Comparison of intra-procedural vs. post-stenting prolonged bivalirudin infusion for residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing: the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study.


Journal

European heart journal. Cardiovascular Imaging
ISSN: 2047-2412
Titre abrégé: Eur Heart J Cardiovasc Imaging
Pays: England
ID NLM: 101573788

Informations de publication

Date de publication:
01 Dec 2019
Historique:
received: 09 01 2019
accepted: 25 02 2019
pubmed: 29 3 2019
medline: 29 6 2021
entrez: 29 3 2019
Statut: ppublish

Résumé

To compare prolonged bivalirudin infusion vs. an intra-procedural only bivalirudin infusion administration in subjects with ST-segment elevation myocardial infarction (STEMI) regarding residual stent strut thrombosis. Multivessel STEMI patients undergoing primary percutaneous coronary intervention (PPCI) and scheduled for a staged percutaneous coronary intervention (PCI) before hospital discharge were selected among those allocated to either prolonged bivalirudin or intra-procedural only bivalirudin infusion in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of PPCI and 4-5 days thereafter during staged intervention. The predefined endpoint was the percentage difference in the number of stent cross-sections with a thrombotic area >5% at the end of PPCI and at the time of staged PCI (ΔThCS). Between September 2013 and November 2015, 137 were randomized to either intra-procedural only bivalirudin infusion (N = 64) or prolonged bivalirudin (N = 73) at 16 European sites. Mean stent area, minimum lumen area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The difference in the proportion of frames with percent thrombotic area >5% (ΔTh > 5%) were -7.7 (-22.1 to 5.1) in the intra-procedural bivalirudin infusion group and -8.8 (-23.1 to 2.6) in the prolonged infusion group (P = 0.994). Time from index to follow-up OCT imaging and the infarct vessel artery did not affect this OCT-based endpoint. A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).

Identifiants

pubmed: 30920584
pii: 5421472
doi: 10.1093/ehjci/jez040
doi:

Substances chimiques

Hirudins 0
Peptide Fragments 0
Recombinant Proteins 0
bivalirudin TN9BEX005G

Banques de données

ClinicalTrials.gov
['NCT01433627']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1418-1428

Informations de copyright

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.

Auteurs

Hector M Garcia-Garcia (HM)

MedStar Washington Hospital Center, Washington, DC, USA.

Andrea Picchi (A)

Misericordia Hospital, Grosseto, Italy.

Gennaro Sardella (G)

Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.

Marianna Adamo (M)

Azienda Ospedaliera Spedali Civili, Brescia, Italy.

Enrico Frigoli (E)

Clinical Trials Unit, University of Bern, Bern, Switzerland.

Ugo Limbruno (U)

Misericordia Hospital, Grosseto, Italy.

Stefano Rigattieri (S)

Sandro Pertini Hospital, Rome, Italy.

Roberto Diletti (R)

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Giacomo Boccuzzi (G)

San Giovanni Bosco Hospital, Turin, Italy.

Marco Zimarino (M)

Università degli Studi "G. d'Annunzio" Chieti e Pescara, Chieti, Italy.

Marco Contarini (M)

Ospedale Umberto I, Siracusa, Italy.

Filippo Russo (F)

Azienda Ospedaliera Sant'Anna, Como, Italy.

Paolo Calabro' (P)

Division of Cardiology, Department of Cardiothoracic and Respiratory Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

Giuseppe Andò (G)

Azienda Ospedaliera Universitaria G. Martino, Messina, Italy.

Ferdinando Varbella (F)

Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy.

Stefano Garducci (S)

Unita' Operativa Complessa di Cardiologia ASST di Vimercate (MB), Vimercate, Italy.

Cataldo Palmieri (C)

Institute of Clinical Physiology, C.N.R./G. Monasterio Foundation, Massa, Italy.

Carlo Briguori (C)

Clinica Mediterranea, Napoli, Italy.

Kayode O Kuku (KO)

Misericordia Hospital, Grosseto, Italy.

Martina Rothenbühler (M)

Clinical Trials Unit, University of Bern, Bern, Switzerland.

Alexios Karagiannis (A)

Clinical Trials Unit, University of Bern, Bern, Switzerland.

Marco Valgimigli (M)

Swiss Cardiovascular Center Bern, Bern University Hospital, Freiburgstrasse 8, Bern, Switzerland.

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Classifications MeSH