Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study)
Elisabetta Moscarella MD
Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi,” Azienda Ospedaliera Dei Colli, Napoli, Italy
Moscarella and Tanaka contributed equally to this study and are joint first authors.
Search for more papers by this authorAkihito Tanaka MD
Department of Interventional Cardiology, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy
Moscarella and Tanaka contributed equally to this study and are joint first authors.
Search for more papers by this authorAlfonso Ielasi MD
Cardiology Division, Ospedale Bolognini Seriate, ASST Bergamo Est, Italy
Search for more papers by this authorBernardo Cortese MD
Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy
Fondazione Monasterio CNR-Regione Toscana, Italy
Search for more papers by this authorSebastian Coscarelli MD
Department of Cardiovascular Intervention, San Martino Hospital, Belluno, Italy
Search for more papers by this authorMaria Carmen De Angelis MD
Department of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy
Search for more papers by this authorDavide Piraino MD
Interventional Cardiology Unit, University of Palermo, Palermo, Italy
Search for more papers by this authorAzeem Latib MD
Department of Interventional Cardiology, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy
Search for more papers by this authorGiulietta Grigis MD
Cardiology Division, Ospedale Bolognini Seriate, ASST Bergamo Est, Italy
Search for more papers by this authorRenatomaria Bianchi MD
Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi,” Azienda Ospedaliera Dei Colli, Napoli, Italy
Search for more papers by this authorDario Buccheri MD
Interventional Cardiology Unit, University of Palermo, Palermo, Italy
Search for more papers by this authorPaolo Calabrò MD, PhD
Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi,” Azienda Ospedaliera Dei Colli, Napoli, Italy
Search for more papers by this authorMaurizio Tespili MD
Cardiology Division, Ospedale Bolognini Seriate, ASST Bergamo Est, Italy
Search for more papers by this authorPedro Silva Orrego MD
Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy
Search for more papers by this authorAntonio Colombo MD
Department of Interventional Cardiology, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy
Search for more papers by this authorCorresponding Author
Attilio Varricchio MD, PhD
Department of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy
Correspondence Attilio Varricchio, MD, PhD, Ospedale Santa Maria della Pietà, 80035 Nola, Naples, Italy. Email: [email protected]Search for more papers by this authorElisabetta Moscarella MD
Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi,” Azienda Ospedaliera Dei Colli, Napoli, Italy
Moscarella and Tanaka contributed equally to this study and are joint first authors.
Search for more papers by this authorAkihito Tanaka MD
Department of Interventional Cardiology, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy
Moscarella and Tanaka contributed equally to this study and are joint first authors.
Search for more papers by this authorAlfonso Ielasi MD
Cardiology Division, Ospedale Bolognini Seriate, ASST Bergamo Est, Italy
Search for more papers by this authorBernardo Cortese MD
Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy
Fondazione Monasterio CNR-Regione Toscana, Italy
Search for more papers by this authorSebastian Coscarelli MD
Department of Cardiovascular Intervention, San Martino Hospital, Belluno, Italy
Search for more papers by this authorMaria Carmen De Angelis MD
Department of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy
Search for more papers by this authorDavide Piraino MD
Interventional Cardiology Unit, University of Palermo, Palermo, Italy
Search for more papers by this authorAzeem Latib MD
Department of Interventional Cardiology, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy
Search for more papers by this authorGiulietta Grigis MD
Cardiology Division, Ospedale Bolognini Seriate, ASST Bergamo Est, Italy
Search for more papers by this authorRenatomaria Bianchi MD
Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi,” Azienda Ospedaliera Dei Colli, Napoli, Italy
Search for more papers by this authorDario Buccheri MD
Interventional Cardiology Unit, University of Palermo, Palermo, Italy
Search for more papers by this authorPaolo Calabrò MD, PhD
Department of Cardio-Thoracic Science, Second University of Naples, Presidio Ospedaliero “Monaldi,” Azienda Ospedaliera Dei Colli, Napoli, Italy
Search for more papers by this authorMaurizio Tespili MD
Cardiology Division, Ospedale Bolognini Seriate, ASST Bergamo Est, Italy
Search for more papers by this authorPedro Silva Orrego MD
Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy
Search for more papers by this authorAntonio Colombo MD
Department of Interventional Cardiology, EMO-GVM Centro Cuore Columbus ed Ospedale San Raffaele, Milano, Italy
Search for more papers by this authorCorresponding Author
Attilio Varricchio MD, PhD
Department of Invasive Cardiology, Santa Maria della Pietà Hospital, Nola, Napoli, Italy
Correspondence Attilio Varricchio, MD, PhD, Ospedale Santa Maria della Pietà, 80035 Nola, Naples, Italy. Email: [email protected]Search for more papers by this authorAbstract
Objectives
to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment.
