Hector M Garcia-Garcia1, Michael Haude2, Kayode Kuku3, Alexandre Hideo-Kajita3, Hüseyin Ince4, Alexandre Abizaid5, Ralph Tölg6, Pedro Alves Lemos7, Clemens von Birgelen8, Evald Høj Christiansen9, William Wijns10, Javier Escaned11, Jouke Dijkstra12, Ron Waksman3. 1. Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: hector.m.garciagarcia@medstar.net. 2. Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. 3. Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. 4. Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. 5. Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. 6. Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. 7. Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. 8. Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. 9. Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. 10. Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. 11. Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. 12. LKEB, Leiden University, Leiden, The Netherlands.
Abstract
RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.
RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.
Authors: Yuxin Zeng; Zeyi Guan; Chase S Linsley; Shuaihang Pan; Jingke Liu; Benjamin M Wu; Xiaochun Li Journal: J Biomed Mater Res B Appl Biomater Date: 2022-05-06 Impact factor: 3.405
Authors: Maria Natalia Tovar Forero; Laurens van Zandvoort; Kaneshka Masdjedi; Roberto Diletti; Jeroen Wilschut; Peter P de Jaegere; Felix Zijlstra; Nicolas M Van Mieghem; Joost Daemen Journal: Catheter Cardiovasc Interv Date: 2019-04-29 Impact factor: 2.692
Authors: Sergio Loffredo; Sofia Gambaro; Francesco Copes; Carlo Paternoster; Nicolas Giguère; Maurizio Vedani; Diego Mantovani Journal: Bioact Mater Date: 2021-10-21
Authors: Michael Haude; Hüseyin Ince; Stephan Kische; Alexandre Abizaid; Ralph Tölg; Pedro Alves Lemos; Nicolas M Van Mieghem; Stefan Verheye; Clemens von Birgelen; Evald Høj Christiansen; Emanuele Barbato; Hector M Garcia-Garcia; Ron Waksman Journal: Catheter Cardiovasc Interv Date: 2018-08-05 Impact factor: 2.692