Short- and Long-Term Outcomes With Drug-Eluting and Bare-Metal Coronary Stents A Mixed-Treatment Comparison Analysis of 117 762 Patient-Years of Follow-Up From Randomized Trials

被引:472
作者
Bangalore, Sripal [1 ]
Kumar, Sunil [2 ]
Fusaro, Mario
Amoroso, Nicholas
Attubato, Michael J.
Feit, Frederick
Bhatt, Deepak L. [3 ,4 ]
Slater, James
机构
[1] NYU, Sch Med, Cardiac Catheterizat Lab, Leon H Charney Div Cardiol, New York, NY 10016 USA
[2] Univ Nebraska, Omaha, NE 68182 USA
[3] Brigham & Womens Hosp, VA Boston Healthcare Syst, Boston, MA 02115 USA
[4] Harvard Univ, Sch Med, Boston, MA USA
关键词
drug-eluting stents; paclitaxel; pannus formation; sirolimus; everolimus; zotarolimus; stents; ELEVATION MYOCARDIAL-INFARCTION; GLYCOPROTEIN IIB/IIIA INHIBITOR; DE-NOVO LESIONS; CLINICAL-OUTCOMES; ARTERY LESIONS; DIABETES-MELLITUS; UNCOATED STENTS; ANGIOGRAPHIC OUTCOMES; REAL-WORLD; MULTICENTER TRIAL;
D O I
10.1161/CIRCULATIONAHA.112.097014
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background-Drug-eluting stents (DES) have been in clinical use for nearly a decade; however, the relative short- and long-term efficacy and safety of DES compared with bare-metal stents (BMS) and among the DES types are less well defined. Methods and Results-PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials, until March 2012, that compared any of the Food and Drug Administration-approved durable stent and polymer DES (sirolimus-eluting stent [SES], paclitaxel-eluting stent [PES], everolimus-eluting stent [EES], zotarolimus-eluting stent [ZES], and ZES-Resolute [ZES-R]) with each other or against BMS for de novo coronary lesions, enrolling at least 100 patients and with follow-up of at least 6 months. Short-term (<= 1 year) and long-term efficacy (target-vessel revascularization, target-lesion revascularization) and safety (death, myocardial infarction, stent thrombosis) outcomes were evaluated and trial-level data pooled by both mixed-treatment comparison and direct comparison analyses. From 76 randomized clinical trials with 117 762 patient-years of follow-up, compared with BMS, each DES reduced long-term target-vessel revascularization (39%-61%), but the magnitude varied by DES type (EES similar to SES similar to ZES-R similar to PES similar to ZES>BMS), with a >42% probability that EES had the lowest target-vessel revascularization rate. There was no increase in the risk of any long-term safety outcomes, including stent thrombosis, with any DES (versus BMS). In addition, there was reduction in myocardial infarction (all DES except PES versus BMS) and stent thrombosis (with EES versus BMS: Rate ratio, 0.51; 95% credibility interval, 0.35-0.73). The safest DES appeared to be EES (>86% probability), with reduction in myocardial infarction and stent thrombosis compared with BMS. Short-term outcomes were similar to long-term outcomes, with SES, ZES-R, and everolimus-eluting stent being the most efficacious and EES being the safest stent. Conclusions-DES are highly efficacious at reducing the risk of target-vessel revascularization without an increase in any safety outcomes, including stent thrombosis. However, among the DES types, there were considerable differences, such that EES, SES, and ZES-R were the most efficacious and EES was the safest stent. (Circulation. 2012;125:2873-2891.)
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页码:2873 / +
页数:43
相关论文
共 141 条
[31]   Bias in meta-analysis detected by a simple, graphical test [J].
Egger, M ;
Smith, GD ;
Schneider, M ;
Minder, C .
BMJ-BRITISH MEDICAL JOURNAL, 1997, 315 (7109) :629-634
[32]   Long-Term Safety and Efficacy With Paclitaxel-Eluting Stents 5-Year Final Results of the TAXUS IV Clinical Trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) [J].
