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

ICDs, non-ischemic cardiomyopathy, University of Alabama at Birmingham study, Circulation
News | Implantable Cardioverter Defibrillators (ICD)| January 18, 2017
A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-...
stress, brain activity, cardiovascular risk, PET-CT, MGH, ISSMS, The Lancet study
News | Cardiac Diagnostics| January 18, 2017
A study led by Massachusetts General Hospital (MGH) and Icahn School of Medicine at Mount Sinai (ISSMS) investigators...
electronic health records, EHR, warfarin therapy management, University of Missouri Health Care, blood thinner
News | Antiplatelet and Anticoagulation Therapies| January 17, 2017
Warfarin is a commonly prescribed blood thinner used to prevent harmful blood clots. However, the drug requires...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD)| January 17, 2017
Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac...
University of Utah, Frank Sachse, heart failure, LVAD implantation, left ventricular assist device, biomarker, t-system

Two patients may seem equally sick based upon clinical measures, but differences in their heart physiology could predict who has the potential to recover from heart failure. A study carried out by scientists at the University of Utah finds that patients whose hearts have flattened t-tubules have a decreased chance of showing signs of recovery after implanting a mechanical heart pump. Ordinarily, t-tubules in the heart are long, thin, and rounded. Image courtesy of Frank Sachse.

News | Cardiac Diagnostics| January 17, 2017
Investigators at the University of Utah have identified distinct differences in the hearts of advanced heart failure...
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
St. Jude Medical, Amplatzer Amulet LAA Occluder, observational study, TCT 2016
News | Left Atrial Appendage (LAA) Occluders| November 03, 2016
St. Jude Medical Inc. presented favorable results from the largest observational study to date of the company’s...
Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
congenital heart patients, cardiac cath lab, anesthesia sedation practices, joint document, SCAI, SPA, CCAS
News | Congenital Heart| November 03, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the...
open-heart surgery, PCI, percutaneous coronary intervention, NOBLE trial, left main coronary artery disease, LMCAD, TCT 2016
News | Cardiovascular Surgery| November 03, 2016
Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main...
Overlay Init