Self-Expanding Versus Balloon-Expandable Stents in Acute Myocardial Infarction: Results From the APPOSITION II Study Self-Expanding Stents in ST-Segment Elevation Myocardial Infarction

被引:75
作者
van Geuns, Robert-Jan [2 ]
Tamburino, Corrado [3 ]
Fajadet, Jean [4 ]
Vrolix, Mathias [5 ]
Witzenbichler, Bernhard [6 ]
Eeckhout, Eric [7 ]
Spaulding, Christian [8 ,9 ]
Reczuch, Krzysztof [10 ,11 ]
La Manna, Alessio [3 ]
Spaargaren, Rene [12 ]
Garcia-Garcia, Hector M. [13 ]
Regar, Evelyn [2 ]
Capodanno, Davide [3 ]
Van Langenhove, Glenn [1 ]
Verheye, Stefan [1 ]
机构
[1] ZNA Middelheim, Antwerp Cardiovasc Ctr, Dept Cardiol, B-2020 Antwerp, Belgium
[2] Erasmus MC, Thoraxctr, Rotterdam, Netherlands
[3] Univ Catania, Ferrarotto Hosp, Div Cardiol, Catania, Italy
[4] Clin Pasteur, Dept Intervent Cardiol, Toulouse, France
[5] Ziekenhuis Oost Limburg, Dept Cardiol, Genk, Belgium
[6] Dept Cardiol, Berlin, Germany
[7] CHU Vaudois, Serv Cardiol, CH-1011 Lausanne, Switzerland
[8] Paris Descartes Univ, AP HP, Hop Europeen Georges Pompidou, Paris, France
[9] INSERM, Unite 970, Paris, France
[10] Mil Hosp, Wroclaw, Poland
[11] Med Univ, Wroclaw, Poland
[12] STENTYS SA, Paris, France
[13] Cardialysis, Rotterdam, Netherlands
关键词
acute myocardial infarction; clinical trial information; nitinol; optical coherence tomography; percutaneous coronary intervention; self-expanding stents; OPTICAL COHERENCE TOMOGRAPHY; DRUG-ELUTING STENTS; CORONARY STENT; THROMBOLYTIC THERAPY; PRIMARY ANGIOPLASTY; THROMBOSIS; PREDICTORS; OUTCOMES; REVASCULARIZATION; IMPLANTATION;
D O I
10.1016/j.jcin.2012.08.016
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives This study sought to investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 3 days after implantation in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Background Acute myocardial infarction is associated with vasoconstriction and large thrombus burden. Resolution of vasoconstriction and thrombus load during the first hours to days after primary percutaneous coronary intervention may lead to stent undersizing and malapposition, which may subsequently lead to stent thrombosis or restenosis. In addition, aggressive stent deployment may cause distal embolization. Methods Eighty patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomized to receive a self-expanding stent (STENTYS, STENTYS SA, Paris, France) (n = 43) or a balloon-expandable stent (VISION, Abbott Vascular, Santa Clara, California; or Driver, Medtronic, Minneapolis, Minnesota) (n = 37) at 9 European centers. The primary endpoint was the proportion of stent strut malapposition at 3 days after implantation measured by optical coherence tomography. Secondary endpoints included major adverse cardiac events (cardiac death, recurrent myocardial infarction, emergent bypass surgery, or clinically driven target lesion revascularization). Results At 3 days after implantation, on a per-strut basis, a lower rate of malapposed stent struts was observed by optical coherence tomography in the self-expanding stent group than in the balloon-expandable group (0.58% vs. 5.46%, p < 0.001). On a per-patient basis, none of the patients in the self-expanding stent group versus 28% in the balloon-expandable group presented >= 5% malapposed struts (p < 0.001). At 6 months, major adverse cardiac events were 2.3% versus 0% in the self-expanding and balloon-expandable groups, respectively (p = NS). Conclusions Strut malapposition at 3 days is significantly lower in ST-segment elevation myocardial infarction patients allocated to self-expanding stents when than in those allocated to balloon-expandable stents. The impact of this difference on clinical outcome and the risk of late stent thrombosis need to be evaluated further. (Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction [ APPOSITION II]; NCT01008085) (J Am Coll Cardiol Intv 2012;5:1209-19) (C) 2012 by the American College of Cardiology Foundation
引用
收藏
页码:1209 / 1219
页数:11
相关论文
共 26 条
[1]   Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study [J].
