Titre
Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.
Type
recension de livre
Institution
Externe
Auteur(s)
Urban, P.
Auteure/Auteur
Valdés, M.
Auteure/Auteur
Menown, I.
Auteure/Auteur
Eberli, F.
Auteure/Auteur
Alhaddad, I.
Auteure/Auteur
Hildick-Smith, D.
Auteure/Auteur
Iosseliani, D.
Auteure/Auteur
Roffi, M.
Auteure/Auteur
Oldroyd, K.
Auteure/Auteur
Kalloudi, E.
Auteure/Auteur
Eerdmans, P.
Auteure/Auteur
Berland, J.
Auteure/Auteur
Kleber, F.X.
Auteure/Auteur
Contributrices/contributeurs
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.
Groupes de travail
e-Biomatrix investigators
Liens vers les personnes
ISSN
1522-726X
Statut éditorial
Publié
Date de publication
2015-12-01
Volume
86
Numéro
7
Première page
1151
Dernière page/numéro d’article
1160
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
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.
Sujets
PID Serval
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PMID
Open Access
Oui
Date de création
2017-08-22T14:26:34.282Z
Date de création dans IRIS
2025-05-21T02:32:33Z
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