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Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients
Michael J Mack1, Martin B Leon1, Vinod H Thourani1
1From Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York-Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) - both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars-Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) - both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul's Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) - both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) - both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Background:
Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk.
Methods:
We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.
Results:
At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation.
Conclusions:
Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
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