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TAVI.today

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Clinical evidence

Low Risk Trial

PARTNER 3 Trial - TAVI shows superior outcomes compared to sAVR1

  • A large prospective, multi-centre trial enrolling low surgical risk severe aortic stenosis (sAS) patients randomised to either TAVI or surgery (sAVR)
  • The rate of the composite of death, stroke, or rehospitalisation at 1 year (primary endpoint) was significantly lower with SAPIEN 3 TAVI than with sAVR
  • A number of prespecified secondary endpoints were also statistically significant in favour of TAVI
Clinician-with-patient

The PARTNER 3 Trial study design1

PARTNER-3-study-design

Inclusions1

  1. Severe, calcific aortic stenosis meeting the following criteria:
    • AVA  ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2 /m2
    • Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
    • a) NYHA Functional Class ≥ II OR
    • b) Exercise test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
    • c) Asymptomatic with LVEF <50%
  2. Low risk of operative mortality and an STS <4%
     

Exclusions1

  1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29mm THV based on 3D imaging analysis
  2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
  3. Patients with clinical frailty, bicuspid aortic valves, or other anatomical and clinical features that increased the risk of complications associated with either TAVI or sAVR were excluded

Baseline characteristics were well balanced in the two groups with the exception of a higher percentage of patients with an NYHA class of III or IV in the SAPIEN 3 TAVI group than in the sAVR group (31.2% vs. 23.8%, p<0.05).1*
TAVI (n=496)
Surgery (n=454)
Age
73.3 ± 5.8
73.6 ± 6.1
Male
67.5%
71.1%
BMI – kg / m2†
30.7 ± 5.5
30.3 ± 5.1
STS Score‡
1.9 ± 0.7
1.9 ± 0.6
NYHA (III or IV)
31.2%
23.8%
Coronary artery disease
27.7%
28.0%
Peripheral vascular disease
6.9%
7.3%
Diabetes
31.2%
30.2%
COPD
5.1%
6.2%
Pulmonary hypertension
4.6%
5.3%
Creatinine > 2 mg/dL§
0.2%
0.2%
Frailty (>2/4+)
0
0
Atrial fibrillation
15.7%
18.8%
Permanent pacemaker
2.4%
2.9%
Left bundle branch block
3.0%
3.3%
Right bundle branch block
10.3%
13.7%

Plus–minus values are means ±SD.The body-mass index is the weight in kilograms divided by the square of the height in metres.Scoring on the risk model of the Society of Thoracic Surgeons (STS) uses an algorithm that is based on the presence of coexisting illnesses in order to predict 30-day operative mortality. The STS score equals the predicted mortality expressed as a percentage. Less than 5% of patients in the population on which the STS algorithm is based had a predicted operative mortality (risk score) of more than 10%. Data on this score were missing for one patient. To convert values for creatinine to micromoles per litre, multiply by 88.4.

Reported clinical and patient outcomes

2-year follow-up

See below the 2-year data presented at the American Cardiology Congress (ACC)/World Congress of Cardiology, March 28-30, 2020, Chicago, IL. 

 

The prolonged follow-up, to 2 years, continues to show a statistical benefit in favour of SAPIEN 3 TAVI compared to sAVR.2

 

  • 17.4% vs 11.5% (absolute difference 5.9%; HR 0.63 [95% CI, 0.45 to 0.88]; p=0.007)

Quality of life

The TAVI group enjoyed a better health status at 1, 6 and 12 months after the procedure compared to the sAVR group, as measured using the KCCQ-OS (Kansas City Cardiomyopathy Questionnaire – Overall Summary)3

PARTNER-3-QoL-KCCQ-scores-infographic

Although the late health status benefits of TAVI are small, they are still important as they may represent a clinically meaningful improvement for a certain group of patients.3,4 

 

Find out more about the QoL analysis and see the full outcome data

Clinical implications

What could a TAVI referral mean for your patients who match the PARTNER 3 Trial characteristics?

  • Lowering your patients’ risk of death or disabling stroke at 1 year to just 1%1
  • A speedy recovery to help patients get back to the life they love1
  • Meaningful, early and late health status benefits which could give your patients the opportunity for a fuller life3, 4
PARTNER 3 Trial clinical paper

Related resources

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Edwards TAVI study compendium
In-depth summary of the key Edwards Lifescience TAVI studies.
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TAVI procedural animation
Transfemoral approach for TAVI using balloon-expandable technology. Available to order as USB.
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Tavi durability overview
TAVI durability overview
A summary of the current durability data (up to 8 years) for TAVI valves.
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References

  • 1Mack MJ, et al. N Engl J Med. 2019;380:1695–1705 and supplementary material.
  • 2 Mack MJ. Two-year clinical and echocardiographic outcomes from the PARTNER 3 low-risk randomized trial. Presented at: ACC 2020. March 29, 2020.
  • 3 Baron SJ, Magnuson EA, Lu M, et al. J Am Coll Cardiol 2019; 74(23):2833-2842.
  • 4 Baron SJ. Presentation at TCT, September 25–29, 2019; San Francisco, CA, USA.

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