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Bivalirudin linked to reduced bleeding in patients with STEMI undergoing PCI
Compared with heparin or heparin combined with glycoprotein IIb/IIIa inhibitors, bivalirudin treatment was associated with reduced adverse clinical events in patients with STEMI undergoing PCI after thrombolytic therapy treatment, according to findings published in Catheterization and Cardiovascular Interventions.
“Only 36% of the acute care hospitals in the United States have the capability of performing primary PCI, and approximately 42 million Americans live outside a 60-[minute] pre-hospital time window to a PCI-capable hospital,” Jaya R. Mallidi, MD, MHS, from the division of cardiology and department of internal medicine at Baystate Medical Center at Tufts University, Springfield, Massachusetts, and colleagues wrote in the study background. “Hence, thrombolytic therapy is still a widely used initial reperfusion strategy, especially if the transfer time to a PCI-capable facility is more than 120 [minutes].”
To assess the safety and efficacy of bivalirudin vs. heparin alone or heparin plus glycoprotein IIb/IIIa inhibitors, researchers performed a retrospective analysis of 695 patients who underwent urgent PCI within 24 hours of thrombolytic therapy.
Primary endpoints for MACE were a composite of inpatient death, MI and stroke.
Net adverse clinical events (NACE) were MACE plus major bleeding complications.
To compare MACE and NACE between the three treatment groups, researchers used univariable, multivariable and propensity-weighted modeling.
Of the 695 patients included in the study, 260 patients (38.7%) were given unfractionated heparin as the antithrombotic agent during PCI, 343 received bivalirudin (48.5%) and 92 (12.8%) were given glycoprotein IIb/IIIa inhibitors with heparin.
The univariable analysis showed no significant difference in MACE among the three groups (bivalirudin, 1.2%; heparin plus glycoprotein IIb/IIIa inhibitors, 4.4%; heparin alone, 2.7%; P = .11).
A reduced logistic regression model showed that odds of NACE were higher with heparin alone (OR = 3.58, 95% CI, 1.21-10.54) and with heparin plus glycoprotein IIb/IIIa inhibitors (OR = 9; 95% CI, 2.83-28.64) compared with bivalirudin.
Although the results were positive, Mallidi and colleagues wrote that there are several limitations to the study, including unmeasured confounders; possible bias in the allocation of anticoagulation, which was left up to the discretion of the interventional cardiologist; the lack of long-term results; and other factors that call for further study.
“Further large-scale prospective, randomized trials are warranted to evaluate long-term clinical outcomes with use of bivalirudin anticoagulation during PCI after thrombolytic therapy,” Mallidi and colleagues wrote. – by Dave Quaile
Disclosure: The researchers report no relevant financial disclosures.