无法手术的主动脉瓣狭窄患者随机分配至经导管主动脉瓣置换术或标准治疗的长期结果。
Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy.
机构信息
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.).
出版信息
Circulation. 2014 Oct 21;130(17):1483-92. doi: 10.1161/CIRCULATIONAHA.114.009834. Epub 2014 Sep 9.
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.
背景
经导管主动脉瓣置换术（TAVR）在无法手术的严重主动脉瓣狭窄患者中的长期结果尚不清楚。
方法和结果
在 Placement of Aortic Transcatheter Valves（PARTNER）研究中，358 名患者被随机分配至 TAVR 或标准治疗。我们报告了这些患者的 3 年结果，以及 PARTNER 中所有随机分配的无法手术患者（n=449）的汇总结果，包括继续准入研究的随机部分（n=91）。TAVR 组和标准治疗组的 3 年死亡率分别为 54.1%和 80.9%（P<0.001；风险比，0.53；95%置信区间，0.41-0.68；P<0.001）。在幸存者中，纽约心脏协会功能分级在 3 年时显著改善并得以维持。3 年随访时 TAVR 患者的卒中新发率为 15.7%，而标准治疗组为 5.5%（风险比，2.81；95%置信区间，1.26-6.26；P=0.012）；然而，TAVR 后死亡或卒中新发的复合终点显著低于标准治疗组（57.4%对 80.9%，P<0.001；风险比，0.60；95%置信区间，0.46-0.77；P<0.001）。超声心动图显示 TAVR 后主动脉瓣面积持续增加，跨瓣梯度降低。对 449 名随机分配患者（TAVR，n=220；标准治疗，n=229）的汇总分析显示，在早期和 3 年随访期间，全因死亡率和功能状态均显著改善。汇总队列的结果与主要的 PARTNER 试验结果相似。
结论
TAVR 可改善无法手术的严重主动脉瓣狭窄患者的生存率和功能状态，并在长期随访中带来持久的血流动力学获益。然而，即使在成功治疗的 TAVR 患者中，仍存在较高的残余死亡率，这突出了更具策略性的患者选择的必要性。
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