Estudio observacional prospectivo EPIC03-BIOSS. Análisis del stent dedicado BIOSS LIM C en angioplastias en bifurcación

  1. Bruno García del Blanco 1
  2. Josep Gómez Lara 2
  3. Juan Carlos Rama Merchán 3
  4. Luis R. Goncalves Ramírez 4
  5. Imanol Otaegui 1
  6. Eduard Bosch Peligero 5
  7. Julio Carballo 6
  8. Jorge Palazuelos Molinero 7
  9. Juan A. Bullones Ramírez 8
  10. Juan Manuel Casanova Sandoval 9
  11. José R. Rumoroso Cuevas 10
  12. Germán Calle Pérez 11
  13. Eduard Fernández-Nofrerías 12
  14. María Ángeles Carmona Ramírez 1
  15. Armando Pérez de Prado 4
  1. 1 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitari Vall d’Hebrón, Barcelona, España
  2. 2 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, España
  3. 3 Unidad de Hemodinámica, Servicio de Cardiología, Hospital de Mérida, Mérida, Badajoz, España
  4. 4 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitario de León, León, España
  5. 5 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Parc Taulí, Sabadell, Barcelona, España
  6. 6 Unidad de Hemodinámica, Servicio de Cardiología, Centro Médico Teknon, Barcelona, España
  7. 7 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Central de la Defensa Gómez-Ulla, Madrid, España
  8. 8 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitario Regional de Málaga, Málaga, España
  9. 9 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitari Arnau de Vilanova, Lleida, España
  10. 10 Unidad de Hemodinámica, Servicio de Cardiología, Hospital de Galdakao-Usansolo, Galdakao, Bizkaia, España
  11. 11 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitario Puerta del Mar, Cádiz, España
  12. 12 Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España
Journal:
REC: Interventional Cardiology

ISSN: 2604-7276 2604-7306

Year of publication: 2022

Volume: 4

Issue: 4

Pages: 294-303

Type: Article

DOI: 10.24875/RECIC.M22000310 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: REC: Interventional Cardiology

Abstract

Introduction and objectives: To describe the efficacy of the BIOSS LIM C dedicated sirolimus-eluting stent to treat coronary bifurcation lesions, and impact on the bifurcation angle and carina through quantitative coronary angiography. Methods: Observational prospective study including 124 patients with bifurcation lesions treated with a BIOSS LIM C dedicated sirolimus-eluting stent excluding restenotic lesions and those without main vessel involvement. Results: The stent was successfully deployed in 121 patients (97.6%) while in 18 (14.5%) double stenting was used. The quantitative coronary analysis has shown proper stent expansion with a mean residual stenosis of 18% in the proximal segment, nearly 0% in the distal segment, and 21% in the side branch. The angiographic results of double stenting showed higher mean diameters (2.12 ± 0.30 vs 1.60 ± 0 .42; P < .001), and lower residual stenosis (18.36 ± 9.94 vs 28.49 ± 14.19%, P < .01). Distortion imposed on the bifurcation angulation was minimal with an absolute reduction of 5 degrees (52.8 ± 18.4 vs 47.5 ± 17.2; P = .001). Conclusions: The dedicated BIOSS LIM C stent has had a very high success rate to treat coronary bifurcation lesions. Angiographic results are good with a remarkably low impact on the native bifurcation angulation, and excellent results from double stenting. We think this can be a very useful device to treat coronary bifurcation lesions with the advantage of easing out the bailout deployment of a second stent into the side branch.

