Bivalirudin or Heparin in Patients Undergoing Invasive Management of AcuteCoronarySyndromes
Randomized controlled trial published in J Am Coll Cardiol (2018)
Abstract
BACKGROUND: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs). OBJECTIVES: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding). RESULTS: Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site. CONCLUSIONS: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Резюме
Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs).
Почему это важно для гирудотерапии
This randomized controlled trial (the MATRIX program; 7,213 patients with acute coronary syndrome) compared bivalirudin to unfractionated heparin with or without glycoprotein IIb/IIIa inhibitors during invasive management. Bivalirudin did not significantly reduce major adverse cardiovascular events or net adverse clinical events compared to heparin, but significantly reduced bleeding complications—particularly severe non-access-site bleeds—irrespective of planned GPI use. The abstract makes no reference to leeches, hirudin, or leech-derived molecules, and provides no basis for any connection to hirudotherapy or the leech secretome. This is a clinical cardiology trial with no demonstrable relevance to ASH's domain.
Цитирование
Bivalirudin or Heparin in Patients Undergoing Invasive Management of AcuteCoronarySyndromes.
Gargiulo G et al. · J Am Coll Cardiol, 2018
Связанный клинический контекст
Узнайте, как это исследование связано с клинической практикой
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