PARTNER (Cohort A) Trial
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Aortic Stenosis Microchapters |
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Diagnosis |
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Treatment |
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Percutaneous Aortic Balloon Valvotomy (PABV) or Aortic Valvuloplasty |
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Transcatheter Aortic Valve Replacement (TAVR) |
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Case Studies |
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PARTNER (Cohort A) Trial On the Web |
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American Roentgen Ray Society Images of PARTNER (Cohort A) Trial |
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Risk calculators and risk factors for PARTNER (Cohort A) Trial |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mandana Chitsazan, M.D. [2]
Objective
To compare the outcomes with transcatheter aortic valve implantation (TAVI) versus surgical valve replacement among high-risk patients with severe symptomatic aortic stenosis
Methods
The Placement of Aortic Transcatheter Valves (PARTNER) trial Cohort A was a prospective, multicenter, randomized, active-treatment-controlled clinical trial comparing transcatheter aortic-valve replacement with surgical aortic valve replacement in high-risk patients with severe aortic stenosis.
High-risk patient: defined by a Society of Thoracic Surgeons (STS) risk score of 10% or higher or by the presence of coexisting conditions that would be associated with a predicted risk of death by 30 days after surgery of 15% or higher.
Patients were randomly assigned to two groups:
- Surgical aortic valve replacement
- Transcatheter aortic valve implantation (either a transfemoral or a transapical approach)
Study device: The Edwards SAPIEN heart-valve system (Edwards Lifesciences)
The primary endpoint: the rate of death from any cause at 1 year
Results
A total of 699 patients were enrolled at 25 centers. At 30 days, the rates of death from any cause were 3.4% in the transcatheter group compared with 6.5% in the surgical group (P=0.07). At 1 year, the rates of death from any cause were 24.2% in the transcatheter group compared with 26.8% in the surgical group (P=0.44), a reduction of 2.6 percentage point in the transcatheter group (two-sided 95% confidence interval [CI], -9.3 to 4.1; upper limit of the one-sided 95% CI, 3.0 percentage points) was within the prespecified noninferiority margin of 7.5 percentage points (P=0.001 for noninferiority). Rates of all neurologic events (i.e., all strokes and transient ischemic attacks) were higher in the transcatheter group than in the surgical group at 30 days (5.5% vs. 2.4%, P=0.04) and at 1 year (8.3% vs. 4.3%, P=0.04). At 30 days, the rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group P=0.20) At 1 year, the rates of major strokes were 5.1% in the transcatheter group and 2.4% in the surgical group (P=0.07). At 30 days, the transcatheter group had a significantly higher rate of major vascular complications than did the surgical group (11.0% vs. 3.2%, P<0.001) but had lower rates of major bleeding events (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%), P=0.006). At 30 days, more patients in the transcatheter group had an improvement in cardiac symptoms, but at 1 year there was no significant difference between the two groups.
Conclusion
In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic valve replacement were associated with similar rates of survival at 1 year and resulted in similar improvements in cardiac symptoms (noninferiority of the transcatheter group, as compared with the surgical group).[1]
References
- ↑ Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG; et al. (2011). "Transcatheter versus surgical aortic-valve replacement in high-risk patients". N Engl J Med. 364 (23): 2187–98. doi:10.1056/NEJMoa1103510. PMID 21639811.