Inoperable Trial

PARTNER 1B Trial - TAVI shows superior outcomes compared to standard therapy^1-3

A large, multicentre trial enrolling inoperable severe aortic stenosis (sAS) patients randomised to TAVI or standard therapy
The rate of death from any cause (primary endpoint) was superior with TAVI than with standard therapy at 1 year and at 5 years
TAVI significantly improved KCCQ overall summary score from baseline at 1 month, 6 months and 12 months in inoperable patients receiving TAVI

Inclusion and exclusion criteria

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)
Inoperability (risk of death or irreversible severe morbidity of at least 15% according to the assessment of a Heart Team consisting of one cardiologist and two cardiac surgeons)

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 standard therapy groups were generally well balanced. The exceptions were a lower percentage of patients with COPD and atrial fibrillation in the TAVI group compared to the standard therapy group (41.3% vs 52.5%, p=0.04 and 32.9% vs 48.8%, p=0.04, respectively). The overall patient population was at high risk.1*

TAVI (n=179)

Standard Therapy (n=179)

Age

83.1 ± 8.6

83.2 ± 8.3

Male

45.8%

46.9%

STS score^†

11.2 ± 5.8

12.1 ± 6.1

NYHA (III or IV)

92.2%

93.9%

Coronary artery disease

67.6%

74.3%

Peripheral vascular disease

30.3%

25.1%

COPD

41.3%

52.5%

Pulmonary hypertension

42.4%

43.8%

Creatinine > 2 mg/dL^‡

5.6%

9.6%

Frailty

18.1%

28.0%

Atrial fibrillation

32.9%

48.8%

Permanent pacemaker

22.9%

19.5%

Liver disease

3.4%

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

Secondary endpoint^1-3

Primary endpoint

Secondary endpoint^1-3

Quality of life

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

TAVI also resulted in significant improvements in health-related quality of life, compared with standard therapy, that was maintained for at least 1 year.³

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 1B Trial characteristics?

For inoperable patients with sAS, TAVI offered significantly improved survival and a more effective reduction of symptoms compared with standard therapy. In this severely ill patient group, a survival benefit was still evident even after five years^1,2
Despite multiple comorbidities and advanced age, patients similar to those enrolled in the PARTNER Trial could expect meaningful improvements in symptoms, functional status, and quality of life after TAVI³

PARTNER 1B Trial clinical paper

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References

1Leon MB, et al. N Engl J Med 2010;363:1597-1607 and supplementary material.
2 Kapadia SR, et al. Lancet 2015;385:2485-2491.
3 Reynolds MR, et al. Circulation. 2011;124:1964-1972.

Inoperable Trial

PARTNER 1B Trial - TAVI shows superior outcomes compared to standard therapy^1-3

Study design

The PARTNER 1B Trial study design¹

Inclusion and exclusion criteria

Baseline characteristics

Reported clinical and patient outcomes

Primary endpoint with added 5-year follow-up data

Quality of life

Clinical implications

Stay informed with our newsletter

References

Help us create better content with 3 short questions.

Inoperable Trial

PARTNER 1B Trial - TAVI shows superior outcomes compared to standard therapy1-3

Study design

The PARTNER 1B Trial study design1

Inclusion and exclusion criteria

Baseline characteristics

Reported clinical and patient outcomes

Primary endpoint with added 5-year follow-up data

Quality of life

Clinical implications

Related resources

Stay informed with our newsletter

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References

Help us create better content with 3 short questions.

PARTNER 1B Trial - TAVI shows superior outcomes compared to standard therapy^1-3

The PARTNER 1B Trial study design¹