Mortality in trials on transcatheter aortic valve implantation versus surgical aortic valve replacement: a pooled meta-analysis of Kaplan-Meier-derived individual patient data

被引：47

作者：

Barili, Fabio ^{[1
]}

Freemantle, Nicholas ^{[2
]}

Casado, Alberto Pilozzi ^{[1
]}

Rinaldi, Mauro ^{[3
]}

Folliguet, Thierry ^{[4
]}

Musumeci, Francesco ^{[5
,6
]}

Gerosa, Gino ^{[7
]}

Parolari, Alessandro ^{[8
]}

机构：

[1] S Croce Hosp, Dept Cardiac Surg, Via M Coppino 26, I-12100 Cuneo, Italy

[2] UCL, Dept Primary Care & Populat Hlth, London, England

[3] Univ Turin, Dept Cardiac Surg, AOU Citta Salute & Sci Torino, Turin, Italy

[4] Hop Henri Mondor, Dept Cardiac Surg, Paris, France

[5] S Camillo Forlanini Hosp, Cardiac Surg Unit, Dept Heart & Vessels, Rome, Italy

[6] S Camillo Forlanini Hosp, Heart Transplantat Ctr, Rome, Italy

[7] Univ Padua, Dept Cardiac Surg, Padua, Italy

[8] Univ Milan, Unit Cardiac Surg & Translat Res, IRCCS Policlin S Donato, Milan, Italy

来源：

EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY | 2020年 / 58卷 / 02期

关键词：

Aortic valve; Transcatheter aortic valve implantation; Surgical aortic valve replacement; RISK; OUTCOMES; STENOSIS; REGURGITATION; ASSOCIATION; GUIDELINES; DISEASE;

D O I：

10.1093/ejcts/ezaa087

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVES: This meta-analysis of Kaplan-Meier-estimated individual patient data was designed to evaluate the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on the long-term all-cause mortality rate, to examine the potential time-varying effect and to model their hazard ratios (HRs) over time. Moreover, we sought to compare traditional meta-analytic tools and estimated individual patient data meta-analyses. METHODS: Trials comparing TAVI versus SAVR were identified through Medline, Embase, Cochrane databases and specialist websites. The primary outcome was death from any cause at follow-up. Enhanced secondary analyses of survival curves were performed estimating individual patient time-to-event data from published Kaplan-Meier curves. Treatments were compared with the random effect Cox model in a landmark framework and fully parametric models. RESULTS: We identified 6 eligible trials that included 6367 participants, randomly assigned to undergo TAVI (3252) or SAVR (3115). According to the landmark analysis, the incidence of death in the first year after implantation was significantly lower in the TAVI group [risk-profile stratified HR 0.85, 95% confidence interval (CI) 0.73-0.99; P=0.04], whereas there was a reversal of the HR after 40months (risk-profile stratified HR 1.31, 95% CI 1.01-1.68; P=0.04) favouring SAVR over TAVI. This time-varying trend of HRs was also confirmed by a fully parametric time-to-event model. Traditional meta-analytic tools were shown to be biased because they did not intercept heterogeneity and the time-varying effect. CONCLUSIONS: The mortality rates in trials of TAVI versus SAVR are affected by treatments with a time-varying effect. TAVI is related to better survival in the first months after implantation whereas, after 40 months, it is a risk factor for all-cause mortality.

引用

页码：221 / 229

页数：9

共 26 条

[1] Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis [J].

Adams, David H. ;

Popma, Jeffrey J. ;

Reardon, Michael J. ;

Yakubov, Steven J. ;

Coselli, Joseph S. ;

Deeb, G. Michael ;

Gleason, Thomas G. ;

Buchbinder, Maurice ;

Hermiller, James, Jr. ;

Kleiman, Neal S. ;

Chetcuti, Stan ;

Heiser, John ;

Merhi, William ;

Zorn, George ;

Tadros, Peter ;

Robinson, Newell ;

Petrossian, George ;

Hughes, G. Chad ;

Harrison, J. Kevin ;

Conte, John ;

Maini, Brijeshwar ;

Mumtaz, Mubashir ;

Chenoweth, Sharla ;

Oh, Jae K. .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (19) :1790-1798

[2] Guidelines for reporting mortality and morbidity after cardiac valve interventions [J].

Akins, Cary W. ;

Miller, D. Craig ;

Turina, Marko I. ;

Kouchoukos, Nicholas T. ;

Blackstone, Eugene H. ;

Grunkemeier, Gary L. ;

Takkenberg, Johanna J. M. ;

David, Tirone E. ;

Butchart, Eric G. ;

Adams, David H. ;

Shahian, David M. ;

Hagl, Siegfried ;

Mayer, John E. ;

Lytle, Bruce W. .

JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2008, 135 (04) :732-738

[3]

Baumgartner H, 2018, EUR HEART J, V39, P1980, DOI [10.1093/eurheartj/ehx636, 10.1093/eurheartj/ehx391]

[4] 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients [J].

Gleason, Thomas G. ;

Reardon, Michael J. ;

Popma, Jeffrey J. ;

Deeb, Michael ;

Yakubov, Steven J. ;

Lee, Joon S. ;

Kleiman, Neal S. ;

Chetcuti, Stan ;

Hermiller, James B., Jr. ;

Heiser, John ;

Merhi, William ;

Zorn, George L., III ;

Tadros, Peter ;

Robinson, Newell ;

Petrossian, George ;

Hughes, G. Chad ;

Harrison, J. Kevin ;

Conte, John V. ;

Mumtaz, Mubashir ;

Oh, Jae K. ;

Huang, Jian ;

Adams, David H. .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2018, 72 (22) :2687-2696

[5] Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves [J].

Guyot, Patricia ;

Ades, A. E. ;

Ouwens, Mario J. N. M. ;

Welton, Nicky J. .

BMC MEDICAL RESEARCH METHODOLOGY, 2012, 12

[6]

Higgins J.P., 2011, BMJ, V343, pd5928, DOI [DOI 10.1136/BMJ.D5928, 10.1136/bmj.d5928]

[7]

Kappetein AP, 2012, J AM COLL CARDIOL, V60, P1438, DOI [10.1016/j.jacc.2012.09.001, 10.1093/ejcts/ezs533]

[8] Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis [J].

Kodali, Susheel ;

Thourani, Vinod H. ;

White, Jonathon ;

Malaisrie, S. Chris ;

Lim, Scott ;

Greason, Kevin L. ;

Williams, Mathew ;

Guerrero, Mayra ;

Eisenhauer, Andrew C. ;

Kapadia, Samir ;

Kereiakes, Dean J. ;

Herrmann, Howard C. ;

Babaliaros, Vasilis ;

Szeto, Wilson Y. ;

Hahn, Rebecca T. ;

Pibarot, Philippe ;

Weissman, Neil J. ;

Leipsic, Jonathon ;

Blanke, Philipp ;

Whisenant, Brian K. ;

Suri, Rakesh M. ;

Makkar, Raj R. ;

Ayele, Girma M. ;

Svensson, Lars G. ;

Webb, John G. ;

Mack, Michael J. ;

Smith, Craig R. ;

Leon, Martin B. .

EUROPEAN HEART JOURNAL, 2016, 37 (28) :2252-2262

[9] Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients [J].

Leon, Martin B. ;

Smith, Craig R. ;

Mack, Michael J. ;

Makkar, Raj R. ;

Svensson, Lars G. ;

Kodali, Susheel K. ;

Thourani, Vinod H. ;

Tuzcu, E. Murat ;

Miller, D. Craig ;

Herrmann, Howard C. ;

Doshi, Darshan ;

Cohen, David J. ;

Pichard, Augusto D. ;

Kapadia, Samir ;

Dewey, Todd ;

Babaliaros, Vasilis ;

Szeto, Wilson Y. ;

Williams, Mathew R. ;

Kereiakes, Dean ;

Zajarias, Alan ;

Greason, Kevin L. ;

Whisenant, Brian K. ;

Hodson, Robert W. ;

Moses, Jeffrey W. ;

Trento, Alfredo ;

Brown, David L. ;

Fearon, William F. ;

Pibarot, Philippe ;

Hahn, Rebecca T. ;

Jaber, Wael A. ;

Anderson, William N. ;

Alu, Maria C. ;

Webb, John G. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 374 (17) :1609-1620

[10] Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients [J].

Mack, M. J. ;

Leon, M. B. ;

Thourani, V. H. ;

Makkar, R. ;

Kodali, S. K. ;

Russo, M. ;

Kapadia, S. R. ;

Malaisrie, S. C. ;

Cohen, D. J. ;

Pibarot, P. ;

Leipsic, J. ;

Hahn, R. T. ;

Blanke, P. ;

Williams, M. R. ;

McCabe, J. M. ;

Brown, D. L. ;

Babaliaros, V. ;

Goldman, S. ;

Szeto, W. Y. ;

Genereux, P. ;

Pershad, A. ;

Pocock, S. J. ;

Alu, M. C. ;

Webb, J. G. ;

Smith, C. R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2019, 380 (18) :1695-1705

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