Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial.
OBJECTIVE
To test the optimal antithrombotic regimen in patients with acute coronary syndrome.


METHODS
Randomised controlled trial.


METHODS
Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden.


METHODS
7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously.


METHODS
Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors.


METHODS
Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat.


RESULTS
Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43).


CONCLUSIONS
A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation.Trial Registration ClinicalTrials.gov NCT01433627.
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Sergio
S
Leonardi
EUSTRATEGY Association, Forli', Italy.
Enrico
E
Frigoli
CTU Bern, University of Bern, Switzerland Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland.
Martina
M
Rothenbühler
Policlinico Multimedica IRCSS, University of Milan, Milan, Italy.
Eliano
E
Navarese
Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
Paolo
P
Calabró
Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy.
Paolo
P
Bellotti
Clinica Mediterranea, Napoli, Italy.
Carlo
C
Briguori
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Marco
M
Ferlini
Ospedale Fatebene Fratelli, Milano, Italy.
Bernardo
B
Cortese
University Hospital Maggiore della Carità, Novara, Italy.
Alessandro
A
Lupi
Ospedale Sirai-Carbonia, Carbonia, Italy.
Salvatore
S
Lerna
Humanitas Research Hospital, IRCCS, Rozzano, Italy.
Dennis
D
Zavallonito-Parenti
Division of Cardiology-Department of Advanced Biomedical Sciences, Federico II University of Naples.
Giovanni
G
Esposito
A O Ospedale di Desio, Lombardia, Italy.
Simone
S
Tresoldi
IRCCS San Martino-IST, Genoa, Italy.
Antonio
A
Zingarelli
Interventional Cardiology Sandro Pertini Hospital Rome, Italy.
Stefano
S
Rigattieri
Ospedale Pasquinucci, Massa, Italy.
Cataldo
C
Palmieri
Citta' di Lecce Hospital, Lecce, Italy.
Armando
A
Liso
Ospedale Giovanni Paolo II, Sciacca, Italy.
Fabio
F
Abate
Università degli Studi G d'Annunzio Chieti e Pescara, Chieti, Italy.
Marco
M
Zimarino
Ospedale San Jacopo, Pistoia, Italy.
Marco
M
Comeglio
Azienda Ospedali Riuniti-Presidio GM Lancisi, Ancona, Italy.
Gabriele
G
Gabrielli
Ospedale San Raffaele IRCCS, Milano, Italy.
Alaide
A
Chieffo
Hospital Clinic, Cardiovascular Institute, IDIBAPS, Barcelona, Spain.
Salvatore
S
Brugaletta
AORN Cardarelli, Napoli, Italy.
Ciro
C
Mauro
Erasmus MC, Rotterdam, Netherlands.
Nicolas M
NM
Van Mieghem
CTU Bern, University of Bern, Switzerland Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland.
Dik
D
Heg
Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, and Department of Medicine, University of Toronto, Canada.
Peter
P
Jüni
Swiss Cardiovascular Centre Bern, Bern University Hospital, CH-3010 Bern, Switzerland.
Stephan
S
Windecker
Swiss Cardiovascular Centre Bern, Bern University Hospital, CH-3010 Bern, Switzerland marco.valgimigli@insel.ch.
Marco
M
Valgimigli