Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.
Details
State: Public
Version: author
License: All rights reserved
Serval ID
serval:BIB_CCB0CC3653EC
Type
Article: article from journal or magazin.
Publication sub-type
Minutes: analyse of a published work.
Collection
Publications
Institution
Title
Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.
Journal
Catheterization and cardiovascular interventions
Working group(s)
e-Biomatrix investigators
Contributor(s)
Metzler B., Weidinger F., Christ G., Kala P., Cervinka P., Carstensen S., Kische S., Mulvihill N., Mahon N., Alhaddad I.A., Erglis A., Unikas R., Chaara A., Boukili A., Lesiak M., Kalawski B., Fernandes R., Kozlov K.L., Iosseliani D.G., Picó-Aracil F., García B., Ramón Rumoroso J., Lopez Palop R., Berenguer A., Trillo R., Valdés Chavarri M., Rodriguez Collado J., Urban P., Eberli F., Templin C., Weilenmann D., Cook S., Goy J.J., Roffi M., Pedrazzini G., Windecker S., Hill J., Menown I., Oldroyd K., Uren N., Cotton J., Aziz S., Blackman D., O'Rourke B., Lowe R., Talwar S., Sarkar D., Grech E., Hildick Smith D., El-Omar M., Clarke S., Spence M., Walsh S., Goode G., Kukreja N., Witherow F., Bagnall A., Signy M., Chieffo A., Kastrati A., Peruga J.Z., Poerner T.C., Wöhrle J., Radke P., Mauri F., Albarran A., Moreno R., Roguelov C., Girod G., Birkemeyer R., Rosenberg M., Lyon X., Jensen L., Urban P., Roffi M., Hildick-Smith D., Oldroyd K., Kleber F.X., Valdés M., Berland J., Iosseliani D., Alhaddad I., Eberli F., Menown I., Piault R., Eerdmans P., Meis S.
ISSN
1522-726X (Electronic)
ISSN-L
1522-1946
Publication state
Published
Issued date
01/12/2015
Peer-reviewed
Oui
Volume
86
Number
7
Pages
1151-1160
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice.
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.
5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years.
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.
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.
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.
5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years.
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.
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.
Keywords
Aged, Cardiovascular Agents/administration & dosage, Comorbidity, Coronary Artery Disease/diagnosis, Coronary Artery Disease/mortality, Coronary Artery Disease/therapy, Coronary Thrombosis/etiology, Coronary Thrombosis/mortality, Drug Therapy, Combination, Drug-Eluting Stents, Female, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/etiology, Myocardial Infarction/mortality, Percutaneous Coronary Intervention/adverse effects, Percutaneous Coronary Intervention/instrumentation, Percutaneous Coronary Intervention/mortality, Platelet Aggregation Inhibitors/therapeutic use, Proportional Hazards Models, Registries, Risk Factors, Sirolimus/administration & dosage, Sirolimus/analogs & derivatives, Time Factors, Treatment Outcome, bleeding, drug eluting stent, dual antiplatelet therapy, stent thrombosis
Pubmed
Web of science
Open Access
Yes
Create date
22/08/2017 16:26
Last modification date
15/09/2022 6:38
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