Author + information
- Christian T. Ruff,
- Angele Moryusef,
- Amarachi Umez-Eronini,
- Elaine Hoffman,
- Christophe Gaudin,
- Elliott Antman,
- Marc Sabatine,
- TIMI Study Group
The benefits and risks of an anticoagulant in ACS may depend on whether it is supporting PCI.
In a post-hoc analysis, we compared the novel, intravenous factor Xa inhibitor otamixaban (OTAM) vs. unfractionated heparin (UFH) + eptifibatide (EPT) on efficacy (death/MI) and safety (TIMI non-CABG major/minor bleeding) through 7 d in NSTE-ACS patients in SEPIA-ACS1 TIMI 42, focusing on the pooled OTAM doses (0.105 & 0.140 mg/kg/h) similar to those being carried forward in phase 3 and stratifying patients by PCI (n=1101) or not (n=668).
98% of patients underwent angiography, 63% PCI, 4% CABG, and 33% medical therapy alone. Regardless of PCI, the pooled doses of OTAM significantly reduced death/MI (RR 0.54, P=0.02) w/o increasing bleeding (RR 1.20, P=0.56) compared to UFH+EPT. The benefit of OTAM in reducing death/MI was consistent regardless of PCI (PCI: RR 0.65; No PCI: RR 0.36; P-interaction=0.32). Bleeding rates tended to be higher with OTAM vs UFH+EPT in patients undergoing PCI (RR 1.56, 95% 0.69–3.50) whereas they tended to be lower in those not undergoing PCI (RR 0.73, 95% CI 0.26–2.07), with no significant heterogeneity (P-interaction=0.26). Among all patients, use of radial access (21%) was associated with lower bleeding rates (1.3 % vs. 3.6%, P=0.03).
The doses of OTAM being carried forward in the ongoing phase 3 TAO trial may offer an attractive alternative to UFH+EPT in patients with NSTEACS regardless of whether they undergo PCI; radial access may mitigate bleeding.
Oral Contributions West, Room 3001
Sunday, March 10, 2013, 8:30 a.m.-8:45 a.m.
Session Title: ACS: Therapies on the Horizon
Abstract Category: 3. Acute Coronary Syndromes: Therapy
Presentation Number: 912-5
- 2013 American College of Cardiology Foundation