Clinical trials of transcatheter aortic valve replacement

被引：13

作者：

Al-Azizi, Karim ^{[1
]}

Hamandi, Mohanad ^{[1
]}

Mack, Michael ^{[1
]}

机构：

[1] Baylor Scott & White Heart Hosp, Plano, TX USA

来源：

HEART | 2019年 / 105卷

关键词：

ANTIPLATELET THERAPY; IMPLANTATION; STENOSIS; RISK; PROTECTION; TAVI; ASPIRIN; DEVICE;

D O I：

10.1136/heartjnl-2018-313511

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Transcatheter aortic valve replacement(TAVR) has emerged as an effective treatment option in patients with severe aortic stenosis, in large part due to a robust evidence base generated by a series of randomised controlled trials (RCTs). During the past decade more than 15 000 patients have been randomised worldwide in nine clinical trials, mostly for regulatory approval in the USA, making it one of the most carefully scrutinised medical devices at the time of introduction into clinical practice. Initial trials were performed in inoperable or extreme risk patients compared to medical therapy and demonstrated superiority. Subsequent RCTs compared TAVR to surgical aortic valve replacement in high and intermediate surgical risk patients and TAVR was found to be non-inferior in all studies. RCTs of low surgical risk patients have completed enrolment and 1 year outcomes will be available in early 2019. The details of the trials, trial results, outcomes and remaining clinical questions are summarised in this article.

引用

页码：S6 / S9

页数：4

共 21 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] Population-Wide Trends in Aortic Stenosis Incidence and Outcomes [J].

Bonow, Robert O. ;

Greenland, Philip .

CIRCULATION, 2015, 131 (11) :969-971

[3] Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis - First human case description [J].

Cribier, A ;

Eltchaninoff, H ;

Bash, A ;

Borenstein, N ;

Tron, C ;

Bauer, F ;

Derumeaux, G ;

Anselme, F ;

Laborde, F ;

Leon, MB .

CIRCULATION, 2002, 106 (24) :3006-3008

[4] Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis The CLEAN-TAVI Randomized Clinical Trial [J].

Haussig, Stephan ;

Mangner, Norman ;

Dwyer, Michael G. ;

Lehmkuhl, Lukas ;

Luecke, Christian ;

Woitek, Felix ;

Holzhey, David M. ;

Mohr, Friedrich W. ;

Gutberlet, Matthias ;

Zivadinov, Robert ;

Schuler, Gerhard ;

Linke, Axel .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 316 (06) :592-601

[5] Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement [J].

Kapadia, Samir R. ;

Kodali, Susheel ;

Makkar, Raj ;

Mehran, Roxana ;

Lazar, Ronald M. ;

Zivadinov, Robert ;

Dwyer, Michael G. ;

Jilaihawi, Hasan ;

Virmani, Renu ;

Anwaruddin, Saif ;

Thourani, Vinod H. ;

Nazif, Tamim ;

Mangner, Norman ;

Woitek, Felix ;

Krishnaswamy, Amar ;

Mick, Stephanie ;

Chakravarty, Tarun ;

Nakamura, Mamoo ;

McCabe, James M. ;

Satler, Lowell ;

Zajarias, Alan ;

Szeto, Wilson Y. ;

Svensson, Lars ;

Alu, Maria C. ;

White, Roseann M. ;

Kraemer, Carlye ;

Parhizgar, Azin ;

Leon, Martin B. ;

Linke, Axel .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2017, 69 (04) :367-377

[6] The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial [J].

Khawaja, Muhammed Zeeshan ;

Wang, Duolao ;

Pocock, Stuart ;

Redwood, Simon Robert ;

Thomas, Martyn Rhys .

TRIALS, 2014, 15

[7] Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial) [J].

Lansky, Alexandra J. ;

Brown, David ;

Pena, Constantino ;

Pietras, Cody G. ;

Parise, Helen ;

Ng, Vivian G. ;

Meller, Stephanie ;

Abrams, Kevin J. ;

Cleman, Michael ;

Margolis, Pauliina ;

Petrossian, George ;

Brickman, Adam M. ;

Voros, Szilard ;

Moses, Jeffrey ;

Forrest, John K. .

AMERICAN JOURNAL OF CARDIOLOGY, 2016, 118 (10) :1519-1526

[8] A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results fromthe DEFLECT III trial [J].

Lansky, Alexandra J. ;

Schofer, Joachim ;

Tchetche, Didier ;

Stella, Pieter ;

Pietras, Cody G. ;

Parise, Helen ;

Abrams, Kevin ;

Forrest, John K. ;

Cleman, Michael ;

Reinoehl, Jochen ;

Cuisset, Thomas ;

Blackman, Daniel ;

Bolotin, Gil ;

Spitzer, Stefan ;

Kappert, Utz ;

Gilard, Martine ;

Modine, Thomas ;

Hildick-Smith, David ;

Haude, Michael ;

Margolis, Pauliina ;

Brickman, Adam M. ;

Voros, Szilard ;

Baumbach, Andreas .

EUROPEAN HEART JOURNAL, 2015, 36 (31) :2070-2078

[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 Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. [J].

Leon, Martin B. ;

Smith, Craig R. ;

Mack, Michael ;

Miller, D. Craig ;

Moses, Jeffrey W. ;

Svensson, Lars G. ;

Tuzcu, E. Murat ;

Webb, John G. ;

Fontana, Gregory P. ;

Makkar, Raj R. ;

Brown, David L. ;

Block, Peter C. ;

Guyton, Robert A. ;

Pichard, Augusto D. ;

Bavaria, Joseph E. ;

Herrmann, Howard C. ;

Douglas, Pamela S. ;

Petersen, John L. ;

Akin, Jodi J. ;

Anderson, William N. ;

Wang, Duolao ;

Pocock, Stuart .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (17) :1597-1607

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