Percutaneous Coronary Intervention in Perspective Drug-Eluting Stents as a Model for Regulatory Review

被引:3
作者
Kandzari, David E. [1 ]
Farb, Andrew [2 ]
Boam, Ashley B. [2 ]
机构
[1] Scripps Clin, Div Cardiovasc Dis, La Jolla, CA 92037 USA
[2] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA
关键词
delivery of health care; public policy; government regulation; stents; LONG-TERM OUTCOMES; RANDOMIZED CLINICAL-TRIALS; BARE-METAL STENTS; OFF-LABEL; ANTIPLATELET THERAPY; THROMBOSIS; IMPLANTATION; PREDICTORS; SAFETY; METAANALYSIS;
D O I
10.1161/CIRCINTERVENTIONS.109.871996
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页码:574 / 579
页数:6
相关论文
共 39 条
[1]  
American College of Cardiology, 2006, J Am Coll Cardiol, V48, pe1, DOI 10.1016/j.jacc.2006.05.021
[2]   Off-label stent therapy - 2-year comparison of drug-eluting versus bare-metal stents [J].
Applegate, Robert J. ;
Sacrinty, Matthew T. ;
Kutcher, Michael A. ;
Santos, Renato M. ;
Gandhi, Sanjay K. ;
Baki, Talal T. ;
Little, William C. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2008, 51 (06) :607-614
[3]   A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents [J].
Babapulle, MN ;
Joseph, L ;
Bélisle, P ;
Brophy, JM ;
Eisenberg, MJ .
LANCET, 2004, 364 (9434) :583-591
[4]   Late thrombosis of drug-eluting stents: A meta-analysis of randomized clinical trials [J].
Bavry, Anthony A. ;
Kumbhani, Dharam J. ;
Helton, Thomas J. ;
Borek, Przemyslaw P. ;
Mood, Girish R. ;
Bhatt, Deepak L. .
AMERICAN JOURNAL OF MEDICINE, 2006, 119 (12) :1056-1061
[5]   Outcomes and complications associated with off-label and untested use of drug-eluting stents [J].
Beohar, Nirat ;
Davidson, Charles J. ;
Kip, Kevin E. ;
Goodreau, Lynne ;
Aslanidou Vlachos, Helen ;
Meyers, Sheridan N. ;
Benzuly, Keith H. ;
Flaherty, James D. ;
Ricciardi, Mark J. ;
Bennett, Charles L. ;
Williams, David O. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2007, 297 (18) :1992-2000
[6]   Stent thrombosis late after implantation of first-generation drug-eluting stents - A cause for concern [J].
Camenzind, Edoardo ;
Steg, P. Gabriel ;
Wijns, William .
CIRCULATION, 2007, 115 (11) :1440-1455
[7]  
*CLIN NONCLIN STUD, COR DRUG ELUT STENT
[8]   Clinical end points in coronary stent trials - A case for standardized definitions [J].
Cutlip, Donald E. ;
Windecker, Stephan ;
Mehran, Roxana ;
Boam, Ashley ;
Cohen, David J. ;
van Es, Gerrit-Anne ;
Steg, P. Gabriel ;
Morel, Marie-angele ;
Mauri, Laura ;
Vranckx, Pascal ;
McFadden, Eugene ;
Lansky, Alexandra ;
Hamon, Martial ;
Krucoff, Mitchell W. ;
Serruys, Patrick W. .
CIRCULATION, 2007, 115 (17) :2344-2351
[9]   Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation [J].
Eisenstein, Eric L. ;
Anstrom, Kevin J. ;
Kong, David F. ;
Shaw, Linda K. ;
Tuttle, Robert H. ;
Mark, Daniel B. ;
Kramer, Judith M. ;
Harrington, Robert A. ;
Matchar, David B. ;
Kandzari, David E. ;
Peterson, Eric D. ;
Schulman, Kevin A. ;
Califf, Robert M. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2007, 297 (02) :159-168
[10]  
FACTSET C, 2009, WWW CALLSTREET COM A, P14