Amoroso, Giovanni ;
van Geuns, Robert-Jan ;
Spaulding, Christian ;
Manzo-Silberman, Stephane ;
Hauptmann, Karl E. ;
Spaargaren, Rene ;
Garcia-Garcia, Hector M. ;
Serruys, Patrick W. ;
Verheye, Stefan .
EUROINTERVENTION, 2011, 7 (04) :428-436
[2]   An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study [J].
Barlis, Peter ;
Regar, Evelyn ;
Serruys, Patrick W. ;
Dimopoulos, Konstantinos ;
van der Giessen, Willem J. ;
van Geuns, Robert-Jan M. ;
Ferrante, Giuseppe ;
Wandel, Simon ;
Windecker, Stephan ;
van Es, Gerrit-Anne ;
Eerdmans, Pedro ;
Jueni, Peter ;
di Mario, Carlo .
EUROPEAN HEART JOURNAL, 2010, 31 (02) :165-176
[3]   Intracoronary Optical Coherence Tomography: A Comprehensive Review Clinical and Research Applications [J].
Bezerra, Hiram G. ;
Costa, Marco A. ;
Guagliumi, Giulio ;
Rollins, Andrew M. ;
Simon, Daniel I. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2009, 2 (11) :1035-1046
[4]   Coronary artery stents: identification and evaluation [J].
Butany, J ;
Carmichael, K ;
Leong, SW ;
Collins, MJ .
JOURNAL OF CLINICAL PATHOLOGY, 2005, 58 (08) :795-804
[5]   Predictors of subacute stent thrombosis - Results of a systematic intravascular ultrasound study [J].
Cheneau, E ;
Leborgne, L ;
Mintz, GS ;
Kotani, J ;
Pichard, AD ;
Satler, LF ;
Canos, D ;
Castagna, M ;
Weissman, NJ ;
Waksman, R .
CIRCULATION, 2003, 108 (01) :43-47
[6]   Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation [J].
Cook, Stephane ;
Wenaweser, Peter ;
Togni, Mario ;
Billinger, Michael ;
Morger, Cyrill ;
Seiler, Christian ;
Vogel, Rolf ;
Hess, Otto ;
Meier, Bernhard ;
Windecker, Stephan .
CIRCULATION, 2007, 115 (18) :2426-2434
[7]  
Cutlip DE, 2001, CIRCULATION, V103, P1967
[8]   Reproducibility of quantitative optical coherence tomography for stent analysis [J].
Gonzalo, Nieves ;
Garcia-Garcia, Hector M. ;
Serruys, Patrick W. ;
Commissaris, Koen H. ;
Bezerra, Hiram ;
Gobbens, Pierre ;
Costa, Marco ;
Regar, Evelyn .
EUROINTERVENTION, 2009, 5 (02) :224-232
[9]   Strut Coverage and Late Malapposition With Paclitaxel-Eluting Stents Compared With Bare Metal Stents in Acute Myocardial Infarction Optical Coherence Tomography Substudy of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial [J].
Guagliumi, Giulio ;
Costa, Marco A. ;
Sirbu, Vasile ;
Musumeci, Giuseppe ;
Bezerra, Hiram G. ;
Suzuki, Nobuaki ;
Matiashvili, Aleksandre ;
Lortkipanidze, Nikoloz ;
Mihalcsik, Laurian ;
Trivisonno, Antonio ;
Valsecchi, Orazio ;
Mintz, Gary S. ;
Dressler, Ovidiu ;
Parise, Helen ;
Maehara, Akiko ;
Cristea, Ecaterina ;
Lansky, Alexandra J. ;
Mehran, Roxana ;
Stone, Gregg W. .
CIRCULATION, 2011, 123 (03) :274-281
[10]   Optical Coherence Tomography Assessment of In Vivo Vascular Response After Implantation of Overlapping Bare-Metal and Drug-Eluting Stents [J].
Guagliumi, Giulio ;
Musumeci, Giuseppe ;
Sirbu, Vasile ;
Bezerra, Hiram G. ;
Suzuki, Nobuaki ;
Fiocca, Luigi ;
Matiashvili, Aleksandre ;
Lortkipanidze, Nikoloz ;
Trivisonno, Antonio ;
Valsecchi, Orazio ;
Biondi-Zoccai, Giuseppe ;
Costa, Marco A. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2010, 3 (05) :531-539