Absorb Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Metallic Stent in ST-Segment Elevation Myocardial Infarction: 1-Year Results of a Propensity Score Matching Comparison The BVS-EXAMINATION Study (Bioresorbable Vascular Scaffold-A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction)

被引:149
作者
Brugaletta, Salvatore [1 ]
Gori, Tommaso [2 ]
Low, Adrian F. [3 ]
Tousek, Petr [4 ]
Pinar, Eduardo [5 ]
Gomez-Lara, Josep [6 ]
Scalone, Giancarla [1 ]
Schulz, Eberhard [2 ]
Chan, Mark Y. [3 ]
Kocka, Viktor [4 ]
Hurtado, Jose [5 ]
Gomez-Hospital, Juan Antoni [6 ]
Muenzel, Thomas [2 ]
Lee, Chi-Hang [3 ]
Cequier, Angel [6 ]
Valdes, Mariano [5 ]
Widimsky, Petr [4 ]
Serruys, Patrick W. [7 ]
Sabate, Manel [1 ]
机构
[1] Univ Barcelona, Hosp Clin Barcelona, Thorax Inst, Inst dInvest Biomed August Pi Sunyer, Barcelona, Spain
[2] Med Klin & Poliklin Kardiol Angiol & Innere Inten, Mainz, Germany
[3] Natl Univ Hlth Syst, Natl Univ Heart Ctr Singapore, Dept Cardiac, Singapore, Singapore
[4] Charles Univ Prague, Univ Hosp Kralovske Vinohrady, Cardio Ctr, Prague, Czech Republic
[5] Virgen Arrixaca Hosp, Dept Cardiol, Intervent Cardiol Unit, Murcia, Spain
[6] Bellvitge Hosp, Inst Cardiol, Barcelona, Spain
[7] Erasmus Univ, Med Ctr, Thoraxctr, Rotterdam, Netherlands
关键词
ABSORB; everolimus-eluting stent; STEMI; BIODEGRADABLE POLYMER; ARTERY-DISEASE; TRIAL; OUTCOMES; SYSTEM; IMPLANTATION; METAANALYSIS; THROMBOSIS; RATIONALE; DESIGN;
D O I
10.1016/j.jcin.2014.10.005
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVES The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients. BACKGROUND The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients. METHODS This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated. RESULTS The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS. CONCLUSIONS At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings. (C) 2015 by the American College of Cardiology Foundation.
引用
收藏
页码:189 / 197
页数:9
相关论文
共 26 条
[1]  
[Anonymous], EUROINTERVENTION
[2]   A comparison of propensity score methods: A case-study estimating the effectiveness of post-AMI statin use [J].
Austin, PC ;
Mamdani, MM .
STATISTICS IN MEDICINE, 2006, 25 (12) :2084-2106
[3]   Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis [J].
Bangalore, Sripal ;
Toklu, Bora ;
Amoroso, Nicholas ;
Fusaro, Mario ;
Kumar, Sunil ;
Hannan, Edward L. ;
Faxon, David P. ;
Feit, Frederick .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 347
[4]  
Brugaletta S, 2012, EXPERT REV MED DEVIC, V9, P327, DOI [10.1586/erd.12.17, 10.1586/ERD.12.17]
[5]   Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: Can the scaffold cap the plaque? [J].
Brugaletta, Salvatore ;
Radu, Maria D. ;
Garcia-Garcia, Hector M. ;
Heo, Jung Ho ;
Farooq, Vasim ;
Girasis, Chrysafios ;
van Geuns, Robert-Jan ;
Thuesen, Leif ;
McClean, Dougal ;
Chevalier, Bernard ;
Windecker, Stephan ;
Koolen, Jacques ;
Rapoza, Richard ;
Miquel-Hebert, Karine ;
Ormiston, John ;
Serruys, Patrick W. .
ATHEROSCLEROSIS, 2012, 221 (01) :106-112
[6]   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
[7]   Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study [J].
Diletti, Roberto ;
Karanasos, Antonios ;
Muramatsu, Takashi ;
Nakatani, Shimpei ;
Van Mieghem, Nicolas M. ;
Onuma, Yoshinobu ;
Nauta, Sjoerd T. ;
Ishibashi, Yuki ;
Lenzen, Mattie J. ;
Schultz, Carl ;
Regar, Evelyn ;
de Jaegere, Peter P. ;
Serruys, Patrick W. ;
Zijlstra, Felix ;
van Geuns, Robert Jan .
EUROPEAN HEART JOURNAL, 2014, 35 (12) :777-+
[8]   ABSORB II randomized controlled trial. A clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: Rationale and study design [J].
Diletti, Roberto ;
Serruys, Patrick W. ;
Farooq, Vasim ;
Sudhir, Krishnankutty ;
Dorange, Cecile ;
Miquel-Hebert, Karine ;
Veldhof, Susan ;
Rapoza, Richard ;
Onuma, Yoshinobu ;
Garcia-Garcia, Hector M. ;
Chevalier, Bernard .
AMERICAN HEART JOURNAL, 2012, 164 (05) :654-663
[9]   Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial [J].
Dudek, Dariusz ;
Onuma, Yoshinobu ;
Ormiston, John A. ;
Thuesen, Leif ;
Miquel-Hebert, Karine ;
Serruys, Patrick W. .
EUROINTERVENTION, 2012, 7 (09) :1060-1061
[10]   Acute Absorb bioresorbable vascular scaffold thrombosis in ST-segment elevation myocardial infarction: to stent or not to stent? [J].
Fernandez-Rodriguez, Diego ;
Brugaletta, Salvatore ;
Otsuki, Shuji ;
Sabate, Manel .
EUROINTERVENTION, 2014, 10 (05) :600-600