Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy

Samir R Kapadia; E Murat Tuzcu; Raj R Makkar; Lars G Svensson; Shikhar Agarwal; Susheel Kodali; Gregory P Fontana; John G Webb; Michael Mack; Vinod H Thourani; Vasilis C Babaliaros; Howard C Herrmann; Wilson Szeto; Augusto D Pichard; Mathew R Williams; William N Anderson; Jodi J Akin; D Craig Miller; Craig R Smith; Martin B Leon

doi:10.1161/CIRCULATIONAHA.114.009834

Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy

Circulation. 2014 Oct 21;130(17):1483-92. doi: 10.1161/CIRCULATIONAHA.114.009834. Epub 2014 Sep 9.

Authors

Samir R Kapadia¹, E Murat Tuzcu², Raj R Makkar², Lars G Svensson², Shikhar Agarwal², Susheel Kodali², Gregory P Fontana², John G Webb², Michael Mack², Vinod H Thourani², Vasilis C Babaliaros², Howard C Herrmann², Wilson Szeto², Augusto D Pichard², Mathew R Williams², William N Anderson², Jodi J Akin², D Craig Miller², Craig R Smith², Martin B Leon²

Affiliations

¹ From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.). kapadis@ccf.org.
² From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).

PMID: 25205802
DOI: 10.1161/CIRCULATIONAHA.114.009834

Abstract

Background: The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown.

Methods and results: In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively (P<0.001; hazard ratio, 0.53; 95% confidence interval, 0.41-0.68; P<0.001). In survivors, there was significant improvement in New York Heart Association functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients versus 5.5% in patients undergoing standard therapy (hazard ratio, 2.81; 95% confidence interval, 1.26-6.26; P=0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P<0.001; hazard ratio, 0.60; 95% confidence interval, 0.46-0.77; P<0.001). Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomly assigned patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial.

Conclusions: TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection.

Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Keywords: aortic valve; aortic valve stenosis; outcome assessment (health care).

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aortic Valve Insufficiency / mortality
Aortic Valve Insufficiency / therapy
Aortic Valve Stenosis / mortality*
Aortic Valve Stenosis / therapy*
Cardiac Catheterization
Female
Follow-Up Studies
Hemodynamics
Hemorrhage / etiology
Hemorrhage / mortality
Humans
Kaplan-Meier Estimate
Male
Outcome Assessment, Health Care
Patient Readmission / statistics & numerical data
Proportional Hazards Models
Stroke / etiology
Stroke / mortality
Transcatheter Aortic Valve Replacement / adverse effects
Transcatheter Aortic Valve Replacement / methods*
Transcatheter Aortic Valve Replacement / mortality*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT00530894