Registro prospectivo del stent liberador de sirolimus con polímero estable de fluoroacrilato AngioliteEstudio EPIC02 – RANGO

  1. Armando Pérez de Prado 1
  2. Raymundo Ocaranza 2
  3. Fernando Lozano Ruiz-Poveda 3
  4. José Moreu 4
  5. Raquel Álvarez Ramos 5
  6. Alberto Rodrigues 6
  7. Luis Fernández González 7
  8. Pablo Aguar Carrascosa 8
  9. Bruno García del Blanco 9
  10. Eduardo Pinar Bermúdez 10
  11. Vicente Peral Disdier 11
  12. Fermín Sainz Laso 12
  13. José R. Rumoroso Cuevas 13
  14. Alfonso Torres 14
  15. Manel Sabaté Tenas 15
  16. R. Trillo Nouche 16
  1. 1 Servicio de Cardiología, Hospital Universitario de León, León, España
  2. 2 Servicio de Cardiología, Hospital Lucus Augusti, Lugo, España
  3. 3 Servicio de Cardiología, Hospital General Universitario Ciudad Real, Ciudad Real, España
  4. 4 Servicio de Cardiología, Hospital Virgen de la Salud, Toledo, España
  5. 5 Servicio de Cardiología, Hospital Universitario de La Fe, Valencia, España
  6. 6 Servicio de Cardiología, Hospital de Vila Nova, Gaia, Portugal
  7. 7 Servicio de Cardiología, Hospital Cruces, Bilbao, España
  8. 8 Servicio de Cardiología, Hospital Dr. Peset, Valencia, España
  9. 9 Servicio de Cardiología, Hospital Vall D’Hebron, Barcelona, España
  10. 10 Servicio de Cardiología, Hospital Virgen de la Arrixaca, El Palmar, Murcia, España
  11. 11 Servicio de Cardiología, Hospital Son Espases, Palma de Mallorca, España
  12. 12 Servicio de Cardiología, Hospital Marqués de Valdecilla, Santander, España
  13. 13 Servicio de Cardiología, Hospital Galdakao-Usansolo, Bilbao, España
  14. 14 Servicio de Cardiología, Hospital Universitario de Araba, Vitoria, Álava, España
  15. 15 Servicio de Cardiología, Hospital Clínic, IDIBAPS, Barcelona, España
  16. 16 Servicio de Cardiología, Hospital Universitario de Santiago de Compostela, A Coruña, España
Mostrar afiliacións +
Revista:
REC: Interventional Cardiology

ISSN: 2604-7276,  2604-7306

Ano de publicación: 2021

Volume: 3

Número: 4

Páxinas: 258-266

Tipo: Artigo

DOI: 10.24875/RECIC.M21000219 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

Outras publicacións en: REC: Interventional Cardiology

Resumo

Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospective, multicenter registry of patients with different clinical indications. All consecutive patients treated with percutaneous coronary intervention with, at least, 1 Angiolite stent and who gave their informed consent were included. The registry primary endpoint was the occurrence of target lesion failure (TLF) at 6, 12, and 24 months defined as cardiovascular death, myocardial infarction (MI) related to target vessel, and clinically driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint, major adverse cardiovascular events (MACE: all-cause mortality, any MI, or any revascularization), and stent thrombosis. We describe the 2-year clinical results of the RANGO study in the entire population, in those who only received Angiolite stents, and in 2 predefined subgroups: diabetics and patients with small-vessels ("64; 2.5mm). Results: 646 patients (426 of them only received Angiolite stents) with a high-risk profile were recruited: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). At the 2-year follow-up, the rates of TLF, MACE, and stent thrombosis were 3.4%, 9.6%, and 0.9%, respectively. Similar results were observed among patients treated with Angiolite stents only: TLF, 3.1%; MACE, 8.0%; thrombosis, 0.7%. The rates were not significantly different for the diabetic (TLF, 3.0%; MACE, 14.1%; thrombosis, 1.0%), and small-vessel subgroups (TLF, 4.3%; MACE, 12.1%; thrombosis, 0%). Conclusions: In conclusion, the results of this observational registry on the use of Angiolite in a real-world population, including a high-risk population, corroborate the excellent results observed in previous studies, up to a 2-year follow-up. An extended 5-year follow-up is planned to discard the occurrence of late events