Bibliographic References

  • 1. Ojeda S, Romaguera R, Cruz-González I, Moreno R. Spanish Cardiac Catheterization and Coronary Intervention Registry. 29th Official Report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2019). Rev Esp Cardiol. 2020;73:927-936.
  • 2. Burzotta F, Lassen JF, Lefèbre T, et al. Percutaneous coronary intervention for bifurcation coronary lesions: the 15th consensus document from the European Bifurcation Club. EuroIntervention. 2021;16:1307-1317.
  • 3. Huo Y, Kassab GS. Scaling laws of coronary circulation in health and disease. J Biomech. 2016;49:2531-2539.
  • 4. Foin N, Sen S, Allegria E, et al. Maximal expansion capacity with current DES platforms: a critical factor for stent selection in the treatment of left main bifurcations? EuroIntervention. 2013;8:1315-1325.
  • 5. Finet G, Derimay F, Motreff P, et al. Comparative Analysis of Sequential Proximal Optimizing Technique Versus Kissing Balloon Inflation Technique in Provisional Bifurcation Stenting: Fractal Coronary Bifurcation Bench Test. JACC Cardiovasc Interv. 2015;8:1308-1317.
  • 6. Maeng M, Hom NR, Erglis A, et al. Long-term results after simple versus complex stenting of coronary artery bifurcation lesions: Nordic Bifurcation Study 5-year follow-up results. J Am Coll Cardiol. 2013;62:30-34.
  • 7. Hildick-Smith D, Behan MW, Lassen JF, et al. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations. Circ Cardiovasc Interv. 2016;9:e003643.
  • 8. Ferenc M, Gick M, Kienzle R-P, et al. Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J. 2008;29:2859.
  • 9. Ferenc M, Ayoub M, Büttner HJ, et al. Long-term outcomes of routine versus provisional T-stenting for de novo coronary bifurcation lesions: five-year results of the Bifurcations Bad Krozingen I study. EuroIntervention. 2015;11:856-859.
  • 10. Erglis A, Kumsars I, Niemelä M, et al. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study. Circ Cardiovasc Interv. 2009;2:27-34.
  • 11. Gil RJ, Bil J, Kern A, Pawłowski T. First-in-man study of dedicated bifurcation cobalt-chromium sirolimus-eluting stent BIOSS LIM C® - Three-month results. Kardiol Pol. 2018;76:464-470.
  • 12. Gil RJ, Bil J, Grundeken MJ, et al. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. EuroIntervention. 2016;12:1246-1254.
  • 13. Gil RJ, Bil J, Vassiliev D, Garcia LAI. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry. J Interv Cardiol. 2015;28:51-60.
  • 14. Gil RJ, Bil J, Grundeken MJ, et al. Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial. EuroIntervention. 2016;12:e1404-e1412.
  • 15. Lefèvre T, Ormiston J, Guagliumi G, et al. The Frontier stent registry: safety and feasibility of a novel dedicated stent for the treatment of bifurcation coronary artery lesions. J Am Coll Cardiol. 2005;46:592-598.
  • 16. Costa RA, Abizaid A, Abizaid AS, et al. Procedural and early clinical outcomes of patients with de novo coronary bifurcation lesions treated with the novel Nile PAX dedicated bifurcation polymer-free paclitaxel coated stents: results from the prospective, multicentre, non-randomised BIPAX clinical trial. EuroIntervention. 2012;7:1301-1309.
  • 17. TCT-50: Complex Coronary Bifurcation Lesions Treated with the Novel Polymer-Free Dedicated Bifurcation Paclitaxel-Eluting Stent (Nile Pax): 9-Month Clinical and Angiographic Results of the Prospective, Multicenter BIPAX Clinical Trial. J Am Coll Cardiol. 2011;58:B15.
  • 18. Verheye S, Agostoni P, Dubois CL, et al. 9-Month clinical, angiographic, and intravascular ultrasound results of a prospective evaluation of the Axxess self-expanding biolimus A9-eluting stent in coronary bifurcation lesions: the DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) study. J Am Coll Cardiol. 2009;53:1031-1039.
  • 19. Gil RJ, Bil J, Džavík V, et al. Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial. Can J Cardiol. 2015;31:671-678.
  • 20. Godino C, Al-Lamee R, C La Rosa C, et al. Coronary left main and non-left main bifurcation angles: how are the angles modified by different bifurcation stenting techniques? J Interv Cardiol. 2010;23:382-393.