A New Strategy for Discontinuation of Dual Antiplatelet Therapy The RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation)

被引：550

作者：

Kim, Byeong-Keuk

Hong, Myeong-Ki ^{[1
,2
]}

Shin, Dong-Ho

Nam, Chung-Mo ^{[3
]}

Kim, Jung-Sun

Ko, Young-Guk

Choi, Donghoon

Kang, Tae-Soo ^{[4
]}

Park, Byoung-Eun ^{[4
]}

Kang, Woong-Chol ^{[5
]}

Lee, Seung-Hwan ^{[6
]}

Yoon, Jung-Han ^{[6
]}

Hong, Bum-Kee ^{[7
]}

Kwon, Hyuck-Moon ^{[7
]}

Jang, Yangsoo ^{[2
]}

机构：

[1] Yonsei Univ, Coll Med, Div Cardiol, Severance Cardiovasc Hosp, Seoul 120752, South Korea

[2] Yonsei Univ, Coll Med, Severance Biomed Sci Inst, Seoul 120752, South Korea

[3] Yonsei Univ, Coll Med, Dept Prevent Med & Biostat, Seoul 120752, South Korea

[4] Dankook Univ, Coll Med, Cheonan, South Korea

[5] Gachon Univ, Coll Med, Inchon, South Korea

[6] Yonsei Univ, Wonju Coll Med, Wonju, South Korea

[7] Kangnam Severance Hosp, Seoul, South Korea

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2012年 / 60卷 / 15期

关键词：

antiplatelet therapy; coronary artery disease; drug-eluting stents; CORONARY-ARTERY LESIONS; DURATION; MULTICENTER; OUTCOMES; SYSTEM;

D O I：

10.1016/j.jacc.2012.06.043

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. Background There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation. Methods We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES + 3-month DAPT, n = 1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n = 1,058). We hypothesized that the E-ZES + 3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year. Results The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES + 3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p = 0.84; p < 0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p = 0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p = 0.65) without its further occurrence after cessation of clopidogrel in the E-ZES + 3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p = 0.70). Conclusions E-ZES + 3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079) (J Am Coll Cardiol 2012;60:1340-8) (C) 2012 by the American College of Cardiology Foundation

引用

页码：1340 / 1348

页数：9

共 19 条

[1] Incidence, correlates, and clinical impact of nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents [J].

Ben-Dor, Itsik ;

Torguson, Rebecca ;

Scheinowitz, Mickey ;

Li, Yanlin ;

Delhaye, Cedric ;

Wakabayashi, Kohei ;

Maluenda, Gabriel ;

Syed, Asmir I. ;

Collins, Sara D. ;

Gonzalez, Manuel A. ;

Gaglia, Michael A., Jr. ;

Xue, Zhenyi ;

Kaneshige, Kimberly ;

Satler, Lowell F. ;

Suddath, William O. ;

Kent, Kenneth M. ;

Pichard, Augusto D. ;

Waksman, Ron .

AMERICAN HEART JOURNAL, 2010, 159 (05) :871-875

[2] 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

[3] 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

[4] Six-Month Versus 12-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents The Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) Randomized, Multicenter Study [J].

Gwon, Hyeon-Cheol ;

Hahn, Joo-Yong ;

Park, Kyung Woo ;

Bin Song, Young ;

Chae, In-Ho ;

Lim, Do-Sun ;

Han, Kyoo-Rok ;

Choi, Jin-Ho ;

Choi, Seung-Hyuk ;

Kang, Hyun-Jae ;

Koo, Bon-Kwon ;

Ahn, Taehoon ;

Yoon, Jung-Han ;

Jeong, Myung-Ho ;

Hong, Taek-Jong ;

Chung, Woo-Young ;

Choi, Young-Jin ;

Hur, Seung-Ho ;

Kwon, Hyuck-Moon ;

Jeon, Dong-Woon ;

Kim, Byung-Ok ;

Park, Si-Hoon ;

Lee, Nam-Ho ;

Jeon, Hui-Kyung ;

Jang, Yangsoo ;

Kim, Hyo-Soo .

CIRCULATION, 2012, 125 (03) :505-U119

[5] Three-Month Dual Antiplatelet Therapy After Implantation of Zotarolimus-Eluting Stents - The DATE (Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent) Registry [J].

Hahn, Joo-Yong ;

Bin Song, Young ;

Choi, Jin-Ho ;

Choi, Sung-Hyuk ;

Lee, Sung Yun ;

Park, Hun Sik ;

Hur, Seung Ho ;

Lee, Sahng ;

Han, Kyoo-Rok ;

Rha, Seung-Woon ;

Cho, Byung Ryul ;

Park, Jong-Sun ;

Yoon, Junghan ;

Lim, Do Sun ;

Lee, Sang Hoon ;

Gwon, Hyeon-Cheol .

CIRCULATION JOURNAL, 2010, 74 (11) :2314-2321

[6] Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents [J].

Iakovou, I ;

Schmidt, T ;

Bonizzoni, E ;

Ge, L ;

Sangiorgi, GM ;

Stankovic, G ;

Airoldi, F ;

Chieffo, A ;

Montorfano, M ;

Carlino, M ;

Michev, I ;

Corvaja, N ;

Briguori, C ;

Gerckens, U ;

Grube, E ;

Colombo, A .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2005, 293 (17) :2126-2130

[7] Dual Antiplatelet Therapy Duration and Clinical Outcomes Following Treatment With Zotarolimus-Eluting Stents [J].

Kandzari, David E. ;

Barker, Colin S. ;

Leon, Martin B. ;

Mauri, Laura ;

Wijns, William ;

Fajadet, Jean ;

Mehran, Roxana .

JACC-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (10) :1119-1128

[8] Will We Ever Know the Optimal Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation? [J].

Kastrati, Adnan ;

Byrne, Robert A. ;

Schulz, Stefanie .

JACC-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (10) :1129-1132

[9] Evaluation in 3 Months Duration of Neointimal Coverage After Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography The ENDEAVOR OCT Trial [J].

Kim, Jung-Sun ;

Jang, Ik-Kyung ;

Fan, Chunyu ;

Kim, Tae Hoon ;

Kim, Jin-Sun ;

Park, Sang Min ;

Choi, Eui-Young ;

Lee, Sang Hak ;

Ko, Young-Guk ;

Choi, Donghoon ;

Hong, Myeong-Ki ;

Jang, Yangsoo .

JACC-CARDIOVASCULAR INTERVENTIONS, 2009, 2 (12) :1240-1247

[10] A Randomized Comparison of the Endeavor Zotarolimus-Eluting Stent Versus the TAXUS Paclitaxel-Eluting Stent in De Novo Native Coronary Lesions 12-Month Outcomes From the ENDEAVOR IV Trial [J].

Leon, Martin B. ;

Mauri, Laura ;

Popma, Jeffrey J. ;

Cutlip, Donald E. ;

Nikolsky, Eugenia ;

O'Shaughnessy, Charles ;

Overlie, Paul A. ;

McLaurin, Brent T. ;

Solomon, Stuart L. ;

Douglas, John S., Jr. ;

Ball, Michael W. ;

Caputo, Ronald P. ;

Jain, Ash ;

Tolleson, Thaddeus R. ;

Reen, Bernard M., III ;

Kirtane, Ajay J. ;

Fitzgerald, Peter J. ;

Thompson, Kweli ;

Kandzari, David E. .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2010, 55 (06) :543-554

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