Philip Urban1, Mariano Valdés2, Ian Menown3, Franz Eberli4, Imad Alhaddad5, David Hildick-Smith6, David Iosseliani7, Marco Roffi8, Keith Oldroyd9, Erifyli Kalloudi10, Pedro Eerdmans10, Jacques Berland11, Franz Xaver Kleber12. 1. Department of Cardiovascular, Hôpital De La Tour, Geneva, Switzerland. 2. Hospital Universitario Virgen De La Arrixaca, Murcia, Spain. 3. Department of Cardiology, Craigavon Cardiovascular Centre, Craigavon, United Kingdom. 4. Stadtspital Triemli, Zurich, Switzerland. 5. The Cardiovascular Center, Jordan Hospital, Amman, Jordan. 6. Brighton and Sussex Hospital, Brighton, United Kingdom. 7. Moscow City Center of Interventional Cardioangiology, Moscow, Russian Federation. 8. Hôpitaux Universitaires De Genève, Geneva, Switzerland. 9. Golden Jubilee National Hospital, Glasgow, United Kingdom. 10. Biosensors Europe, Morges, Switzerland. 11. Department of Cardiology, Clinique Saint-Hilaire, Rouen, France. 12. Cardio Centrum Berlin, Academic Teaching Institution, Charité University Medicine, Berlin, Germany.
Abstract
OBJECTIVES: To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice. BACKGROUND: The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent. METHODS: 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years. RESULTS: Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST. CONCLUSIONS: This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.
OBJECTIVES: To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice. BACKGROUND: The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent. METHODS: 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years. RESULTS: Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST. CONCLUSIONS: This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.
Authors: Eric Maupas; Janusz Lipiecki; Raphy Levy; Benjamin Faurie; Bernard Karsenty; Marc Eric Moulichon; François Brunelle; Luc Maillard; Fabien de Poli; Thierry Lefèvre Journal: Catheter Cardiovasc Interv Date: 2017-05-22 Impact factor: 2.692
Authors: Abhilash Akinapelli; Jack P Chen; Kristine Roy; Joseph Donnelly; Keith Dawkins; Barbara Huibregtse; Dongming Hou Journal: Curr Cardiol Rev Date: 2017
Authors: Ian B A Menown; Mamas A Mamas; James M Cotton; David Hildick-Smith; Franz R Eberli; Gregor Leibundgut; Damras Tresukosol; Carlos Macaya; Samuel Copt; Sara Sadozai Slama; Hans-Peter Stoll Journal: Int J Cardiol Heart Vasc Date: 2020-01-27