Généreux Philippe, Schwartz Allan, Oldemeyer J Bradley, Pibarot Philippe, Cohen David J, Blanke Philipp, Lindman Brian R, Babaliaros Vasilis, Fearon William F, Daniels David V, Chhatriwalla Adnan K, Kavinsky Clifford, Gada Hemal, Shah Pinak, Szerlip Molly, Dahle Thom, Goel Kashish, O'Neill William, Sheth Tej, Davidson Charles J, Makkar Raj R, Prince Heather, Zhao Yanglu, Hahn Rebecca T, Leipsic Jonathon, Redfors Björn, Pocock Stuart J, Mack Michael, Leon Martin B
From Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.); Columbia University Medical Center/New York Presbyterian Hospital (A.S., R.T.H., M.B.L.), the Cardiovascular Research Foundation (D.J.C., R.T.H., B.R., M.B.L.), and Weill Cornell Medicine (B.R.), New York, and St. Francis Hospital and Heart Center, Roslyn (D.J.C.) - all in New York; University of Colorado Health, Medical Center of the Rockies, Loveland (J.B.O.); Laval University, Quebec, QC (P.P.), St. Paul's Hospital, University of British Columbia, Vancouver (P.B., J.L.), and McMaster University, Hamilton, ON (T.S.) - all in Canada; Vanderbilt University Medical Center, Nashville (B.R.L., K.G.); Emory University, Atlanta (V.B.); the Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University, Stanford (W.F.F.), VA Palo Alto Health Care System, Palo Alto (W.F.F.), California Pacific Medical Center, San Francisco (D.V.D.), Cedars-Sinai Medical Center, Los Angeles (R.R.M.), and Edwards Lifesciences, Irvine (H.P., Y.Z.) - all in California; Saint Luke's Mid America Heart Institute, Kansas City, MO (A.K.C.); Beth Israel Deaconess Medical Center/Harvard Medical School (C.K.) and Brigham and Women's Hospital (P.S.) - both in Boston; Pinnacle Health Harrisburg, Harrisburg, PA (H.G.); Baylor Scott and White The Heart Hospital Plano, Plano, TX (M.S., M.M.); CentraCare Heart and Vascular Center, St. Cloud, MN (T.D.); Henry Ford Hospital, Detroit (W.O.); Northwestern University, Chicago (C.J.D.); Gothenburg University/Sahlgrenska University Hospital, Gothenburg, Sweden (B.R.); and London School of Hygiene and Tropical Medicine, London (S.J.P.).
N Engl J Med. 2025 Jan 16;392(3):217-227. doi: 10.1056/NEJMoa2405880. Epub 2024 Oct 28.
For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking.
At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population.
A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement.
Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).
对于无症状的重度主动脉瓣狭窄且左心室射血分数保留的患者，当前指南建议每6至12个月进行常规临床监测。缺乏关于经导管主动脉瓣置换术（TAVR）早期干预是否会改善这些患者预后的随机试验数据。
在美国和加拿大的75个中心，我们以1:1的比例将无症状重度主动脉瓣狭窄患者随机分配接受经股动脉置入球囊扩张瓣膜的早期TAVR或临床监测。主要终点是死亡、中风或因心血管原因的非计划住院的复合终点。在意向性治疗人群中进行优效性检验。
共有901例患者进行了随机分组；455例患者被分配接受TAVR，446例患者被分配接受临床监测。患者的平均年龄为75.8岁，胸外科医师协会预测死亡率评分的平均值为1.8%（范围为0至100%，评分越高表明术后30天内死亡风险越大），83.6%的患者手术风险较低。TAVR组有122例患者（26.8%）发生主要终点事件，临床监测组有202例患者（45.3%）发生主要终点事件（风险比，0.50；95%置信区间，0.40至0.63；P<0.001）。接受TAVR的患者中有8.4%死亡，接受临床监测的患者中有9.2%死亡，中风发生率分别为4.2%和6.7%，因心血管原因的非计划住院发生率分别为20.9%和41.7%。在中位随访3.8年期间，临床监测组87.0%的患者接受了主动脉瓣置换。TAVR组患者与接受主动脉瓣置换的临床监测组患者之间在手术相关不良事件方面无明显差异。
在无症状重度主动脉瓣狭窄患者中，早期TAVR策略在降低死亡、中风或因心血管原因的非计划住院发生率方面优于临床监测。（由爱德华兹生命科学公司资助；EARLY TAVR临床试验注册号，NCT03042104。）
