Inoperable Trial
PARTNER 1B Trial - TAVI shows superior outcomes compared to standard therapy1-3
- 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
The PARTNER 1B Trial study design1
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)
- Síntomas cardíacos (clase NYHA ≥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
Baseline characteristics
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*
* 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
The rate of death was significantly lower with TAVI than with standard therapy at 1 year and 5 years1,2
At 1 year:1
- All-cause mortality occurred in 55 patients (30.7%) in the TAVI group versus 89 patients (50.7%) in the standard therapy group (absolute difference 20%, p<0.001)
- The composite endpoint of death or rehospitalisation occurred in 76 patients (42.5%) in the TAVI group versus 126 patients (70.4%) in the standard therapy group (p<0.001)
At 5 years:2
- All-cause mortality occurred in 71.8% of patients in the TAVI group versus 93.6% of patients in the standard therapy group (absolute difference 21.8%, p<0.0001)
* Prolonged follow-up
† Denotes values for stroke only in the inoperable group at 5 years.
‡ P-value is for TAVI versus sAVR/standard treatment for the full range of functional classes.
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 years1,2
- 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
Related resources
Edwards TAVI study compendium
In-depth summary of the key Edwards Lifescience TAVI studies.
PARTNER 3 Trial outcomes summary
Infographic comparing SAPIEN 3 TAVI with sAVR in patients with severe aortic stenosis at low surgical risk.
TAVI durability overview
A summary of the current durability data (up to 8 years) for TAVI valves.
References:
1 Leon 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.
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