Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.


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Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.
Catheterization and cardiovascular interventions
Urban P., Valdés M., Menown I., Eberli F., Alhaddad I., Hildick-Smith D., Iosseliani D., Roffi M., Oldroyd K., Kalloudi E., Eerdmans P., Berland J., Kleber F.X.
Working group(s)
e-Biomatrix investigators
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.
1522-726X (Electronic)
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Publication types: Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
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.
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
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22/08/2017 15:26
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15/09/2022 5:38
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