Inoperable Trial

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

Clinician-with-patient

The PARTNER 1B Trial study design1

PARTNER-1A-study-design

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%
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

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
Quality of Life - Inoperable patients

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

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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.

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