From Cedars-Sinai Medical Center, Los Angeles (R.R.M., S.-H.Y., A.T.), Stanford University, Stanford (D.C.M., W.F.F.), and Edwards Lifesciences, Irvine (E.R., K.X., J.W.) - all in California; the Department of Cardiovascular Surgery, Piedmont Heart Institute (V.H.T.), and Emory University (V.B.) - both in Atlanta; Baylor Scott and White Healthcare, Plano (M.J.M., D.L.B.), and Medical City Dallas Hospital, Dallas (T.M.D.) - both in Texas; Columbia University Medical Center/New York-Presbyterian Hospital (S.K.K., R.T.H., M.C.A., C.R.S., M.B.L.) and NYU Langone Medical Center (M.R.W.) - both in New York; Cleveland Clinic, Cleveland (S.K., L.G.S., W.A.J.); St. Paul's Hospital, Vancouver, BC (J.G.W.), and Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Quebec, QC (P.P.) - both in Canada; University of Pennsylvania, Philadelphia (H.C.H., W.Y.S.); Medstar Washington Hospital Center, Washington, DC (L.S.); University of Missouri-Kansas City School of Medicine, Kansas City (D.J.C.); Christ Hospital, Cincinnati (D.J.K.); Barnes-Jewish Hospital, Washington University, St. Louis (A.Z.); Mayo Clinic, Rochester, MN (K.L.G.); Intermountain Medical Center, Salt Lake City (B.K.W.); Providence St. Vincent Medical Center, Portland, OR (R.W.H.); and Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (M.J.R.).
N Engl J Med. 2020 Jan 29;382(9):799-809. doi: 10.1056/NEJMoa1910555. Print 2020 Feb 27.
There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.
We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.
At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.
Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
对于中危主动脉瓣狭窄患者，经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术相比，长期临床结局和生物瓣功能的数据较为匮乏。
我们在 57 个中心纳入了 2032 例严重、有症状的主动脉瓣狭窄中危患者。根据预期经股或经胸入路对患者进行分层（分别为 76.3%和 23.7%），并随机分配接受 TAVR 或外科置换。对 5 年的临床、超声心动图和健康状况结局进行随访。主要终点是任何原因导致的死亡或致残性卒中。
5 年时，TAVR 组和外科组的任何原因导致的死亡或致残性卒中发生率无显著差异（分别为 47.9%和 43.4%；风险比为 1.09；95%置信区间[CI]为 0.95 至 1.25；P=0.21）。经股入路队列的结果相似（分别为 44.5%和 42.0%；风险比为 1.02；95%CI 为 0.87 至 1.20），但经胸入路队列中 TAVR 后的死亡或致残性卒中发生率高于外科（59.3% vs. 48.3%；风险比为 1.32；95%CI 为 1.02 至 1.71）。5 年时，TAVR 组中至少有轻度瓣周主动脉反流的患者多于外科组（33.3% vs. 6.3%）。TAVR 后重复住院的频率高于外科（33.3% vs. 25.2%），主动脉瓣再介入的频率也高于外科（3.2% vs. 0.8%）。TAVR 和外科在 5 年时的健康状况改善相似。
在中危主动脉瓣狭窄患者中，TAVR 与外科主动脉瓣置换术相比，5 年时的死亡或致残性卒中发生率无显著差异。（由爱德华兹生命科学公司资助；PARTNER 2 临床试验.gov 编号，NCT01314313。）
