Skip to main content
Erschienen in: The International Journal of Cardiovascular Imaging 7/2019

04.05.2019 | Original Paper

Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions

Erschienen in: The International Journal of Cardiovascular Imaging | Ausgabe 7/2019

Einloggen, um Zugang zu erhalten

Abstract

We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
3.
Zurück zum Zitat Gomez-Lara J, Radu M, Brugaletta S, Farooq V, Diletti R, Onuma Y, Windecker S, Thuesen L, McClean D, Koolen J, Whitbourn R, Dudek D, Smits PC, Regar E, Veldhof S, Rapoza R, Ormiston JA, Garcia-Garcia HM, Serruys PW (2011) Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. JACC Cardiovasc Interv 4(9):992–1001. https://doi.org/10.1016/j.jcin.2011.03.020 CrossRefPubMed Gomez-Lara J, Radu M, Brugaletta S, Farooq V, Diletti R, Onuma Y, Windecker S, Thuesen L, McClean D, Koolen J, Whitbourn R, Dudek D, Smits PC, Regar E, Veldhof S, Rapoza R, Ormiston JA, Garcia-Garcia HM, Serruys PW (2011) Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. JACC Cardiovasc Interv 4(9):992–1001. https://​doi.​org/​10.​1016/​j.​jcin.​2011.​03.​020 CrossRefPubMed
8.
Zurück zum Zitat Verheye S, Ormiston JA, Stewart J, Webster M, Sanidas E, Costa R, Costa JR Jr, Chamie D, Abizaid AS, Pinto I, Morrison L, Toyloy S, Bhat V, Yan J, Abizaid A (2014) A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. JACC Cardiovasc Interv 7(1):89–99. https://doi.org/10.1016/j.jcin.2013.07.007 CrossRefPubMed Verheye S, Ormiston JA, Stewart J, Webster M, Sanidas E, Costa R, Costa JR Jr, Chamie D, Abizaid AS, Pinto I, Morrison L, Toyloy S, Bhat V, Yan J, Abizaid A (2014) A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. JACC Cardiovasc Interv 7(1):89–99. https://​doi.​org/​10.​1016/​j.​jcin.​2013.​07.​007 CrossRefPubMed
9.
Zurück zum Zitat Burzotta F, Talarico GP, Trani C, De Maria GL, Pirozzolo G, Niccoli G, Leone AM, Saffioti S, Porto I, Crea F (2014) Frequency-domain optical coherence tomography findings in patients with bifurcated lesions undergoing provisional stenting. Eur Heart J Cardiovasc Imaging 15(5):547–555. https://doi.org/10.1093/ehjci/jet231 CrossRefPubMed Burzotta F, Talarico GP, Trani C, De Maria GL, Pirozzolo G, Niccoli G, Leone AM, Saffioti S, Porto I, Crea F (2014) Frequency-domain optical coherence tomography findings in patients with bifurcated lesions undergoing provisional stenting. Eur Heart J Cardiovasc Imaging 15(5):547–555. https://​doi.​org/​10.​1093/​ehjci/​jet231 CrossRefPubMed
11.
Zurück zum Zitat Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y (2014) Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention 10(5):545–560. https://doi.org/10.4244/EIJV10I5A97 CrossRefPubMed Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y (2014) Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention 10(5):545–560. https://​doi.​org/​10.​4244/​EIJV10I5A97 CrossRefPubMed
12.
Zurück zum Zitat Karanasos A, Tu S, van Ditzhuijzen NS, Ligthart JM, Witberg K, Van Mieghem N, van Geuns RJ, de Jaegere P, Zijlstra F, Reiber JH, Regar E (2015) A novel method to assess coronary artery bifurcations by OCT: cut-plane analysis for side-branch ostial assessment from a main-vessel pullback. Eur Heart J Cardiovasc Imaging 16(2):177–189. https://doi.org/10.1093/ehjci/jeu176 CrossRefPubMed Karanasos A, Tu S, van Ditzhuijzen NS, Ligthart JM, Witberg K, Van Mieghem N, van Geuns RJ, de Jaegere P, Zijlstra F, Reiber JH, Regar E (2015) A novel method to assess coronary artery bifurcations by OCT: cut-plane analysis for side-branch ostial assessment from a main-vessel pullback. Eur Heart J Cardiovasc Imaging 16(2):177–189. https://​doi.​org/​10.​1093/​ehjci/​jeu176 CrossRefPubMed
13.
Zurück zum Zitat Ali ZA, Serruys PW, Kimura T, Gao R, Ellis SG, Kereiakes DJ, Onuma Y, Simonton C, Zhang Z, Stone GW (2017) 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet 390(10096):760–772. https://doi.org/10.1016/S0140-6736(17)31470-8 CrossRefPubMed Ali ZA, Serruys PW, Kimura T, Gao R, Ellis SG, Kereiakes DJ, Onuma Y, Simonton C, Zhang Z, Stone GW (2017) 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet 390(10096):760–772. https://​doi.​org/​10.​1016/​S0140-6736(17)31470-8 CrossRefPubMed
14.
