A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis of Drug-Eluting Stents the RIBS IV Randomized Clinical Trial

Journal of the American College of Cardiology

Volumn 66, Issue 1, 2015, Pages 23-33

  Alfonso, Fernando ^a   Pérez Vizcayno, María Jose ^b   Cárdenas, Alberto ^b   García Del Blanco, Bruno ^c   García Touchard, Arturo ^d   López Minguéz, José Ramón ^e   Benedicto, Amparo ^a   Masotti, Mónica ^f   Zueco, Javier ^g   Iñiguez, Andrés ^h   Velázquez, Maite ⁱ   Moreno, Raúl ^j   Mainar, Vicente ^k   Domínguez, Antonio ^l   Pomar, Francisco ^m   Melgares, Rafael ⁿ   Rivero, Fernando ^a   Jiménez Quevedo, Pilar ^b   Gonzalo, Nieves ^b   Fernández, Cristina ^b   Macaya, Carlos ^b   more..

^a HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^b HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^e HOSPITAL INFANTA CRISTINA   (Spain)

^f HOSPITAL CLÍNIC   (Spain)

^g HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^h Meixoeiro Hospital   (Spain)

ⁱ HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^j HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^k HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

^l HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^m HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA   (Spain)

ⁿ HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

more..

Author keywords

angiography; percutaneous coronary intervention; proliferation; revascularization

Indexed keywords

AGED; ARTICLE; BALLOON CATHETER; CARDIOGENIC SHOCK; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; CORONARY ARTERY RECANALIZATION; CROSSOVER PROCEDURE; DEVICE SAFETY; DRUG ELUTING BALLOON; DRUG ELUTING STENT; EVEROLIMUS ELUTING CORONARY STENT; FEMALE; HEART DEATH; HEART INFARCTION; HUMAN; IN-STENT RESTENOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SPAIN; STENT THROMBOSIS; TARGET LESION REVASCULARIZATION; TARGET VESSEL REVASCULARIZATION; THORAX PAIN; TREATMENT OUTCOME; UNIVERSITY HOSPITAL; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMPARATIVE STUDY; CORONARY RESTENOSIS; MIDDLE AGED; TRANSLUMINAL CORONARY ANGIOPLASTY;

EVEROLIMUS; IMMUNOSUPPRESSIVE AGENT; RAPAMYCIN;

AGED; ANGIOPLASTY, BALLOON, CORONARY; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SIROLIMUS;

EID: 84937399147     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2015.04.063     Document Type: Article

References (32)

