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Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years
被引：176
作者：
Mack, Michael J.
[1
]
Leon, Martin B.
[2
,3
,13
]
Thourani, Vinod H.
[5
]
Pibarot, Philippe
[7
]
Hahn, Rebecca T.
[2
,3
]
Genereux, Philippe
[9
]
Kodali, Susheel K.
[2
,3
]
Kapadia, Samir R.
[11
]
Cohen, David J.
[3
,4
]
Pocock, Stuart J.
[12
]
Lu, Michael
White, Roseann
[13
]
Szerlip, Molly
[1
]
Ternacle, Julien
[15
]
Malaisrie, S. Chris
[16
]
Herrmann, Howard C.
[17
]
Szeto, Wilson Y.
[17
]
Russo, Mark J.
[10
]
Babaliaros, Vasilis
[6
]
Smith, Craig R.
[2
,3
]
Blanke, Philipp
[8
]
Webb, John G.
[8
]
Makkar, Raj
[14
]
机构：
[1] Baylor Scott & White Hlth, Plano, TX USA
[2] Columbia Univ, New York, NY USA
[3] Cardiovasc Res Fdn, New York, NY USA
[4] St Francis Hosp & Heart Ctr, Roslyn, NY USA
[5] Piedmont Heart Inst, Marcus Heart Valve Ctr, Atlanta, GA USA
[6] Emory Univ, Atlanta, GA USA
[7] Laval Univ, Quebec City, PQ, Canada
[8] Univ British Columbia, St Pauls Hosp, Vancouver, BC, Canada
[9] Morristown Med Ctr, Morristown, NJ USA
[10] Robert Wood Johnson Univ Hosp, New Brunswick, NJ USA
[11] Cleveland Clin, Cleveland, OH USA
[12] London Sch Hyg & Trop Med, London, England
[13] Edwards Lifesci, Irvine, CA USA
[14] Cedars Sinai Med Ctr, Los Angeles, CA USA
[15] Univ Bordeaux, Haut Leveque Hosp, Heart Valve Unit, Pessac, France
[16] Northwestern Univ, Chicago, IL USA
[17] Univ Penn, Philadelphia, PA USA
关键词：
CLINICAL-TRIALS;
END-POINTS;
OUTCOMES;
D O I：
10.1056/NEJMoa2307447
中图分类号：
R5 [内科学];
学科分类号：
1002 ;
100201 ;
摘要：
BackgroundA previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown.MethodsWe randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years.ResultsA total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P=0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P=0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (+/- SD) valve gradient, was 12.8 +/- 6.5 mm Hg in the TAVR group and 11.7 +/- 5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group.ConclusionsAmong low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.) Among patients at low surgical risk who underwent TAVR or surgery, there was no apparent difference between groups in the incidence of the composite end point of death, stroke, or rehospitalization at 5 years.
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页码：1949 / 1960
页数：12
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