Holger Nef1, Jens Wiebe2, Niklas Boeder1, Oliver Dörr1, Timm Bauer1, Karl-Eugen Hauptmann3, Azeem Latib4, Antonio Colombo4, Dieter Fischer5, Tanja Rudolph6, Nicolas Foin7, Gert Richardt8, Christian Hamm1. 1. Department of Cardiology and Angiology, University of Giessen, Medizinische Klinik I, Giessen, Germany. 2. Department of Cardiology, Deutsches Herzzentrum Muenchen, Munich, Germany. 3. Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany. 4. Ospedale San Raffaele, Milan, Italy. 5. Department of Cardiology and Angiology, University of Münster, Münster, Germany. 6. Department of Cardiology, University of Cologne, Cologne, Germany. 7. National Heart Centre Singapore, Duke-NUS Medical School, Singapore, Singapore. 8. Department of Cardiology, Segeberger Kliniken, Bad Segeberg, Germany.
Abstract
OBJECTIVES: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. BACKGROUND: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. METHODS: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. RESULTS: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. CONCLUSIONS: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.
OBJECTIVES: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. BACKGROUND: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactonemTOR inhibitor. METHODS: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. RESULTS: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. CONCLUSIONS: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.
Authors: Mateusz P Jeżewski; Michał J Kubisa; Ceren Eyileten; Salvatore De Rosa; Günter Christ; Maciej Lesiak; Ciro Indolfi; Aurel Toma; Jolanta M Siller-Matula; Marek Postuła Journal: J Clin Med Date: 2019-12-07 Impact factor: 4.241
Authors: Niklas F Boeder; Oliver Dörr; Rosalina Gaderer; Florian Blachutzik; Stephan Achenbach; Albrecht Elsässer; Christian Hamm; Holger M Nef Journal: Postepy Kardiol Interwencyjnej Date: 2021-09-20 Impact factor: 1.426
Authors: Stefan Verheye; Adrian Wlodarczak; Piero Montorsi; Jan Torzewski; Johan Bennett; Michael Haude; Gregory Starmer; Thomas Buck; Marcus Wiemer; Amin A B Nuruddin; Bryan P-Y Yan; Michael K-Y Lee Journal: Catheter Cardiovasc Interv Date: 2020-09-03 Impact factor: 2.692