1. G.G. Stefanini, and D.R. Holmes Jr. Drug-eluting coronary-artery stents N Engl J Med 368 2013 254 265
2. B. García del Blanco, F. Hernández-Hernández, J.R. Rumoroso-Cuevas, and R. Trillo-Nouche Spanish Cardiac Catheterization and Coronary Intervention Registry. 23rd Official report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2013) Rev Esp Cardiol 67 2014 1013 1023
3. F. Alfonso, R.A. Byrne, F. Rivero, and A. Kastrati Current treatment of in-stent restenosis J Am Coll Cardiol 63 2014 2659 2673
4. G.D. Dangas, B.E. Claessen, A. Caixeta, E.A. Sanidas, G.S. Mintz, and R. Mehran In-stent restenosis in the drug-eluting stent era J Am Coll Cardiol 56 2010 1897 1907
5. D.H. Steinberg, M.A. Gaglia Jr., T.L. Pinto Slottow, and et al. Outcome differences with the use of drug-eluting stents for the treatment of in-stent restenosis of bare-metal stents versus drug-eluting stents Am J Cardiol 103 2009 491 495
6. R.A. Byrne, S. Cassese, T. Windisch, and et al. Differential relative efficacy between drug-eluting stents in patients with bare metal and drug-eluting stent restenosis; evidence in support of drug resistance: insights from the ISAR-DESIRE and ISAR-DESIRE 2 trials EuroIntervention 9 2013 797 802
7. F. Alfonso, J. Zueco, A. Cequier, and et al. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis J Am Coll Cardiol 42 2003 796 805
8. F. Alfonso, M.J. Pérez-Vizcayno, R. Hernandez, and et al. 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 Am Coll Cardiol 47 2006 2152 2160
9. A. Kastrati, J. Mehilli, N. von Beckerath, and et al. 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 JAMA 293 2005 165 171
10. J. Mehilli, R.A. Byrne, K. Tiroch, and et al. 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 Am Coll Cardiol 55 2010 2710 2716
11. B. Scheller, C. Hehrlein, W. Bocksch, and et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter N Engl J Med 355 2006 2113 2124
12. M. Unverdorben, C. Vallbracht, B. Cremers, and et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis Circulation 119 2009 2986 2994
13. S. Habara, K. Mitsudo, K. Kadota, and et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis J Am Coll Cardiol Intv 4 2011 149 154
14. H. Rittger, J. Brachmann, A.M. Sinha, and et al. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study J Am Coll Cardiol 59 2012 1377 1382
15. S. Habara, M. Iwabuchi, N. Inoue, and et al. A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis Am Heart J 166 2013 527 533
16. B. Xu, R. Gao, J. Wang, and et al. PEPCAD China ISR. A prospective, multicentre, randomized trial, of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of in-stent restenosis J Am Coll Cardiol Intv 7 2014 204 211
17. R.A. Byrne, F.J. Neumann, J. Mehilli, and et al. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial Lancet 381 2013 461 467
18. F. Alfonso, M.J. Pérez-Vizcayno, A. Cárdenas, and et al. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent in-stent restenosis: the RIBS V clinical trial J Am Coll Cardiol 63 2014 1378 1386
19. T. Palmerini, G. Biondi-Zoccai, D. Della Riva, and et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis Lancet 379 2012 1393 1402
20. F. Alfonso, and C. Fernandez Second-generation drug-eluting stents: moving the field forward J Am Coll Cardiol 58 2011 26 29
21. F. Alfonso, M.J. Pérez-Vizcayno, J. Dutary, and et al. Implantation of a drug-eluting stent with a different drug (switch strategy) in patients with drug-eluting stent restenosis: results from a prospective multicenter study (RIBS III [Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent]) J Am Coll Cardiol Intv 5 2012 728 737
22. F. Alfonso, M.J. Pérez-Vizcayno, A. Cárdenas, and et al. Rationale and design of the RIBS IV randomised clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis) EuroIntervention 2014 Sep 22 [E-pub ahead of print]
23. D.E. Cutlip, S. Windecker, R. Mehran, and et al. Clinical end-points in coronary stent trials: a case for standardized definitions Circulation 115 2007 2344 2351
24. R. Mehran, G. Dangas, A.S. Abizaid, and et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome Circulation 100 1999 1872 1878
25. F. Alfonso, A. Cequier, J. Angel, and et al. Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis Am Heart J 151 2006 681.e1 681.e9
26. F. Alfonso, P. García, H. Fleites, and et al. Repeat stenting for the prevention of the early lumen loss phenomenon in patients with in-stent restenosis: angiographic and intravascular ultrasound findings of a randomized study Am Heart J 149 2005 e1 e8
27. G. Nakazawa, F. Otsuka, M. Nakano, and et al. The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents J Am Coll Cardiol 57 2011 1314 1322
28. F. Otsuka, M. Vorpahl, M. Nakano, and et al. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans Circulation 129 2014 211 223
29. R.E. Kuntz, R.D. Safian, M.J. Levine, G.J. Reis, D.J. Diver, and D.S. Baim Novel approach to the analysis of restenosis after the use of three new coronary devices J Am Coll Cardiol 19 1992 1493 1499
30. S. Windecker, P. Kolh, F. Alfonso, and et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur Heart J 35 2014 2541 2619
31. T. Adriaenssens, J. Dens, G. Ughi, and et al. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug Eluting Balloon in Coronary Artery Restenosis) randomised clinical trial EuroIntervention 10 2014 439 448
32. J. Wöhrle, M. Zadura, S. Möbius-Winkler, and et al. SeQuentPlease world wide registry: clinical results of SeQuent Please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study J Am Coll Cardiol 60 2012 1733 1738