Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III

EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Michael HaudeRon Waksman

Abstract

We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant. The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis. The present analysis provides additional evidence on the safety of a drug-eluting absorbable...Continue Reading

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Citations

Jan 5, 2018·European Heart Journal·Steen Dalby KristensenWilliam Wijns
Jul 19, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Thomas MarynissenJohan Bennett
Aug 7, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Michael HaudeUNKNOWN BIOSOLVE-II and III investigators
Sep 24, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Marcos García-GuimaraesFernando Alfonso
Aug 13, 2017·Circulation. Cardiovascular Interventions·Yoshinobu Onuma, Patrick W Serruys
Nov 13, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Giorgio QuadriFerdinando Varbella
Jan 25, 2019·Expert Review of Medical Devices·Ply ChichareonYoshinobu Onuma
Apr 20, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Sunny GoelUmesh Gidwani
Mar 22, 2019·Minerva cardioangiologica·Dhruv Mahtta, Islam Y Elgendy
Nov 12, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Trine Ø BarkholtJohn A Ormiston
Nov 26, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Jeremías BayónCarlos González-Juanatey
Feb 6, 2020·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Yoshinobu Onuma, Patrick W Serruys
Feb 26, 2019·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Michael HaudeRon Waksman
Mar 1, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Johan Bennett, Keir McCutcheon
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May 6, 2020·European Heart Journal Supplements : Journal of the European Society of Cardiology·Tobias LenzMichael Joner
Dec 11, 2019·Journal of Clinical Medicine·Mateusz P JeżewskiMarek Postuła
Feb 29, 2020·World Journal of Clinical Cases·Hizuru AmanoHiroo Uchida
Sep 4, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Stefan VerheyeMichael K-Y Lee
Dec 12, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Adrian WlodarczakMaciej Lesiak
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Mar 2, 2021·Materials Science & Engineering. C, Materials for Biological Applications·Sachiko HiromotoKotaro Doi
Mar 7, 2021·Cardiovascular Revascularization Medicine : Including Molecular Interventions·Stefano GalliGiuseppe Tarantini
Mar 20, 2021·Expert Review of Medical Devices·Xinlei WuYoshinobu Onuma
Apr 2, 2021·Journal of Biomaterials Science. Polymer Edition·Jean FajadetAntoine Lafont
May 30, 2021·Cardiovascular Revascularization Medicine : Including Molecular Interventions·Yuichi OzakiMichael Haude
Jun 27, 2021·Cardiovascular Revascularization Medicine : Including Molecular Interventions·Jacques J Koolen
Dec 31, 2021·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Trine Ø BarkholtNiels R Holm

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