Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX: Bivalirudin vs. Heparin - MATRIX: Bivalirudin vs. Heparin

Description:

The goal of the trial was to evaluate bivalirudin compared with unfractionated heparin among subjects undergoing cardiac catheterization for acute coronary syndromes.

Contribution to the Literature: The MATRIX trial showed that bivalirudin did not reduce major or net adverse events vs. heparin; however, bleeding/death was reduced and stent thrombosis increased.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with acute coronary syndromes (ST-segment elevation myocardial infarction [STEMI] and non-STEMI [NSTEMI]) were randomized to bivalirudin (n = 3,610) versus unfractionated heparin with planned or bailout glycoprotein IIb/IIIa inhibitor (n = 3,603). Patients randomized to bivalirudin were subsequently randomized to a post-PCI bivalirudin infusion versus no post-PCI bivalirudin infusion. The infusion could be administered at full dose for 4 hours or reduced dose for 6 hours according to operator discretion. By factorial design, patients were also randomized to radial access versus femoral access (reported separately).

Patient population:

  • Total number of enrollees: 7,213
  • Duration of follow-up: 30 days
  • Mean patient age: 65 years
  • Percentage female: 24%

Other salient features/characteristics:

  • Presentation: STEMI 56%, NSTEMI 40%
  • Pre-lab ADP antagonist: clopidogrel 47%, ticagrelor or prasugrel 36%
  • Glycoprotein IIb/IIIa inhibitor: 4.6% with bivalirudin, 26% with heparin
  • Unfractionated heparin before study drug administration: 32% in the bivalirudin group, 33% in the heparin group

Inclusion criteria:

  • Patients with acute coronary syndromes undergoing cardiac catheterization

Principal Findings:

The first co-primary outcome of death, MI, or stroke occurred in 10.3% of the bivalirudin group versus 10.9% of the heparin group (p = 0.44). The second co-primary outcome of death, MI, stroke, or major bleeding (BARC 3 or 5) occurred in 11.2% of the bivalirudin group versus 12.4% of the heparin group (p = 0.12).

Post-percutaneous coronary intervention (PCI) infusion of bivalirudin did not reduce the occurrence of urgent target vessel revascularization, stent thrombosis, or net adverse clinical events: 11.0% vs. 11.9% for no post-PCI infusion (p = 0.34).  

Secondary outcomes:

  • All-cause death: 1.7% vs. 2.3% (p = 0.042), respectively, for bivalirudin vs. heparin
  • MI: 8.6% vs. 8.5% (p = 0.92), respectively, for bivalirudin vs. heparin (most of these were periprocedural events)
  • Stroke: 0.4% vs. 0.5% (p = 0.57), respectively, for bivalirudin vs. heparin
  • Stent thrombosis (definite): 1.0% vs. 0.6% (p = 0.048), respectively, for bivalirudin vs. heparin
  • Major bleeding (BARC 3 or 5): 1.4% vs. 2.5% (p = 0.001), respectively, for bivalirudin vs. heparin

Interpretation:

Among patients with acute coronary syndromes undergoing PCI, bivalirudin failed to reduce major adverse cardiovascular events or net adverse events compared with unfractionated heparin with planned or bailout glycoprotein IIb/IIIa inhibitor. While bivalirudin was not associated with a reduction in the co-primary endpoints, this medicine was associated with a reduction in all-cause mortality and major bleeding (BARC 3 or 5); however, there was an increase in stent thrombosis. Several lines of evidence now suggest an increased risk of stent thrombosis with bivalirudin.

References:

Valgimigli M, Frigoli E, Leonardi S, et al., on behalf of the MATRIX Investigators. Bivalirudin or unfractionated heparin in acute coronary syndromes. N Engl J Med 2015;Sep 1:[Epub ahead of print].

Editorial: Berger PB. Finding the proper context for the MATRIX trial. N Engl J Med 2015;Sep 1:[Epub ahead of print].

Presented by Dr. Marco Valgimigli at the European Society of Cardiology Congress, London, September 1, 2015.

Presented by Dr. Marco Valgimigli at ACC.15, San Diego, CA, March 16, 2015.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Clinical Topic Collection: Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and ACS, Lipid Metabolism, Novel Agents, Interventions and ACS

Keywords: ACC Annual Scientific Session, Acute Coronary Syndrome, Antithrombins, Heparin, Hirudins, Myocardial Infarction, Percutaneous Coronary Intervention, Stents, Stroke, Thrombin, Thrombosis, ESC Congress


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