PARTNER B
Trial question
What is the role of TAVI in patients with severe aortic stenosis who are not suitable candidates for surgical replacement of aortic valve?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 358
358 patients (192 female, 166 male)
Inclusion criteria: patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery
Key exclusion criteria: bicuspid or noncalcified aortic valve, acute myocardial infarction, substantial coronary artery disease requiring revascularization, a LVEF < 20%, severe mitral or aortic regurgitation, TIA or stroke within the previous 6 months, and severe renal insufficiency
Interventions
N=179 TAVR (transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve)
N=179 standard therapy (balloon aortic valvuloplasty plus adjunctive pharmacologic therapy)
Primary outcome
Death at 1 year
30.7
50.7
50.7 %
38.0 %
25.4 %
12.7 %
0.0 %
Transcatheter aortic valve
replacement
Standard
therapy
Significant
decrease ▼
NNT = 4
Significant decrease in death at 1 year (30.7% vs. 50.7%; HR 0.55, 95% CI 0.4 to 0.74)
Secondary outcomes
Significant decrease in death from any cause or repeat hospitalization (42.5% vs. 71.6%; HR 0.46, 95% CI 0.35 to 0.59)
Significant decrease in death from cardiovascular causes at 1 year (20.5% vs. 44.6%; HR 0.39, 95% CI 0.27 to 0.56)
Significant decrease in death from any cause or major stroke at 1 year (33% vs. 51.3%; HR 0.58, 95% CI 0.43 to 0.78)
Safety outcomes
Significant differences in major vascular complications (16.2% vs. 1.1%, p < 0.001).
Conclusion
In patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, TAVR was superior to standard therapy with respect to death at 1 year.
Reference
Leon MB, Smith CR, Mack M et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607.
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