic Valve - - PowerPoint PPT Presentation

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Health Status Benefits of Transcatheter vs. Surgical Aortic Valve - - PowerPoint PPT Presentation

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Health Status Benefits of Transcatheter vs. Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis at Intermediate Surgical Risk Results From The PARTNER 2 Trial David J. Cohen, M.D., M.Sc. On behalf of the PARTNER 2

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TCT 2016 | Washington, DC | November 1, 2016

Health Status Benefits of Transcatheter vs. Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis at Intermediate Surgical Risk

Results From The PARTNER 2 Trial

David J. Cohen, M.D., M.Sc.

On behalf of the PARTNER 2 Investigators

Saint Luke’s Mid-America Heart Institute University of Missouri-Kansas City Kansas City, Missouri

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The PARTNER 2 Trial was funded by a research grant from Edwards Lifesciences, Inc.

Disclosure

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Background

  • Improved quality of life (QOL) is a key goal of treatment for

patients with severe AS and may be even more important than improved survival for many elderly patients

  • Prior studies have shown that transcatheter aortic valve

replacement (TAVR) results in substantial and durable QOL benefits in extreme risk/inoperable patients and an early QOL benefit compared with surgical aortic valve replacement (SAVR) in patients at high surgical risk

  • However, the early QOL benefit of TAVR was confined to

patients who were suitable for transfemoral access and was not seen in patients treated via the transapical approach

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Background- 2

  • In the PARTNER 2A trial, TAVR was found to be non-

inferior to SAVR for the primary endpoint of 2-year death or disabling stroke among patients at intermediate surgical risk

  • There were differences in procedure-related complications

and valve performance at 1 year, however, with some endpoints favoring TAVR and others favoring surgical AVR

  • The overall impact of these alternative treatments on

health-related QOL from the patient’s perspective has not yet been reported

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Study Objectives

  • 1. To compare health-related quality of life outcomes

among patients with severe AS and intermediate surgical risk treated with either TAVR or SAVR

  • 2. To determine whether the QOL benefits of TAVR vs.

SAVR vary over time

  • 3. To examine whether the QOL benefits of TAVR vs.

SAVR in the intermediate risk population differ according to access site or other patient characteristics

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QOL assessed from all patients using validated questionnaires at baseline, 1 month, 1 year, and 2 years Symptomatic Severe Aortic Stenosis at Intermediate Surgical Risk (>4%) based on Heart Team Assessment

The PARTNER 2A Trial

QOL Study Design

VS.

Transapical (TA) / TransAortic (TAo)

1:1 Randomization (n=482)

TA/TAo TAVR (n=236) Surgical AVR (n=246)

No ASSESSMENT: Transfemoral Access

TF TAVR (n=775) Surgical AVR (n=775)

VS.

Transfemoral (TF)

1:1 Randomization (n=1550) Yes

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Methods: Quality of Life

Instrument Description/Role Kansas City Cardiomyopathy Questionnaire (KCCQ)

  • Heart Failure-specific QOL
  • Domains: Symptoms, Physical

Limitations, Quality of Life, Social Limitations

  • Scores: 0-100 (higher = better)

SF-36

  • General physical and mental health
  • Scores standardized such that mean=50,

standard deviation=10 (higher = better) EQ-5D (EuroQOL)

  • Generic instrument for assessment of

utilities and QALYs

  • Scores: 0-1 (0=death; 1=perfect health)
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Statistical Methods

  • Study Population: All patients with baseline QOL data

(n=1833, 90.2%) analyzed by ITT

  • Primary QOL Endpoint = KCCQ Overall Summary Score

̶ All other QOL scales considered secondary endpoints

  • Scores between groups compared using analysis of

covariance (ANCOVA), adjusting for baseline health status and access site

  • Analytic plan specified that separate analyses would be

performed for the transfemoral (TF) and transthoracic (TT) groups in case of a significant interaction between treatment effect and access site

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Baseline Characteristics

TAVR (n = 950) AVR (n = 883) Age (yrs) 81  7 81  7 Male gender 54.4% 55.4% STS risk score 5.8  2.1 5.8  1.8 Prior MI 18.1% 17.9% Prior CABG 23.7% 25.6% Prior Stroke 10.2% 10.2% COPD (O2 dependent) 11.2% 9.7% Mean AVG (mmHg) 45  13 45  12

P = NS for all comparisons

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Baseline Characteristics- QOL

TAVR (n = 950) AVR (n = 883) KCCQ Overall Summary 53.2  21.8 52.9  21.3 75-100 (~NYHA I) 18.4% 16.9% 60-74 (~NYHA II) 21.4% 22.9% 45-59 (~NYHA III) 23.5% 23.1% 0-45 (~NYHA IV) 36.7% 37.0% SF-12 Physical 36.1  8.9 35.9  8.7 SF-12 Mental 48.7  11.3 47.7  11.7

P = NS for all comparisons

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Primary Endpoint

KCCQ Overall Summary

30 50 70 90

  • 4

4 8 12 16 20 24 28

MCID = 5 points

D = 11.4 P < 0.001 D = -0.4 P = NS D = 0.5 P = NS

ANCOVA analysis; adjusted for baseline MCID = minimum clinically important difference

TAVR SAVR

2 year D = 19 points

Significant interaction (P<0.001) between treatment effect and access site for the primary endpoint and multiple secondary endpoints

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KCCQ Overall Summary (Primary Endpoint)

