Clinical Outcomes of the Resolute Zotarolimus-Eluting Stent in Patients With In-Stent Restenosis

被引:19
作者
Richardt, Gert [1 ]
Leschke, Matthias [2 ]
Abdel-Wahab, Mohamed [1 ]
Toelg, Ralph [1 ]
El-Mawardy, Mohamed [1 ]
Serruys, Patrick W. [3 ]
Silber, Sigmund [4 ]
Windecker, Stephan [5 ]
Belardi, Jorge A. [6 ]
Neumann, Franz-Josef [7 ]
Widimsky, Petr [8 ]
机构
[1] Segeberger Kliniken GmbH, Herzzentrum, D-23795 Bad Segeberg, Germany
[2] Kliniken Esslingen, Esslingen Am Neckar, Germany
[3] Erasmus MC, Thoraxctr, Rotterdam, Netherlands
[4] Heart Ctr Isar, Munich, Germany
[5] Univ Hosp Bern, Dept Cardiol, CH-3010 Bern, Switzerland
[6] Cardiovasc Inst Buenos Aires, Buenos Aires, DF, Argentina
[7] Heart Ctr Bad Krozingen, Bad Krozingen, Germany
[8] Charles Univ Prague, Cardioctr Kralovske Vinohrady, Prague, Czech Republic
关键词
clinical outcome; in-stent restenosis; PCI; zotarolimus-eluting stent; BARE-METAL STENTS; TARGET VESSEL REVASCULARIZATION; 2-YEAR FOLLOW-UP; BALLOON ANGIOPLASTY; VASCULAR BRACHYTHERAPY; MULTICENTER; TRIAL; ANGIOGRAPHY; PREDICTORS; LESIONS;
D O I
10.1016/j.jcin.2013.04.017
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials. Background ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR. Methods A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST). Results Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively. Conclusions Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128) (C) 2013 by the American College of Cardiology Foundation
引用
收藏
页码:905 / 913
页数:9
相关论文
共 30 条
[1]   Clinical outcome of percutaneous treatment of in-stent restenosis with drug-eluting stents: results from the first phase of the prospective multicentre German DES.DE registry [J].
Abdel-Wahab, Mohamed ;
Nienaber, Christoph A. ;
Mostafa, Ahmad E. ;
Sabin, Georg ;
Tebbe, Ulrich ;
Hochadel, Matthias ;
Senges, Jochen ;
Akin, Ibrahim ;
Kuck, Karl-Heinz ;
Hamm, Christian ;
Richardt, Gert .
EUROINTERVENTION, 2011, 7 (02) :201-208
[2]   A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis -: Results of the restenosis intrastent:: Balloon angioplasty versus elective sirolimus-eluting stenting (RIBS-II) trial [J].
Alfonso, Fernando ;
Perez-Vizcayno, Maria-Jose ;
Hernandez, Rosana ;
Bethencourt, Armando ;
Marti, Vicens ;
Lopez-Minguez, Jose R. ;
Angel, Juan ;
Mantilla, Ramon ;
Moris, Cesar ;
Cequier, Angel ;
Sabate, Manel ;
Escaned, Javier ;
Moreno, Raul ;
Bañuelos, Camino ;
Suarez, Alfonso ;
Macaya, Carlos .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2006, 47 (11) :2152-2160
[3]  
Hehrlein C, 2011, EUROINTERVENTION, V7, pK119, DOI 10.4244/EIJV7SKA20
[4]   Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents - The SISR randomized trial [J].
Holmes, DR ;
Teirstein, P ;
Satler, L ;
Sketch, M ;
O'Malley, J ;
Popma, JJ ;
Kuntz, RE ;
Fitzgerald, PJ ;
Wang, H ;
Caramanica, E ;
Cohen, SA .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2006, 295 (11) :1264-1273
[5]   Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis -: A randomized controlled trial [J].
Kastrati, A ;
Mehilli, J ;
von Beckerath, N ;
Dibra, A ;
Hausleiter, J ;
Pache, J ;
Schühlen, H ;
Schmitt, C ;
Dirschinger, J ;
Schömig, A .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2005, 293 (02) :165-171
[6]   Incidence and predictors of target vessel revascularization after sirolimus-eluting stent treatment for proximal left anterior descending artery stenoses among 2274 patients from the prospective multicenter German Cypher Stent Registry [J].
Khattab, A. A. ;
Hamm, C. W. ;
Senges, J. ;
Toelg, R. ;
Geist, V. ;
Bonzel, T. ;
Kelm, M. ;
Levenson, B. ;
Nienaber, C. A. ;
Sabin, G. ;
Tebbe, U. ;
Schneider, S. ;
Richardt, G. .
CLINICAL RESEARCH IN CARDIOLOGY, 2007, 96 (05) :279-284
[7]   Vascular responses to the multiple overlapped paclitaxel- eluting stents for the treatment of bare- metal in- stent restenotic lesions: angiographic and intravascular ultrasound analysis from the TAXUS-V ISR Trial [J].
Koizumi, Tomomi ;
Fitzgerald, Peter J. ;
Honda, Yasuhiro ;
Ellis, Stephen G. ;
Kent, Kenneth ;
Martin, Steven L. ;
Brown, Charles L. ;
Masud, A. R. Zaki ;
Patterson, John B. ;
Greenberg, Joel ;
Friedman, Mark ;
Uchida, Takahiro ;
Stone, Gregg W. .
CARDIOVASCULAR REVASCULARIZATION MEDICINE, 2010, 11 (03) :140-148
[8]   2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions [J].
Levine, Glenn N. ;
Bates, Eric R. ;
Blankenship, James C. ;
Bailey, Steven R. ;
Bittl, John A. ;
Cercek, Bojan ;
Chambers, Charles E. ;
Ellis, Stephen G. ;
Guyton, Robert A. ;
Hollenberg, Steven M. ;
Khot, Umesh N. ;
Lange, Richard A. ;
Mauri, Laura ;
Mehran, Roxana ;
Moussa, Issam D. ;
Mukherjee, Debabrata ;
Nallamothu, Brahmajee K. ;
Ting, Henry H. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2011, 58 (24) :E44-E122
[9]   Drug-Eluting Stents vs Intracoronary Brachytherapy for In-Stent Restenosis: A Meta-Analysis [J].
Lu, Yong-Guang ;
Chen, Yan-Mei ;
Li, Lang ;
Zhao, Rong-Zhen ;
Fu, Chun-Hui ;
Yan, Hua .
CLINICAL CARDIOLOGY, 2011, 34 (06) :344-351
[10]   Randomized Trial of Paclitaxel-Versus Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents The ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) Study [J].
Mehilli, Julinda ;
Byrne, Robert A. ;
Tiroch, Klaus ;
Pinieck, Susanne ;
Schulz, Stefanie ;
Kufner, Sebastian ;
Massberg, Steffen ;
Laugwitz, Karl-Ludwig ;
Schoemig, Albert ;
Kastrati, Adnan .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2010, 55 (24) :2710-2716