Referencias bibliográficas

  • 1. Neumann F-J, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. European Heart Journal. 2018;40:87-165.
  • 2. Lüscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, et al. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007;115:1051-8.
  • 3. Gori T, Polimeni A, Indolfi C, Räber L, Adriaenssens T, Münzel T. Predictors of stent thrombosis and their implications for clinical practice. Nature Reviews Cardiology. 2019;16:243-256.
  • 4. Estevez-Loureiro R, Perez de Prado A, Perez-Martinez C, Cuellas-Ramon C, Regueiro-Purrinos M, Gonzalo-Orden JM, et al. Safety and Efficacy of New Sirolimus-eluting stent Models in a Preclinical Study. Rev Esp Cardiol (Engl Ed). 2015;68:1118-24.
  • 5. Puri R, Otaegui I, Sabate M, Serra-Penaranda A, Puigfel M, Perez de Prado A, et al. Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite(R) drug-eluting stent : The ANCHOR study. Catheter Cardiovasc Interv. 2018;91:435-443.
  • 6. Moreu J, Moreno-Gomez R, Perez de Prado A, Garcia Del Blanco B, Trillo R, Pinar E, et al. First-in-man randomised comparison of the Angiolite durable fluoroacrylate polymer-based sirolimus-eluting stent versus a durable fluoropolymer-based everolimus-eluting stent in patients with coronary artery disease: the ANGIOLITE trial. EuroIntervention. 2019;15:e1081-e1089.
  • 7. Valgimigli M, Bueno H, Byrne RA, Collet J-P, Costa F, Jeppsson A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2017;39:213-260.
  • 8. Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, et al. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018;137:2635-2650.
  • 9. Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, et al. Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronarystent System) IV trial. J Am Coll Cardiol. 2011;58:19-25.
  • 10. Waltenberger J, Hoffmann S, Brachmann J, Van Der Heijden J, Richardt G, Froebert O, et al. Bioflow-III: one year target lesion failure data of an all-comers registry with a drug eluting stent. European Heart Journal. 2013;34:P3036-P3036.
  • 11. Pilgrim T, Heg D, Roffi M, Tüller D, Muller O, Vuilliomenet A, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet. 2014;384:2111-22.
  • 12. Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, et al. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent : the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015;8.
  • 13. Kereiakes DJ, Meredith IT, Masotti M, Carrie D, Moreno R, Erglis A, et al. Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy. EuroIntervention. 2017;12:1987-1994.
  • 14. Kim CH, Lee E, Kang J, Han J-K, Yang H-M, Park KW, et al. TCT-754 One-year clinical outcome of patients treated with Resolute Onyx versus Resolute Integrity: A Comparison of the HOST-ONYX and HOST-RESOLINTE Registries. Journal of the American College of Cardiology. 2017;70:B319-B319.
  • 15. Tam CC, Chan K, Lam S, Yung A, Lam YM, Chan C, et al. One-year clinical outcomes of patients implanted with a Resolute Onyx zotarolimus-eluting stent. J Int Med Res. 2018;46:457-463.
  • 16. von Birgelen C, Zocca P, Buiten RA, Jessurun GAJ, Schotborgh CE, Roguin A, et al. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt–chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. The Lancet. 2018;392:1235-1245.
  • 17. Wijns W, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez-Romo A, Barbato E, et al. Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation: final five-year results of the CENTURY II randomised clinical trial. EuroIntervention. 2018;14:e343-e351.
  • 18. Jeger RV, Farah A, Ohlow M-A, Mangner N, Möbius-Winkler S, Leibundgut G, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. The Lancet. 2018;392:849-856.
Fonte de datos: Dialnet