MATRIX Supports The Medicines Company's Bivalirudin in High-Risk PCI Patients

September 1, 2015—The Medicines Company announced that results from the antithrombin program of the MATRIX trial were presented during a Hot Line session of the European Society of Cardiology’s ESC Congress 2015 and published by Marco Valgimigli, MD, et al online ahead of print in The New England Journal of Medicine (NEJM). The ESC Congress 2015 is being held August 29 to September 2 in London, United Kingdom.

MATRIX is a large international, open-label, multicenter clinical trial comparing the company’s antithrombotic agent, bivalirudin (marketed as Angiox in Europe and Angiomax in the United States), against heparin in 7,213 acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) via transradial access. The MATRIX trial was sponsored by the Societa Italiana di Cardiologia Invasiva with funding from The Medicines Company and Terumo. 

According to The Medicines Company, MATRIX showed that Angiomax/Angiox was associated with similar rates of the primary outcome of composite major ischemic and net adverse events compared with heparin, but with significantly lower rates of the secondary outcomes of death and major bleeding. 

In the data presented at ESC, MATRIX did not show a statistical difference between Angiomax/Angiox and heparin on the primary outcome measures of major adverse cardiovascular events and net adverse clinical events caused by high rates of myocardial infarction, which were not different between the two treatment groups. However, the trial demonstrated a 29% reduction in the secondary endpoints of all-cause mortality and a 45% to 50% reduction in major bleeding according to the established BARC (Bleeding Academic Research Consortium) and TIMI (Thrombolysis in Myocardial Infarction) bleeding scales, respectively. There were no differences noted on stroke rates between the two study treatments.

MATRIX reported that prolonged infusions at the full PCI dose may mitigate the risk for acute stent thrombosis without any excess in bleeding, while low-dose prolonged infusions were not protective against stent thrombosis; this was consistent with the observations from previous multicenter trials (EUROMAX, BRIGHT).

In March 2015, the results of the MATRIX access site program comparing femoral to radial access in 8,404 ACS patients were presented at the American College of Cardiology’s 64th annual scientific session in San Diego, California, and published by Dr. Valgimigli, et al in The Lancet (2015;385:2465–2476).

Dr. Marco Valgimigli, the MATRIX trial’s Principal Investigator, commented in the company’s press release, “The MATRIX program demonstrated that radial access outperformed femoral access and that bivalirudin, even in patients undergoing transradial intervention, lowers bleeding and has potential to decrease mortality over heparin.” Dr. Valgimigle is from the Inselspital, Bern University Hospital in Bern, Switzerland.

Dr. Valfimigli added, “Our continued analysis of the MATRIX data is providing further clarity on how to best maximize the advantages of both radial access and bivalirudin in these high risk patients. The postprocedural infusion data presented for the first time today suggest that a prolonged full dose bivalirudin infusion has an acceptable safety profile. While no significant difference in overall outcome was noted in patients receiving the post-PCI bivalirudin infusion as compared to those who did not, subsequent analysis based on the post-PCI bivalirudin regimen suggested that the full PCI dose regimen has potential to mitigate any excess risk for early stent thrombosis without increasing bleeding.”

In Europe, Angiox is indicated as an anticoagulant for adult patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-STEMI planned for urgent or early intervention.

In the United States, Angiomax is indicated in patients undergoing PCI with provisional use of a glycoprotein IIb/IIIa inhibitor and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with ACS not undergoing PCI or PTCA, advised The Medicines Company.