Background
BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking.
Methods
We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES.
Results
At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33–2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16–18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27–2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27–21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63–5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29–27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47–5.23, P = 0.46; TV-MI: 3.1 vs. 0%).
Conclusion
At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.
Conflict of interest
None
Supporting Information
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Supporting Information Tables |
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REFERENCES
- 1 Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010; 56: 1897–1907.
- 2 Alfonso F, Byrne RA, Rivero F, Kastrati A. Current treatment of in-stent restenosis. J Am Coll Cardiol 2014; 63: 2659–2673.
- 3 Latib A, Mussardo M, Ielasi A, Tarsia G, Godino C, Al-Lamee R, Chieffo A, Airoldi F, Carlino M, Montorfano M, Colombo A. Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosis. J Am Coll Cardiol Cardiovasc Interv 2011; 4: 155–164.
- 4 Steinberg DH, Gaglia MA Jr, Pinto Slottow TL, Roy P, Bonello L, De Labriolle A, Lemesle G, Torguson R, Kineshige K, Xue Z, Suddath WO, Kent KM, Satler LF, Pichard AD, Lindsay J, Waksman R. 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 2009; 103: 491–495.
- 5 Byrne RA, Cassese S, Windisch T, King LA, Joner M, Tada T, Mehilli J, Pache J, Kastrati A. 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 2013; 9: 797–802.
- 6 Ielasi A, Latib A, Naganuma T, Cortese B, Sato K, Miyazaki T, Panoulas VF, Tespili M, Colombo A. Early results following everolimus-eluting bioresorbable vascular scaffold implantation for the treatment of in-stent restenosis. Int J Cardiol 2014; 173: 513–514.
- 7 Moscarella E, Varricchio A, Stabile E, Latib A, Ielasi A, Tespili M, Cortese B, Calabrò P, Granata F, Panoulas VF, Franzone A, Trimarco B, Bonzani G, Esposito G, Colombo A. Bioresorbable vascular scaffold implantation for the treatment of coronary in-stent restenosis: Results From a Multicenter Italian Experience. Int J Cardiol 2015; 199: 366–372.
- 8 Moscarella E, Ielasi A, Granata F, Coscarelli S, Stabile E, Latib A, Cortese B, Tespili M, Tanaka A, Capozzolo C, Caliendo L, Colombo A, Varricchio A. Long-Term clinical outcomes after bioresorbable vascular scaffold implantation for the treatment of coronary in-stent restenosis: A multicenter Italian experience. Circ Cardiovasc Interv 2016; 9: e003148.
- 9 Mehran R, Dangas G, Abizaid A, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: Classification and implications for long-term outcome. Circulation 1999; 100: 1872–1878.
- 10 Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007; 115: 2344–2351.
- 11 Reiber JH, Serruys PJ. Quantitative coronary angiography: Methodologies. Quantitative coronary angiography. Dordrecht, The Netherlands: Kluwer Academic Publishers; 1996. pp 9 8–102.
- 12 Rosenbaum PR, Rubin DB. Constructing a control group using multivariate matched sampling methods that incorporate the propensity score. Am Stat 1985; 39: 33–38.
