Feature | September 05, 2013

Anticoagulant Does Not Reduce Rate of Ischemic Events Among Certain Patients Undergoing PCI

September 5, 2013 — Use of the novel anticoagulant otamixaban did not reduce ischemic events compared with unfractionated heparin plus eptifibatide but increased bleeding among patients with non–ST-segment elevation acute coronary syndromes undergoing a percutaneous coronary intervention (PCI), according to a clinical study published by JAMA. The study was released early online to coincide with its presentation at the European Society of Cardiology Congress 2013.

“Major progress has been made in the management of non–ST-segment elevation acute coronary syndromes (NSTE-ACS) because of the availability of potent combinations of oral antiplatelet agents, injectable anticoagulants and increasing use of an invasive strategy. Nevertheless, the risk of adverse outcomes remains substantial, and there is no consensus on a single optimal injectable anticoagulant that can be used across the continuum of care from the emergency setting through revascularization (when applicable),” according to background information in the article. The synthetic intravenous drug otamixaban inhibits thrombin [an enzyme that acts on fibrinogen in blood causing it to clot] generation in a dose-dependent manner. A Phase 2 trial showed a reduction in the combined outcome of death or myocardial infarction (heart attack) in patients treated with otamixaban compared with unfractionated heparin (UFH) plus eptifibatide (an antiplatelet drug) and showed similar bleeding rates with otamixaban at midrange doses.

Philippe Gabriel Steg, M.D., of the Université Paris-Diderot, Sorbonne-Paris Cité, Paris, and investigators with the TAO trial compared the clinical efficacy and safety of otamixaban with that of unfractionated heparin plus eptifibatide in 13,229 patients with NSTE-ACS and a planned early invasive strategy. The trial was conducted at 568 active sites in 55 countries between April 2010 and February 2013. Eligible participants were randomized to otamixaban or unfractionated heparin plus, at the time of PCI, eptifibatide.

The primary outcome of death or new myocardial infarction through day seven occurred in 5.5 percent of the patients treated with otamixaban vs. 5.7 percent of the patients treated with UFH plus eptifibatide. Otamixaban did not significantly reduce the risk of any of the components of the primary outcomes, either death or heart attack, or of any of the secondary efficacy outcomes, including procedural thrombotic complications. Analysis of the primary outcome by 30 days confirmed the absence of a reduction with otamixaban.

In the lower-dose otamixaban group, discontinued by the data monitoring committee for futility based on the interim analysis, the rate of the primary outcome at day seven was 6.3 percent.

Patients in the otamixaban group had about double the rate of the primary safety outcome of thrombosis in myocardial infarction major or minor bleeding at day seven compared with patients in the combination of UFH-plus-eptifibatide group (3.1 vs. 1.5 percent). Otamixaban consistently increased all types of bleeding events, regardless of the severity or bleeding classification scheme used. Study anticoagulant was discontinued because of bleeding in 242 patients (4.7 percent) in the otamixaban group and in 95 patients (1.7 percent) in the UFH-plus-eptifibatide group.

“Otamixaban did not reduce ischemic events compared with UFH plus eptifibatide but increased bleeding among patients with NSTE-ACS and a planned invasive strategy. These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention,” the authors conclude.

Related Content

Sci-image, Scimage, CVIS, CIIMS, Cpacs c-pacs, cardiovascular information system

Today's cardiovascular information systems need to incorporate all facets of the cardiology department, including subspecialties, to allow a complete picture of a patient's record. These data also need to be able to be shared with enterprise data systems, such as the electronic medical record (EMR). This image is from ScImage, illustrating the various aspects that integrate to make up a complete CVIS. 

 

Feature | September 29, 2016 | Val Kapitula, RT(R), PMP, CIIP
Cardiovascular Information and Imaging Systems (CVIS) have existed for many years in the dedicated sub-specialty area
Keystone Heart, TriGuard Embolic Protection Device, real-world results, PCR London Valves Conference 2016
News | Embolic Protection Devices| September 29, 2016
Keystone Heart Ltd. recently announced the safety and efficacy of the TriGuard Cerebral Embolic Protection device...
Neuravi, EmboTrap II stent retriever, thrombectomy device, acute stroke, European launch, CE Mark
News | Thrombectomy Devices| September 28, 2016
Neuravi recently announced Conformité Européenne (CE) Mark approval and launch of the company’s newly available...
Infinix 4D CT

Toshiba's Infinix 4D CT, which combines CT with angiography in the interventional lab.

Feature | Angiography| September 28, 2016 | Tom Watson BS, RCVT, Clinical Analyst, MD Buyline
One of the more significant advancements for interventional X-ray (IXR) in the past few years has been a significantl
TCT 2016, TCT.16, main arena, late breaking trials
Feature | Cath Lab| September 28, 2016
September 28, 2016 — The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 fi
Avinger, U.S. Department of Veterans Affairs, VA, Lumivascular technology, FSS Contract Award
News | Optical Coherence Tomography (OCT)| September 27, 2016
Avinger Inc. recently announced the company has received an FSS Contract Award from the U.S. Department of Veterans...
News | Pharmaceuticals| September 26, 2016
Nearly 2 out of 5 people with diabetes who could benefit from statin therapy to lower their risk of future heart attack...
Bard, Lutonix 014 DCB, drug-coated balloon, six-month endpoint, FDA IDE trial
Technology | Drug-Eluting Balloons| September 26, 2016
C. R. Bard Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE...
smartphones, hospital tranfers, heart attack patients, JACC study, South Korea
News | Mobile Devices| September 23, 2016
Smartphone communication among medical teams at different hospitals can significantly reduce the time it takes for...
Robert M. Califf, FDA commissioner, future of cardiovascular medicine, JACC column
News | Business| September 23, 2016
Technology advances coupled with increased use of social media and personal devices could offer new possibilities for...
Overlay Init