PARTNER 2 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 2 Trial On the Web |
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American Roentgen Ray Society Images of PARTNER 2 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 replacement (TAVR) versus surgical valve replacement among intermediate-risk patients with severe aortic stenosis
Methods
The Placement of Aortic Transcatheter Valves (PARTNER) 2 trial was a prospective, multicenter, randomized, active-treatment-controlled clinical trial comparing transcatheter aortic-valve replacement with surgical aortic valve replacement in intermediate-risk patients with severe aortic stenosis.
Intermediate-risk patient: defined by a Society of Thoracic Surgeons (STS) risk score of at least 4/0%; the upper limit applied by the care review committee was 8.0% (not prespecified). Patients with a score of less than 4.0% were enrolled if they had coexisting conditions that were not included in the risk model.
Patients were randomly assigned to two groups:
- Surgical aortic valve replacement
- Transcatheter aortic valve implantation (either a transfemoral or a transthoracic approach)
Study device: The balloon-expandable SAPIEN XT heart-valve system (Edwards Lifesciences)
The primary endpoint: The primary endpoint was a non hierarchical composite of death from any cause or disabling stroke at 2 years
Results
A total of 2034 intermediate-risk patients were enrolled at 57 centers. There was no significant difference in the rate of death from any cause or disabling stroke at 2 years between two groups (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of mortality or disabling stroke (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), while in the transthoracic-access cohort, the outcomes were comparable in both groups. TAVR was associated with lower rates of acute kidney injury (1.3% vs. 3.1%, P=0.006), life-threatening bleeding (10.4% vs. 43.4%, P<0.001), and new-onset atrial fibrillation (9.1% vs. 26.4%, P<0.001). At 30 days, Surgery was associated with fewer major vascular complications (5.0% vs.7.9, P=0.008) and less paravalvular aortic regurgitation. Patients in the TAVR group had fewer cardiac symptoms at 30 days compared with the surgery group (P=0.001), but the difference was insignificant at subsequent times. TAVR was associated with a significantly shorter duration of intensive care unit (ICU) stay (median, 2 vs. 4 days; P<0.001), as well as a shorter index hospitalization (median, 6 vs. 9 days; P<0.001).
Conclusion
In intermediate-risk patients with severe aortic stenosis, TAVR and surgical aortic-valve replacement were associated with similar rates of death or disabling stroke (non-inferiority of the transcatheter group, as compared with the surgical group).[1]
References
- ↑ Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG (April 2016). "Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients". N. Engl. J. Med. 374 (17): 1609–20. doi:10.1056/NEJMoa1514616. PMID 27040324.