美国洛杉矶雪松西奈山医疗中心Raj R. Makkar研究团队的一项最新研究比较了经导管或外科主动脉瓣置换手术的5年结局。相关论文发表在2020年1月29日出版的《新英格兰医学杂志》上。

对于严重主动脉狭窄和中等手术风险的患者，经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术相比，其远期临床疗效和生物瓣膜功能的数据很少。

研究组在57个中心招募了2032名有严重症状的主动脉狭窄中危患者，根据计划经股动脉或经胸入路（分别占76.3%和23.7%）对患者进行分层，并随机分组分别接受TAVR或外科主动脉瓣置换术。

随访5年后，TAVR组和手术组的全因死亡或致残性中风的发生率分别为47.9%和43.4%，差异不显著；经股动脉入路的患者中两组间发生率分别为44.5%和42.0%，差异不显著；经胸入路的患者中TAVR组发生率为59.3%，显著高于手术组（48.3%）。

TAVR组中有33.3%的患者发生至少轻度的主动脉瓣返流，显著高于手术组（6.3%）。TAVR组术后再住院率为33.3%，显著高于手术组（25.2%）。TAVR组术后主动脉瓣再通术的发生率为3.2%，显著高于手术组（0.8%）。TAVR组患者术后5年的健康状况改善程度与手术组相差不大。

总之，在主动脉瓣狭窄患者中，TAVR组术后5年死亡或致残性卒中的发生率，与主动脉瓣置换术相比，并无显著性差异。 

附：英文原文

Title: Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

Author: Raj R. Makkar, M.D.,, Vinod H. Thourani, M.D.,, Michael J. Mack, M.D.,, Susheel K. Kodali, M.D.,, Samir Kapadia, M.D.,, John G. Webb, M.D.,, Sung-Han Yoon, M.D.,, Alfredo Trento, M.D.,, Lars G. Svensson, M.D., Ph.D.,, Howard C. Herrmann, M.D.,, Wilson Y. Szeto, M.D.,, D. Craig Miller, M.D.,, Lowell Satler, M.D.,, David J. Cohen, M.D.,, Todd M. Dewey, M.D.,, Vasilis Babaliaros, M.D.,, Mathew R. Williams, M.D.,, Dean J. Kereiakes, M.D.,, Alan Zajarias, M.D.,, Kevin L. Greason, M.D.,, Brian K. Whisenant, M.D.,, Robert W. Hodson, M.D.,, David L. Brown, M.D.,, William F. Fearon, M.D.,, Mark J. Russo, M.D.,, Philippe Pibarot, D.V.M., Ph.D.,, Rebecca T. Hahn, M.D.,, Wael A. Jaber, M.D.,, Erin Rogers, M.Eng.,, Ke Xu, Ph.D.,, Jaime Wheeler, M.B.A., C.Ph.T.,, Maria C. Alu, M.S.,, Craig R. Smith, M.D.,, and Martin B. Leon, M.D.

Issue&Volume: 2020-01-29

Abstract:

Background

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.

Methods

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.

Results

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.

Conclusions

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.)

DOI: 10.1056/NEJMoa1910555

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1910555