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Outcomes following implantation of the biolimus A9‐eluting Bio M atrix coronary stent: Primary analysis of the e‐ B io M atrix registry
Author(s) -
Urban Philip,
Valdés Mariano,
Menown Ian,
Eberli Franz,
Alhaddad Imad,
HildickSmith David,
Iosseliani David,
Roffi Marco,
Oldroyd Keith,
Kalloudi Erifyli,
Eerdmans Pedro,
Berland Jacques,
Kleber Franz Xaver
Publication year - 2015
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25892
Subject(s) - medicine , stent , cardiology , surgery
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. © 2015 Wiley Periodicals, Inc.