- 13 Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res 2011; 46: 399–424.
- 14 Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 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 2014; 35: 2541–2619.
- 15 Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. 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 2013; 381: 461–467.
- 16 Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wöhrle J. 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 2012; 59: 1377–1382.
- 17 Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García del Blanco B, García-Touchard A, López-Minguéz JR, Benedicto A, Masotti M, Zueco J, Iñiguez A, Velázquez M, Moreno R, Mainar V, Domínguez A, Pomar F, Melgares R, Rivero F, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C; RIBS IV Study Investigators (under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology). 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. J Am Coll Cardiol 2015; 66: 23–33.
- 18 Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, Seidelberger B, Iñiguez A, Gómez-Recio M, Masotti M, Velázquez MT, Sanchís J, García-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, López-Mínguez JR, Moreu J, Martí V, Moreno R, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C; RIBS V Study Investigators. Under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. 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 (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol 2014; 63: 1378–1386.
- 19 Alfonso F, Cuesta J, Pérez-Vizcayno MJ, García Del Blanco B, Rumoroso JR, Bosa F, Pérez de Prado A, Masotti M, Moreno R, Cequier A, Gutiérrez H, García Touchard A, López-Mínguez JR, Zueco J, Martí V, Velázquez M, Morís C, Bastante T, García-Guimaraes M, Rivero F, Fernández C; Interventional Cardiology Working Group of the Spanish Society of Cardiology. Bioresorbable Vascular Scaffolds for Patients With In-Stent Restenosis: The RIBS VI Study. JACC Cardiovasc Interv 2017; 10: 1841–1851.
- 20 Ortega-Paz L, Capodanno D, Gori T, Nef H, Latib A, Caramanno G, Di Mario C, Naber C, Lesiak M, Capranzano P, Wiebe J, Mehilli J, Araszkiewicz A, Pyxaras S, Mattesini A, Geraci S, Naganuma T, Colombo A, Münzel T, Sabaté M, Tamburino C, Brugaletta S. Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score. EuroIntervention 2017; 12: 2110–2117.
- 21 Ielasi A, Cortese B, Moscarella E, Loi B, Tarantini G, Varricchio A, Pisano F, Durante A, Pasquetto G, Colombo A, Tumminello G, Moretti L, Calabrò P, Mazzarotto P, Tespili M, Corrado D, Steffenino G. One-year clinical outcomes after unrestricted implantation of absorb bioresorbable scaffold (RAI Registry). EuroIntervention. 2017. pii: EIJ-D-17-00443.
- 22 Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Münzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: Early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention 2015; 10: 1144–1153.
- 23 Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJsselmuiden AJ, Elias J, van Dongen IM, Tijssen RYG, Koch KT, Baan J, Vis MM, de Winter RJ, Piek JJ, Tijssen JGP, Henriques JPS; AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med 2017; 376: 2319–2328.
- 24 Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrié D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iñiguez A, Sabaté M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): A 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 2016; 388: 2479–2491.
- 25 Kereiakes D, Ellis SJ, Metzger C, Caputo RP, Rizik DG, et al. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. 2017;70:2852–2862.
- 26 Ali ZA, Serruys PW, Kimura T, Gao R, Ellis SG, Kereiakes DJ, Onuma Y, Simonton C, Zhang Z, Stone GW. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: A systematic review and meta-analysis of seven randomized trials with an individual patient data substudy. Lancet 2017; 390: 760–772.
- 27 Stone GW, Abizaid A, Onuma Y, Seth A, Gao R, Ormiston J, Kimura T, Chevalier B, Ben-Yehuda O, Dressler O, McAndrew T, Ellis SG, Kereiakes DJ, Serruys PW. Effect of technique on outcomes following bioresorbable vascular scaffold implantation analysis from the ABSORB Trials. J Am Coll Cardiol 2017; 70: 2863–2874.