TF Subgroup

P-values are for mean treatment effect of TAVR vs. SAVR

D = 9.9 P<0.001 D = -0.5 P=NS D = -1.2 P=NS Treatment Difference (TAVR - AVR)

  • 20
  • 15
  • 10
  • 5

5 10 15 20 1 month 12 months 24 months

D = 14.1 P<0.001 D = -0.1 P=NS D = 1.0 P=NS

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KCCQ Overall Summary (Primary Endpoint)

TT Subgroup

P-values are for mean treatment effect of TAVR vs. SAVR

D = 3.5 P=NS D = -0.5 P=NS D = -1.2 P=NS Treatment Difference (TAVR -AVR)

  • 20
  • 15
  • 10
  • 5

5 10 15 20 1 month 12 months 24 months

D = 3.5 P=NS D = -0.5 P=NS D = -1.2 P=NS

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Treatment Difference (TAVR - AVR)

  • 10.0
  • 7.5
  • 5.0
  • 2.5

0.0 2.5 5.0 7.5 10.0 1 month 12 months 24 months

Generic QOL and Utilities

TF Subgroup

SF-36 Physical SF-36 Mental EQ-5D Utilities

D = 4.6 P <0.001 D = -0.8 P = NS D = 0.1 P = NS D = 5.4 P < 0.001 D = 1.2 P = NS D = 0.4 P = NS

Treatment Difference (TAVR - AVR)

  • 10.0
  • 7.5
  • 5.0
  • 2.5

0.0 2.5 5.0 7.5 10.0 1 month 12 months 24 months

D = 5.5 P <0.001 D =0.6 P = NS D = -0.1 P = NS

Treatment Difference (TAVR - AVR)

  • 0.20
  • 0.15
  • 0.10
  • 0.05

0.00 0.05 0.10 0.15 0.20 1 month 12 months 24 months

D = 0.066 P <0.001 D = -0.011 P = NS D = -0.002 P = NS

P-values are for mean treatment effect of TAVR vs. SAVR

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Generic QOL and Utilities

TT Subgroup

SF-36 Physical SF-36 Mental EQ-5D Utilities

Treatment Difference (TAVR -AVR)

  • 10.0
  • 7.5
  • 5.0
  • 2.5

0.0 2.5 5.0 7.5 10.0 1 month 12 months 24 months

Treatment Difference (TAVR -AVR)

  • 10.0
  • 7.5
  • 5.0
  • 2.5

0.0 2.5 5.0 7.5 10.0 1 month 12 months 24 months

Treatment Difference (TAVR -AVR)

  • 0.20
  • 0.15
  • 0.10
  • 0.05

0.00 0.05 0.10 0.15 0.20 1 month 12 months 24 months

D = 0.6 P = NS D = -0.1 P = NS D = 0.3 P = NS D = -0.1 P = NS D = 0.0 P = NS D = -.04 P = NS D =0.007 P = NS D = 0.000 P = NS D = 0.018 P = NS

P-values are for mean treatment effect of TAVR vs. SAVR

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KCCQ-Summary: Moderate or Substantial Improvement*: TF Subgroup

* Improvement ≥ 10 points vs. baseline among patients with available QOL data

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KCCQ-Summary: Moderate or Substantial Improvement*: TT Subgroup

* Improvement ≥ 10 points vs. baseline among patients with available QOL data

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Overall Clinical Status

TF Cohort

*P-values from ordinal logistic regression

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Overall Clinical Status

TT Cohort

*P-values from ordinal logistic regression

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TT vs. TF: Indirect Comparison

KCCQ Summary Scale

Non-randomized comparison

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Summary-1

  • Among patients with severe AS who were at

intermediate risk for surgical valve replacement, both surgical and transcatheter AVR resulted in substantial improvement in disease-specific and generic HRQOL over 2 year follow-up

– KCCQ Summary Scale ~ 20 points (MCID = 5) – SF-36 Physical ~ 4 points (MCID = 2) – SF-36 Mental ~ 3 points (MCID = 2)

  • Although the extent of improvement at 2 years was

similar with TAVR and SAVR, there were important differences in the rate and extent of recovery at the earlier time points

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Summary-2

  • For patients eligible for a TF approach, TAVR resulted in

substantial QOL benefits compared with SAVR at 1 month with similar QOL at later time points

  • For patients eligible only for a transthoracic approach (i.e.,

transapical or transaortic), there was no benefit of TAVR

  • ver SAVR at any time point
  • When both mortality and the extent of quality of life

improvement were evaluated together, TF-TAVR was superior to SAVR at all follow-up timepoints

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Conclusions

  • Taken together with previous data, these findings

demonstrate that for intermediate risk patients suitable for a TF approach, TAVR provides both early and late benefits compared with surgical AVR from the patient’s perspective

  • The lack of benefit among patients ineligible for the TF

approach suggests that a TT approach may not be preferable to SAVR in such patients– at least in the short to intermediate term

  • Further studies will be necessary to determine whether use
  • f other alternative access sites (e.g., subclavian, carotid,

transcaval) can overcome these limitations of the TT approach

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Thank You

MAHI Health Economics and Technology Assessment

  • Suzanne J. Baron, MD, MSc

Elizabeth A. Magnuson, Sc.D.

  • Kaijun Wang, Ph.D.

Suzanne Arnold, MD, MHA

  • Khaja Chinnakondepalli, MS

PARTNER Investigators and Publications Office

  • Maria Alu, MS
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