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.


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