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

• Published in: Catheterization and cardiovascular interventions Vol. 86; no. 7; pp. 1151 - 1160
• Main Authors: Urban, Philip, Valdés, Mariano, Menown, Ian, Eberli, Franz, Alhaddad, Imad, Hildick-Smith, David, Iosseliani, David, Roffi, Marco, Oldroyd, Keith, Kalloudi, Erifyli, Eerdmans, Pedro, Berland, Jacques, Kleber, Franz Xaver
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.12.2015; Wiley Subscription Services, Inc
• Subjects: Aged; bleeding; Cardiovascular Agents - administration & dosage; Comorbidity; Coronary Artery Disease - diagnosis; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary Thrombosis - etiology; Coronary Thrombosis - mortality; drug eluting stent; Drug Therapy, Combination; Drug-Eluting Stents; dual antiplatelet therapy; 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; stent thrombosis; Time Factors; Treatment Outcome; dual antiplatelet therapy; drug eluting stent; bleeding; stent thrombosis
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.25892

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 CypherTM 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. © 2015 Wiley Periodicals, Inc.