Why the study?
Does bivalirudin alone reduce major bleeding and improve net clinical outcomes compared to heparin or GPI-based regimens in patients with NSTE-ACS undergoing an early invasive strategy?
RCT (n=13,819)
randomized
Does bivalirudin alone reduce major bleeding and improve net clinical outcomes compared to heparin or GPI-based regimens in patients with NSTE-ACS undergoing an early invasive strategy?
In patients with NSTE-ACS undergoing an early invasive strategy, upstream medical management with bivalirudin alone significantly reduces major bleeding and improves net clinical outcomes compared to heparin or GPI-based regimens.
Answers are grounded in this paper and cite their sources.
Supports bivalirudin monotherapy to reduce bleeding in early invasive NSTE-ACS; extends prior RCTs by confirming net clinical benefit with comparable MACE.
AIM: To evaluate the impact of antithrombotic regimens during the medical phase of treatment among 13,819 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) treated with an early invasive strategy in the acute catheterization and urgent intervention triage strategy (ACUITY) trial. METHODS AND RESULTS: Endpoints included composite major adverse cardiac events (MACE), major bleeding, and net adverse clinical events (NACE; MACE or major bleeding). The median (interquartile range) duration of antithrombin use in the medical only treatment phase was 6.5 (1.8-22.5) hours. MACE, major bleeding, and NACE during the medical only phase occurred in 63 (0.5%), 117 (0.9%), and 178 (1.3%) patients, respectively. MACE rates in the medical-treatment-only phase were not significantly different between the four randomized medical regimens used (heparin alone, bivalirudin alone, heparin plus a glycoprotein IIb/IIIa inhibitor [GPI], and bivalirudin plus GPI) (Ptrend = 0.65). The lowest rates of major bleeding and NACE during the medical treatment phase occurred in patients treated with bivalirudin alone (Ptrend = 0.0006 and Ptrend = 0.0004, respectively). CONCLUSIONS: In patients with NSTE-ACS undergoing an early invasive strategy, treatment with bivalirudin alone significantly reduced major bleeding and improved net clinical outcomes during the upstream medical management phase with comparable rates of MACE.
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Geisler et al. (2015) conducted an RCT in non-ST-segment elevation acute coronary syndromes (NSTE-ACS) (n=13,819). bivalirudin alone vs. heparin alone, heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), and bivalirudin plus GPI was evaluated on composite major adverse cardiac events (MACE), major bleeding, and net adverse clinical events (NACE) (p=Ptrend = 0.0004).
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