MATRIX Studies Explore New Treatments for ACS Patients
Journal Wrap | Two separate trials—both part of the MATRIX study and presented as part of the Late-Breaking Clinical Trials at ACC.15—looked at strategies to reduce major bleeding and mortality in patients with acute coronary syndrome (ACS).
The first trial, also simultaneously published in the Lancet, found greater reductions in risk of major bleeding and mortality in ACS patients who underwent coronary angiography and percutaneous coronary intervention (PCI) using transradial instead of transfemoral access. Author Marco Valgimigli, MD, PhD, and colleagues, conducted a 1:1 randomized superiority trial to compare transradial access against transfemoral access in ACS patients who were undergoing coronary angiography and PCI.
The study looked at 8,404 patients from 78 health centers in Italy, the Netherlands, Spain and Sweden. Results demonstrated that the patient population in the transradial access group had slightly better clinical outcomes (8.8%) than those in the transfemoral access (10.3%). Investigators noted that while transradial versus transfemoral access was shown to reduce major bleeds and all-cause mortality, it was not found to reduce heat attack or stroke.
“Differences did not reach statistical significance for major adverse cardiovascular events as one of the two co-primary outcomes, and one can argue that the results for secondary outcomes, including all-cause mortality, are not definite since their α levels were not adjusted for multiple comparisons,” said Valgimigli. “However, our results need to be interpreted in the context of the updated meta-analysis (panel), which suggests highly significant benefits of radial access in acute coronary syndrome patients for major adverse cardiovascular events (p = 0.0051) and all-cause mortality (p = 0.0011) with no evidence of statistical heterogeneity between trials.”
In the second study, Valgimigli and team found that ACS patients undergoing angioplasty did not see significant improvement in risk of cardiac events or cardiac events plus major bleeding after taking bivalirudin as compared with standard care. However, bivalirudin was shown to significantly lower the risk of complications and mortality related to bleeding.
The randomized trial included 7,200 ACS patients who were about to undergo angioplasty, from 78 hospitals in four European countries. Patients were given either bivalirudin or standard coagulation therapy (unfractionated heparin). Results of the study found bivalirudin did not improve outcomes of cardiac events and cardiac events plus major bleeding. However, the bivalirudin group had a significantly lower rate of death, most likely due to the reduction of bleed complications especially near the catheter insertion site, which occurred in 1.7% of patients versus 2.3% of patients in the standard care group.
“We saw an impressive reduction in bleeding with bivalirudin compared to the control, which likely contributed to the reduced mortality in this group,” said Valgimigli. “I believe the study shows bivalirudin can provide additional benefits to patients as compared to unfractionated heparin in current medical practice.”
Valgimigli noted that this study comes at a good time to re-evaluate the role of bivaluridin. A series of other recent studies have had inconsistent and hotly debated outcomes. Unlike the other studies, clinicians in the MATRIX study were able to decide whether or not glycoprotein IIb/IIIa inhibitors would complement standard protocol. “Glycoprotein IIb/IIIa inhibitors were used in about one-quarter of the control patients in our study, at the operator’s discretion, which is a better reflection of current practice than the control protocol used in previous studies,” Valgimigli said.
Valgimigli M, Gangor A, Calabro P, et al. Lancet. 2015;doi:10.1016/S0140-6736(15)60292-6.
Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Anticoagulation Management and ACS, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: CardioSource WorldNews Interventions, ACC Publications, Acute Coronary Syndrome, Angioplasty, Complement System Proteins, Coronary Angiography, Heparin, Hirudins, Peptide Fragments, Percutaneous Coronary Intervention, Recombinant Proteins, Platelet Glycoprotein GPIIb-IIIa Complex
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