Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials A Consensus Report From the Valve Academic Research Consortium

被引:524
作者
Leon, Martin B. [1 ]
Piazza, Nicolo [1 ]
Nikolsky, Eugenia [1 ]
Blackstone, Eugene H. [1 ]
Cutlip, Donald E. [1 ]
Kappetein, Arie Pieter [1 ]
Krucoff, Mitchell W. [1 ]
Mack, Michael [1 ]
Mehran, Roxana [1 ]
Miller, Craig [1 ]
Morel, Marie-angele [1 ]
Petersen, John [1 ]
Popma, Jeffrey J. [1 ]
Takkenberg, Johanna J. M. [1 ]
Vahanian, Alec [1 ]
van Es, Gerrit-Anne [1 ]
Vranckx, Pascal [1 ]
Webb, John G. [1 ]
Windecker, Stephan [1 ]
Serruys, Patrick W. [1 ]
机构
[1] Columbia Univ, Med Ctr, Ctr Intervent Vasc Therapy, Ctr Heart, New York, NY 10032 USA
关键词
transcatheter aortic valve implantation; ACUTE-RENAL-FAILURE; ACUTE CORONARY SYNDROMES; ACUTE MYOCARDIAL-INFARCTION; ACUTE KIDNEY INJURY; HIGH-RISK PATIENTS; PAROXYSMAL ATRIAL-FIBRILLATION; MEDTRONIC COREVALVE SYSTEM(R); VALVULAR HEART-DISEASE; PROGNOSTIC-SIGNIFICANCE; UNFRACTIONATED HEPARIN;
D O I
10.1016/j.jacc.2010.12.005
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and Results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the U. S. Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included: 1) respect for the historical legacy of surgical valve guidelines; 2) identification of pathophysiological mechanisms associated with clinical events; 3) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Conclusions Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes. (J Am Coll Cardiol 2011;57:253-69) (C) 2011 by the American College of Cardiology Foundation
引用
收藏
页码:253 / 269
页数:17
相关论文
共 168 条
[1]   The outcome of acute renal failure in the intensive care unit according to RIFLE: Model application, sensitivity, and predictability [J].
Abosaif, NY ;
Tolba, YA ;
Heap, M ;
Russell, J ;
El Nahas, AM .
AMERICAN JOURNAL OF KIDNEY DISEASES, 2005, 46 (06) :1038-1048
[2]  
Akins CW, 2008, ANN THORAC SURG, V85, P1490, DOI [10.1016/j.athoracsur.2007.12.082, 10.1016/j.ejcts.2007.12.055]
[3]   Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions-Need for a Reappraisal? (Response) [J].
Akins, Cary W. ;
Blackstone, Eugene H. ;
Miller, Craig ;
Kouchoukos, Nicholas T. ;
Turina, Marko I. .
ANNALS OF THORACIC SURGERY, 2009, 87 (02) :359-360
[4]   Unexpected Complications of Transapical Aortic Valve Implantation [J].
Al-Attar, Nawwar ;
Ghodbane, Walid ;
Himbert, Dominique ;
Rau, Cederic ;
Raffoul, Richard ;
Messika-Zeitoun, David ;
Brochet, Eric ;
Vahanian, Alec ;
Nataf, Patrick .
ANNALS OF THORACIC SURGERY, 2009, 88 (01) :90-94
[5]   Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Q-wave myocardial infarction - Results of the thrombolysis in myocardial infarction (TIMI) 11B trial [J].
Antman, EM ;
McCabe, CH ;
Gurfinkel, EP ;
Turpie, AGG ;
Bernink, PJLM ;
Salein, D ;
de Luna, AB ;
Fox, K ;
Lablanche, JM ;
Radley, D ;
Premmereur, J ;
Braunwald, E .
CIRCULATION, 1999, 100 (15) :1593-1601
[6]   Association Between Carotid and Coronary Artery Disease in Patients With Aortic Valve Stenosis: An Angiographic Study [J].
Antonini-Canterin, Francesco ;
Leiballi, Elisa ;
Capanna, Michele ;
Burelli, Claudio ;
Cassin, Matteo ;
Macor, Franco ;
Grandis, Umberto ;
Nicolosi, Gian Luigi .
ANGIOLOGY, 2009, 60 (05) :596-600
[7]   Renal dysfunction after myocardial revascularization [J].
Antunes, PE ;
Prieto, D ;
de Oliveira, JF ;
Antunes, MJ .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2004, 25 (04) :597-604
[8]   Risk of acute kidney injury in patients with severe aortic valve stenosis undergoing transcatheter valve replacement [J].
Aregger, Fabienne ;
Wenaweser, Peter ;
Hellige, Gerrit J. ;
Kadner, Alexander ;
Carrel, Thierry ;
Windecker, Stefan ;
Frey, Felix J. .
NEPHROLOGY DIALYSIS TRANSPLANTATION, 2009, 24 (07) :2175-2179
[9]   Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic value replacement [J].
Bagur, Rodrigo ;
Webb, John G. ;
Nietlispach, Fabian ;
Dumont, Eric ;
De Larochelliere, Robert ;
Doyle, Daniel ;
Masson, Jean-Bernard ;
Gutierrez, Marcos J. ;
Clavel, Marie-Annick ;
Bertrand, Olivier F. ;
Pibarot, Philippe ;
Rodes-Cabau, Josep .
EUROPEAN HEART JOURNAL, 2010, 31 (07) :865-874
[10]   Predictors of paroxysmal atrial fibrillation in patients undergoing aortic valve replacement [J].
Banach, Maciej ;
Goch, Aleksander ;
Misztal, Malgorzata ;
Rysz, Jacek ;
Jaszewski, Ryszard ;
Goch, Jan Henryk .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2007, 134 (06) :1569-1576