Sergio Leonardi, clinician investigator1, Enrico Frigoli, study physician leader2, Martina Rothenbühler, statistician34, Eliano Navarese, consultant interventional cardiologist5, Paolo Calabró, associate professor6, Paolo Bellotti, interventional cardiologist7, Carlo Briguori, interventional cardiologist8, Marco Ferlini, interventional cardiologist1, Bernardo Cortese, interventional cardiologist9, Alessandro Lupi, interventional cardiologist10, Salvatore Lerna, interventional cardiologist11, Dennis Zavallonito-Parenti, interventional cardiologist12, Giovanni Esposito, associate professor13, Simone Tresoldi, interventional cardiologist14, Antonio Zingarelli, interventional cardiologist15, Stefano Rigattieri, interventional cardiologist16, Cataldo Palmieri, interventional cardiologist17, Armando Liso, interventional cardiologist18, Fabio Abate, interventional cardiologist19, Marco Zimarino, interventional cardiologist20, Marco Comeglio, interventional cardiologist21, Gabriele Gabrielli, interventional cardiologist22, Alaide Chieffo, interventional cardiologist23, Salvatore Brugaletta, interventional cardiologist24, Ciro Mauro, interventional cardiologist25, Nicolas M Van Mieghem, interventional cardiologist26, Dik Heg, statistician34, Peter Jüni, professor27, Stephan Windecker, professor28, Marco Valgimigli, professor of clinical research in interventional cardiology28 for the MATRIX Investigators

Abstract

Objective To test the optimal antithrombotic regimen in patients with acute coronary syndrome.

Design Randomised controlled trial.

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

Participants 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.

Interventions 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.

Main outcome measures 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.

BMJ