High Risk Trial

PARTNER 1A Trial - TAVI shows similar outcomes compared to sAVR1-3

  • A large, multicentre trial enrolling high-risk severe aortic stenosis (sAS) patients randomised to either TAVI or sAVR
  • The rate of death (primary endpoint) was non-inferior with TAVI and sAVR at 1 year
  • TAVI significantly improved KCCQ overall summary score from baseline at 1 month, 6 months and 12 months in patients receiving transfemoral TAVI

The PARTNER 1A Trial study design1

Inclusions1

  • Severe aortic valve stenosis (aortic valve area <0.8 cm2 or mean gradient >40 mm Hg or peak velocity >4.0 m/s)
  • Cardiac symptoms (NYHA class ≥II)
  • High surgical risk (risk of death or irreversible severe morbidity at least 15% according to the assessment of a heart team of cardiologists and cardiac surgeons – STS score ≥10)

Exclusions1

  • Evidence of an acute myocardial infarction ≤1 month before the intended treatment
  • Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
  • Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation)
  • Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency

The baseline characteristics of the patients in the TAVI and sAVR groups were generally well balanced1*

    TAVI (n=348)
    Surgery (n=351)
Age
83.6 ± 6.8
84.5 ± 6.4
Male
57.8%
56.7%
STS score†
11.8 ± 3.3
11.7 ± 3.5
NYHA (III or IV)
94.3%
94.0%
Coronary artery disease
74.9%
76.9%
Peripheral vascular disease
43.0%
41.6%
COPD
43.4%
43.0%
Pulmonary hypertension
42.4%
36.4%
Creatinine > 2 mg/dL‡
11.1%
7.0%
Frailty
15.6%
17.6%
Atrial fibrillation
40.8%
42.7%
Permanent pacemaker
20%
21.9%
Liver disease
2.0%
2.6%

* Plus–minus values are means ±SD.

† 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%.

‡ To convert values for creatinine to micromoles per litre, multiply by 88.4.

Reported clinical and patient outcomes

Primary endpoint with added 5-year follow-up data

At 1 year:1

  • All-cause mortality occurred in 84 patients (24.2%) in the TAVI group versus 89 patients (26.8%) in the sAVR group (p=0.44)

A 5 years:2

  • All-cause mortality occurred in 67.8% of patients in the TAVI group versus 62.4% of patients in the sAVR group (p=0.76)

TAVI versus surgery in high-risk patients2

30 days
TAVI
sAVR
1 year
TAVI
sAVR
5 years*
TAVI
sAVR
Cardiovascular mortality
3.2%
3.0%
14.3%
13.0%
53.1%
47.6%
P-value
0.90
0.63
0.67
Stroke or TIA
5.5%
2.4%
8.3%
4.3%
15.9%
14.7%
P-value
0.04
0.04
0.35
NYHA class I or II
72.8%
59.1%
64.5%
65.3%
85%
81%
P-value
< 0.001
0.74
0.57

* Prolonged follow-up

Quality of life

Patients receiving transfemoral TAVI enjoyed an improved health status at 1, 6 and 12 months after the procedure from baseline, as measured using the KCCQ (Kansas City Cardiomyopathy Questionnaire – Overall Summary).3

The rapid recovery from transfemoral TAVI was associated with short-term benefits in health status at 1 month. Based on the 6 and 12-month score difference, TAVI also provided meaningful, late health status benefits.3

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

Real-world data

Source 3 registry5-7

  • 1,950 sAS patients from 80 centres in 10 countries were enrolled between July 2014 and October 2015
  • Inclusion criteria included patients suffering from severe, symptomatic, calcific AS, STS Score ≥8 and a Logistic EuroSCORE ≥15
  • With TAVI, the rate of death at 30-days (primary endpoint) was low (2.2% overall, 1.9% transfemoral access vs 4.0% non-transfemoral access, p=0.0023)

Clinical implications

What could a TAVI referral mean for your patients who match the PARTNER 1A trial characteristics?

  • For high-risk patients with sAS, TAVI offered similar chances of survival compared with sAVR even after five years of follow-up1,2
  • This could mean the difference between a life well lived and a life of compromises3
PARTNER 1A trial clinical paper

Related resources

Edwards TAVI study compendium

In-depth summary of the key Edwards Lifescience TAVI studies.

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References:

1 Smith CR et al. N Engl J Med 2011;364:2187-2198 and supplementary material.
2 Mack MJ et al. Lancet 2015;385:2477-2484.
3 Reynolds MR et al. J Am Coll Cardiol 2012;60:548–558.
4 Edwards Lifesciences. Data on File.
5 Wendler O et al. Circulation 2017;135:1123-1132.
6 Wendler O et al. Eur Heart J 2017;38:2717-2726.
7 ClinicalTrials.gov. Identifier: NCT02698956. Available from https://clinicaltrials.gov/ct2/show/NCT02698956 (accessed September 2020).

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