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Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years
Michael J Mack1, Martin B Leon1, Vinod H Thourani1
1From Baylor Scott and White Health, Plano, TX (M.J.M., M.S.); Columbia University (M.B.L., R.T.H., S.H.K., C.R.S.) and the Cardiovascular Research Foundation (M.B.L., R.T.H., S.H.K., D.J.C., C.R.S.), New York, and St. Francis Hospital and Heart Center, Roslyn (D.J.C.) - all in New York; Marcus Heart Valve Center, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - both in Atlanta; Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (P.B., J.G.W.) - both in Canada; Morristown Medical Center, Morristown (P.G.), and Robert Wood Johnson University Hospital, New Brunswick (M.J.R.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); London School of Hygiene and Tropical Medicine, London (S.J.P.); Edwards Lifesciences, Irvine (M.L., R.W.), and Cedars-Sinai Medical Center, Los Angeles (R.M.) - both in California; Heart Valve Unit, Haut-Lévêque Cardiological Hospital, Bordeaux University, Pessac, France (J.T.); Northwestern University, Chicago (S.C.M.); and the University of Pennsylvania, Philadelphia (H.C.H., W.Y.S.).
Background:
A 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.
Methods:
We 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.
Results:
A 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.
Conclusions:
Among 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.).
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