Long-Term Outcomes of Inoperable Patients With Aortic Stenosis Randomly Assigned to Transcatheter Aortic Valve Replacement or Standard Therapy

被引:133
作者
Kapadia, Samir R. [1 ]
Tuzcu, E. Murat [1 ]
Makkar, Raj R. [2 ]
Svensson, Lars G. [1 ]
Agarwal, Shikhar [1 ]
Kodali, Susheel [3 ]
Fontana, Gregory P. [4 ]
Webb, John G. [5 ]
Mack, Michael [6 ]
Thourani, Vinod H. [7 ]
Babaliaros, Vasilis C. [7 ]
Herrmann, Howard C. [8 ]
Szeto, Wilson [8 ]
Pichard, Augusto D. [9 ]
Williams, Mathew R. [3 ]
Anderson, William N. [10 ]
Akin, Jodi J. [10 ]
Miller, D. Craig [11 ]
Smith, Craig R. [3 ]
Leon, Martin B. [3 ]
机构
[1] Cleveland Clin Fdn, Cleveland, OH 44195 USA
[2] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA
[3] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA
[4] Lenox Hill Hosp, New York, NY 10021 USA
[5] St Pauls Hosp, Vancouver, BC V6Z 1Y6, Canada
[6] Baylor Healthcare Syst, Plano, TX USA
[7] Emory Univ, Sch Med, Atlanta, GA USA
[8] Hosp Univ Penn, Philadelphia, PA 19104 USA
[9] Medstar Washington Hosp Ctr, Washington, DC USA
[10] Edwards Lifesci, Irvine, CA USA
[11] Stanford Univ, Stanford, CA 94305 USA
关键词
aortic valve; aortic valve stenosis; outcome assessment (health care); HIGH-RISK PATIENTS; IMPLANTATION; EXPERIENCE; PREDICTORS; REGISTRY; SURGERY; TAVI;
D O I
10.1161/CIRCULATIONAHA.114.009834
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1483 / U106
页数:13
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