Jens Wiebe1, Moritz Baquet2, Oliver Dörr3, Petra Hoppmann4, David Jochheim2, Tobias Rheude5, Niklas Boeder3, David Grundmann2, Florian Blachutzik3, Hans Theiss2, Salvatore Cassese5, Felix J Hofmann3, Sarah Gschwendtner2, Albrecht Elsässer6, Steffen Massberg7, Christian Hamm3, Karl-Ludwig Laugwitz8, Robert A Byrne9, Julinda Mehilli7, Adnan Kastrati9, Holger Nef3. 1. Deutsches Herzzentrum München, Technische Universität München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany. Electronic address: wiebe@dhm.mhn.de. 2. Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany. 3. University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany. 4. 1. med. Klinik, Klinikum rechts der Isar, Technische Universität München, Germany. 5. Deutsches Herzzentrum München, Technische Universität München, Germany. 6. Klinikum Oldenburg, Department of Cardiology, Germany. 7. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany; Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany. 8. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany; 1. med. Klinik, Klinikum rechts der Isar, Technische Universität München, Germany. 9. Deutsches Herzzentrum München, Technische Universität München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany.
Abstract
BACKGROUND: Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. METHODS: Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. RESULTS: A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. CONCLUSIONS: In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS.
BACKGROUND: Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. METHODS: Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. RESULTS: A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. CONCLUSIONS: In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS.
Authors: Maciej T Wybraniec; Paweł Bańka; Tomasz Bochenek; Tomasz Roleder; Katarzyna Mizia-Stec Journal: Cardiol J Date: 2020-09-28 Impact factor: 2.737