Zurück zum Zitat Kawamoto H, Latib A, Ruparelia N, Miyazaki T, Sticchi A, Naganuma T, Sato K, Figini F, Chieffo A, Carlino M, Montorfano M, Colombo A (2015) Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: overall outcomes and comparison between provisional and planned double stenting strategy. Catheter Cardiovasc Interv 86(4):644–652. https://doi.org/10.1002/ccd.26045 CrossRefPubMed Kawamoto H, Latib A, Ruparelia N, Miyazaki T, Sticchi A, Naganuma T, Sato K, Figini F, Chieffo A, Carlino M, Montorfano M, Colombo A (2015) Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: overall outcomes and comparison between provisional and planned double stenting strategy. Catheter Cardiovasc Interv 86(4):644–652. https://​doi.​org/​10.​1002/​ccd.​26045 CrossRefPubMed
15.
Zurück zum Zitat Mattesini A, Secco GG, Dall’Ara G, Ghione M, Rama-Merchan JC, Lupi A, Viceconte N, Lindsay AC, De Silva R, Foin N, Naganuma T, Valente S, Colombo A, Di Mario C (2014) ABSORB biodegradable stents versus second-generation metal stents: a comparison study of 100 complex lesions treated under OCT guidance. JACC Cardiovasc Interv 7(7):741–750. https://doi.org/10.1016/j.jcin.2014.01.165 CrossRefPubMed Mattesini A, Secco GG, Dall’Ara G, Ghione M, Rama-Merchan JC, Lupi A, Viceconte N, Lindsay AC, De Silva R, Foin N, Naganuma T, Valente S, Colombo A, Di Mario C (2014) ABSORB biodegradable stents versus second-generation metal stents: a comparison study of 100 complex lesions treated under OCT guidance. JACC Cardiovasc Interv 7(7):741–750. https://​doi.​org/​10.​1016/​j.​jcin.​2014.​01.​165 CrossRefPubMed
16.
Zurück zum Zitat Finet G, Derimay F, Motreff P, Guerin P, Pilet P, Ohayon J, Darremont O, Rioufol G (2015) Comparative analysis of sequential proximal optimizing technique versus kissing balloon inflation technique in provisional bifurcation stenting: fractal coronary bifurcation bench test. JACC Cardiovasc Interv 8(10):1308–1317. https://doi.org/10.1016/j.jcin.2015.05.016 CrossRefPubMed Finet G, Derimay F, Motreff P, Guerin P, Pilet P, Ohayon J, Darremont O, Rioufol G (2015) Comparative analysis of sequential proximal optimizing technique versus kissing balloon inflation technique in provisional bifurcation stenting: fractal coronary bifurcation bench test. JACC Cardiovasc Interv 8(10):1308–1317. https://​doi.​org/​10.​1016/​j.​jcin.​2015.​05.​016 CrossRefPubMed
17.
Zurück zum Zitat Abizaid A, Costa RA, Schofer J, Ormiston J, Maeng M, Witzenbichler B, Botelho RV, Costa JR Jr, Chamie D, Abizaid AS, Castro JP, Morrison L, Toyloy S, Bhat V, Yan J, Verheye S (2016) Serial multimodality imaging and 2-year clinical outcomes of the novel desolve novolimus-eluting bioresorbable coronary scaffold system for the treatment of single de novo coronary lesions. JACC Cardiovasc Interv 9(6):565–574. https://doi.org/10.1016/j.jcin.2015.12.004 CrossRefPubMed Abizaid A, Costa RA, Schofer J, Ormiston J, Maeng M, Witzenbichler B, Botelho RV, Costa JR Jr, Chamie D, Abizaid AS, Castro JP, Morrison L, Toyloy S, Bhat V, Yan J, Verheye S (2016) Serial multimodality imaging and 2-year clinical outcomes of the novel desolve novolimus-eluting bioresorbable coronary scaffold system for the treatment of single de novo coronary lesions. JACC Cardiovasc Interv 9(6):565–574. https://​doi.​org/​10.​1016/​j.​jcin.​2015.​12.​004 CrossRefPubMed
20.
Zurück zum Zitat Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S (2008) A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 371(9616):899–907. https://doi.org/10.1016/S0140-6736(08)60415-8 CrossRefPubMed Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S (2008) A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 371(9616):899–907. https://​doi.​org/​10.​1016/​S0140-6736(08)60415-8 CrossRefPubMed
21.
Zurück zum Zitat Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA (2011) Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol 58(15):1578–1588. https://doi.org/10.1016/j.jacc.2011.05.050 CrossRefPubMed Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA (2011) Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol 58(15):1578–1588. https://​doi.​org/​10.​1016/​j.​jacc.​2011.​05.​050 CrossRefPubMed
Metadaten
Titel
Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions
Publikationsdatum
04.05.2019
Erschienen in
The International Journal of Cardiovascular Imaging / Ausgabe 7/2019
Print ISSN: 1569-5794
Elektronische ISSN: 1875-8312
DOI
https://doi.org/10.1007/s10554-019-01537-5

Weitere Artikel der Ausgabe 7/2019

The International Journal of Cardiovascular Imaging 7/2019 Zur Ausgabe

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.