Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis

被引:166
作者
Navarese, Eliano P. [1 ]
Tandjung, Kenneth [2 ]
Claessen, Bimmer [3 ]
Andreotti, Felicita [4 ]
Kowalewski, Mariusz [1 ]
Kandzari, David E. [5 ]
Kereiakes, Dean J. [6 ,7 ]
Waksman, Ron [8 ]
Mauri, Laura [9 ]
Meredith, Ian T. [10 ]
Finn, Aloke V. [11 ]
Kim, Hyo-Soo [12 ]
Kubica, Jacek [1 ]
Suryapranata, Harry [13 ]
Aprami, Toni Mustahsani [14 ]
Di Pasquale, Giuseppe [15 ]
von Birgelen, Clemens [2 ,16 ]
Kedhi, Elvin [17 ]
机构
[1] Nicholas Copernicus Univ, Ludwik Rydygier Coll Med, Dept Cardiol & Internal Med, Bydgoszcz, Poland
[2] Med Spectrum Twente, Thoraxcentrum Twente, Dept Cardiol, Enschede, Netherlands
[3] Univ Amsterdam, Acad Med Ctr, Dept Cardiol, NL-1012 WX Amsterdam, Netherlands
[4] Catholic Univ, Dept Cardiovasc Sci, Rome, Italy
[5] Piedmont Heart Inst, Atlanta, GA USA
[6] Christ Hosp Heart, Dept Cardiol, Cincinnati, OH USA
[7] Lindner Res Ctr, Vasc Ctr, Cincinnati, OH USA
[8] MedStar Washington Hosp Ctr, Div Cardiol, Washington, DC USA
[9] Harvard Univ, Brigham & Womens Hosp, Sch Med, Dept Cardiol, Boston, MA 02115 USA
[10] Monash Med Ctr, Dept Cardiol, MonashHeart, Melbourne, Vic, Australia
[11] Emory Univ, Sch Med, Dept Cardiol, Atlanta, GA USA
[12] Seoul Natl Univ, Coll Med, Dept Internal Med, Div Cardiol, Seoul 151, South Korea
[13] Radboud Univ Nijmegen Med Ctr, Dept Cardiol, Nijmegen, Netherlands
[14] Padjadjaran Univ Hosp Hasan Sadikin, Dept Cardiol, Bandung, Indonesia
[15] Osped Maggiore Bologna, Unita Osped Cardiol, Bologna, Italy
[16] Univ Twente, MIRA Inst Biomed Technol & Tech Med, NL-7500 AE Enschede, Netherlands
[17] Isala Klin, Dept Cardiol, NL-8025 AB Zwolle, Netherlands
来源
BMJ-BRITISH MEDICAL JOURNAL | 2013年 / 347卷
关键词
PERCUTANEOUS CORONARY INTERVENTION; ELEVATION MYOCARDIAL-INFARCTION; RANDOMIZED CONTROLLED-TRIAL; BARE-METAL STENT; DUAL ANTIPLATELET THERAPY; REAL-WORLD PATIENTS; 5-YEAR FOLLOW-UP; XIENCE V STENTS; ARTERY-DISEASE; DIABETES-MELLITUS;
D O I
10.1136/bmj.f6530
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES). Design Network meta-analysis of randomised controlled trials. Data sources and study selection Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES. Primary outcomes Safety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond. Results 60 randomised controlled trials were compared involving 63 242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles. Conclusions The newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.
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相关论文
共 121 条
[1]   Comparison of Resolute Zotarolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With De Novo Long Coronary Artery Lesions A Randomized LONG-DES IV Trial [J].
Ahn, Jung-Min ;
Park, Duk-Woo ;
Kim, Young-Hak ;
Song, HaeGeun ;
Cho, Young-Rak ;
Kim, Won-Jang ;
Lee, Jong-Young ;
Kang, Soo-Jin ;
Lee, Seung-Whan ;
Lee, Cheol Whan ;
Park, Seong-Wook ;
Yun, Sung-Cheol ;
Han, Seungbong ;
Lee, Sung Yun ;
Lee, Bong-Ki ;
Cho, Jang-Hyun ;
Yang, Tae-Hyun ;
Lee, Nae-Hee ;
Yang, Joo-Young ;
Park, Jong-Seon ;
Shin, Won-Yong ;
Kim, Moo Hyun ;
Bae, Jang Ho ;
Kim, Myeong-Kon ;
Yoon, Junghan ;
Park, Seung-Jung .
CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2012, 5 (05) :633-640
[2]   Evaluation of the Effects of Everolimus-Eluting and Paclitaxel-Eluting Stents on Target Lesions With Jailed Side Branches: 2-Year Results From the SPIRIT III Randomized Trial [J].
Applegate, Robert ;
Hermiller, James ;
Williams, Jerome ;
Gordon, Paul ;
Doostzadeh, Julie ;
Cao, Sherry ;
Su, Xiaolu ;
Sudhir, Krishnankutty ;
Lansky, Alexandra ;
Simonton, Charles ;
Stone, Gregg .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2010, 76 (05) :644-651
[3]   Long-Term (Three-Year) Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents (from the SPIRIT III Trial) [J].
Applegate, Robert J. ;
Yaqub, Manejeh ;
Hermiller, James B. ;
Sood, Poornima ;
Yu, Shui ;
Doostzadeh, Julie ;
Williams, Jerome E. ;
Farhat, Naim ;
Caputo, Ronald ;
Lansky, Alexandra J. ;
Cutlip, Donald E. ;
Sudhir, Krishnankutty ;
Stone, Gregg W. .
AMERICAN JOURNAL OF CARDIOLOGY, 2011, 107 (06) :833-840
[4]   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 [J].
Bangalore, Sripal ;
Kumar, Sunil ;
Fusaro, Mario ;
Amoroso, Nicholas ;
Attubato, Michael J. ;
Feit, Frederick ;
Bhatt, Deepak L. ;
Slater, James .
CIRCULATION, 2012, 125 (23) :2873-+
[5]  
Basalus M W., 2012, Interv Cardiol, V4, P661
[6]   Coating irregularities of durable polymer-based drug-eluting stents as assessed by scanning electron microscopy [J].
Basalus, Mounir W. Z. ;
Ankone, Marc J. K. ;
van Houwelingen, K. Gert ;
de Man, Frits H. A. F. ;
von Birgelen, Clemens .
EUROINTERVENTION, 2009, 5 (01) :157-165
[7]   Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents:: The TAXi-LATE trial [J].
Berger, Alexandre ;
Stauffer, Jean-Christophe ;
Seydoux, Charles ;
Siegenthaler, Manon ;
Benoit, Alain ;
Goy, Jean-Jacques .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2007, 70 (02) :163-166
[8]   Sirolimus- Versus Paclitaxel-Eluting Stents for the Treatment of Coronary Bifurcations Results From the COBIS (Coronary Bifurcation Stenting) Registry [J].
Bin Song, Young ;
Hahn, Joo-Yong ;
Choi, Seung-Hyuk ;
Choi, Jin-Ho ;
Lee, Sang Hoon ;
Jeong, Myung-Ho ;
Kim, Hyo-Soo ;
Seong, In-Whan ;
Yang, Ju-Young ;
Rha, Seung Woon ;
Jang, Yangsoo ;
Yoon, Jung Han ;
Tahk, Seung-Jea ;
Seung, Ki Bae ;
Park, Seung-Jung ;
Gwon, Hyeon-Cheol .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2010, 55 (16) :1742-1749
[9]   Novel Approaches for Preventing or Limiting Events in Diabetic Patients (Naples-Diabetes) Trial A Randomized Comparison of 3 Drug-Eluting Stents in Diabetic Patients [J].
Briguori, Carlo ;
Airoldi, Flavio ;
Visconti, Gabriella ;
Focaccio, Amelia ;
Caiazzo, Gianluca ;
Golia, Bruno ;
Biondi-Zoccai, Giuseppe ;
Ricciardelli, Bruno ;
Condorelli, Gerolama .
CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (02) :121-129
[10]   Prospective Randomized Comparison of Sirolimus- or Everolimus-Eluting Stent to Treat Bifurcated Lesions by Provisional Approach [J].
Burzotta, Francesco ;
Trani, Carlo ;
Todaro, Daniel ;
Mariani, Luca ;
Talarico, Giovanni Paolo ;
Tommasino, Antonella ;
Giammarinaro, Maura ;
Niccoli, Giampaolo ;
Porto, Italo ;
Leone, Antonio Maria ;
Mongiardo, Rocco ;
Mazzari, Mario Attilio ;
Schiavoni, Giovanni ;
Crea, Filippo .
JACC-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (03) :327-335