PARTNER 2
Trial question
Is TAVR noninferior to SAVR in intermediate-risk patients with severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 2032
2032 patients (924 female, 1108 male).
Inclusion criteria: intermediate risk patients with severe aortic stenosis.
Key exclusion criteria: heart team assessment of inoperability, evidence of acute MI ≤ 1 month, congenital unicuspid or bicuspid aortic valve, mixed aortic valve disease, preexisting mechanical or bioprosthetic valve, complex coronary artery disease, HCM with or without obstruction, leukopenia, acute anemia, severe ventricular dysfunction.
Interventions
N=1011 TAVR (transfemoral or transthoracic placement of SAPIEN XT valve system).
N=1021 surgery (surgical aortic-valve replacement).
Primary outcome
All-cause mortality or disabling stroke at 2 years
19.3%
21.1%
21.1 %
15.8 %
10.6 %
5.3 %
0.0 %
Transcatheter aortic valve
replacement
Surgery
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in all-cause mortality or disabling stroke at 2 years (19.3% vs. 21.1%; HR 0.89, 95% CI 0.73 to 1.09).
Secondary outcomes
No significant difference in death from any cause at 2 years (16.7% vs. 18%; RR 0.93, 95% CI -1.44 to 3.3).
No significant difference in disabling stroke at 2 years (6.2% vs. 6.4%; RR 0.97, 95% CI -7.32 to 9.26).
No significant difference in rehospitalization at 2 years (19.6% vs. 17.3%; RR 1.13, 95% CI -0.67 to 2.93).
Safety outcomes
Significant differences in major vascular complications (7.9% vs. 5.0%), life-threatening bleeding (10.4% vs. 43.4%), AKI (1.3% vs. 3.1%), and new-onset AF (9.1% vs. 26.4%) at 30 days.
Conclusion
In intermediate risk patients with severe aortic stenosis, TAVR was noninferior to surgery with respect to all-cause mortality or disabling stroke at 2 years.
Reference
Leon MB, Smith CR, Mack MJ et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20.
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