Ellis, Stephen G. ;
Stone, Gregg W. ;
Cox, David A. ;
Hermiller, James ;
O'Shaughnessy, Charles ;
Mann, Tift ;
Turco, Mark ;
Caputo, Ronald ;
Bergin, Patrick J. ;
Bowman, Thomas S. ;
Baim, Donald S. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2009, 2 (12) :1248-1259
[33]   A Randomized comparison of paclitaxel-eluting Stents versus bare-metal Stents for treatment of unprotected left main coronary artery stenosis [J].
Erglis, Andrejs ;
Narbute, Inga ;
Kumsars, Indulis ;
Jegere, Sanda ;
Mintale, Iveta ;
Zakke, Ilja ;
Strazdins, Uldis ;
Saltups, Andris .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2007, 50 (06) :491-497
[34]   Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine encapsulated stent for treatment of native coronary artery lesions:: Clinical and angiographic results of the ENDEAVOR II trial [J].
Fajadet, Jean ;
Wijns, William ;
Laarman, Gert-Jan ;
Kuck, Karl-Heinz ;
Ormiston, John ;
Munzel, Thomas ;
Popma, Jeffrey J. ;
Fitzgerald, Peter J. ;
Bonan, Raoul ;
Kuntz, Richard E. .
CIRCULATION, 2006, 114 (08) :798-806
[35]   A NOTE ON GRAPHICAL PRESENTATION OF ESTIMATED ODDS RATIOS FROM SEVERAL CLINICAL-TRIALS [J].
GALBRAITH, RF .
STATISTICS IN MEDICINE, 1988, 7 (08) :889-894
[36]   Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice -: The SORT OUT II Randomized trial [J].
Galloe, Anders M. ;
Thuesen, Leif ;
Kelbaek, Henning ;
Thayssen, Per ;
Rasmussen, Klaus ;
Hansen, Peter R. ;
Bligaard, Niels ;
Saunamaki, Kari ;
Junker, Anders ;
Aaroe, Jens ;
Abildgaard, Ulrik ;
Ravkilde, Jan ;
Engstrom, Thomas ;
Jensen, Jan S. ;
Andersen, Henning R. ;
Botker, Hans E. ;
Galatius, Soren ;
Kristensen, Steen D. ;
Madsen, Jan K. ;
Krusell, Lars R. ;
Abildstrom, Steen Z. ;
Stephansen, Ghita B. ;
Lassen, Jens F. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 299 (04) :409-416
[37]   Firebird sirolimus eluting stent versus bare mental stent in patients with ST-segment elevation myocardial infarction [J].
Gao Hai ;
Yan Hong-bing ;
Zhu Xiao-ling ;
Li Nan ;
Ai Hui ;
Wang Jian ;
Li Shi-ying ;
Yang Duo .
CHINESE MEDICAL JOURNAL, 2007, 120 (10) :863-867
[38]   3-Year Clinical Follow-Up of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions The SPIRIT II Trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) [J].
Garg, Scot ;
Serruys, Patrick ;
Onuma, Yoshinobu ;
Dorange, Cecile ;
Veldhof, Susan ;
Miquel-Hebert, Karine ;
Sudhir, Krishnankutty ;
Boland, Jean ;
Huber, Kurt ;
Garcia, Eulogio ;
te Riele, Jan A. M. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2009, 2 (12) :1190-1198
[39]   A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology -: The TAXi trial [J].
Goy, JJ ;
Stauffier, JC ;
Siegenthaler, M ;
Benoît, A ;
Seydoux, C .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2005, 45 (02) :308-311
[40]   A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: Final results of the ZoMaxx II trial [J].
Gray, William A. ;
Yeung, Alan C. ;
Cutlip, Donald E. ;
Popma, Jeffrey J. ;
Fitzgerald, Peter J. ;
Williams, David O. ;
Heuer, Hubertus ;
O'Shaughnessy, Charles D. ;
Overlie, Paul A. ;
Mann, J. Tift ;
Cannon, Louis A. ;
Hermiller, James B. ;
Henry, Timothy D. ;
Whitbourn, Robert ;
Stuckey, Thomas D. ;
Midei, Mark G. ;
Coe, Jessie ;
Schwartz, Lewis B. .
INTERNATIONAL JOURNAL OF CARDIOLOGY, 2012, 157 (01) :96-101