Key result
Post-PCI bivalirudin is linked to similar periprocedural MI but less minor bleeding versus UFH plus GPI.
Why the study?
Does a prolonged bivalirudin infusion for 4 hours post-PCI improve safety and efficacy compared to UFH plus GPI in patients with acute coronary syndrome undergoing complex PCI?
Cohort (n=109)
Does a prolonged bivalirudin infusion for 4 hours post-PCI improve safety and efficacy compared to UFH plus GPI in patients with acute coronary syndrome undergoing complex PCI?
Absolute Event Rate: 8% vs 11.9%
p-value: p=NS
A prolonged 4-hour bivalirudin infusion after complex PCI in ACS patients appears to reduce minor bleeding without increasing ischemic events compared to UFH plus GPI.
Prolonged post-PCI bivalirudin may lower periprocedural MI without excess bleeding versus UFH+GPI or shorter infusion; leaves open confirmation in randomized trials.
OBJECTIVE: Bivalirudin, a direct thrombin inhibitor, provides similar ischemic outcomes with significantly less major bleeding compared with unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary interventions (PCI). Although the approved labeling for bivalirudin allows for low-dose prolonged postprocedure administration, this practice is not routine. Therefore, we sought to evaluate the safety and efficacy of longer post-PCI infusion. METHODS: From our database, we retrospectively compared two groups of patients with acute coronary syndrome undergoing complex PCI, one group treated with UFH+GPI (n = 59) and another with a periprocedural and post-PCI bivalirudin infusion for 4 h (n = 50). Endpoints included periprocedural myocardial infarction (MI), 30-day major adverse cardiac events, and in-hospital major and minor bleeding. RESULTS: There were no significant differences in the baseline and procedural characteristics of the two groups; most patients (approximately 90%) had complex coronary lesions (the American College of Cardiology/American Heart Association type B2/C). There was no significant difference in the rates of periprocedural MI (11.9 vs. 8.0%, P = NS) or 30-day major adverse cardiac events (8.5 vs. 6.0%, P = NS) among patients treated with UFH+GPI or bivalirudin. However, patients who received bivalirudin had significantly lower rates of minor bleeding (20.3 vs. 4.0%, P<0.05), and a trend toward significantly less major bleeding (8.5 vs. 4.0%, P = 0.07). When we compared the group treated with a prolonged bivalirudin infusion with a historical group treated with peri-PCI-only bivalirudin infusion, we observed in the latter an increased incidence of periprocedural MI and a comparable incidence of bleeding. CONCLUSION: A prolonged bivalirudin infusion after urgent PCI seems effective in protecting myocardium without increasing bleeding rates, and represents an attractive alternative to the standard pharmacological treatment of UFH+GPI in the catheterization laboratory.
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Cortese et al. (2009) conducted a cohort in Acute coronary syndrome undergoing complex PCI (n=109). Prolonged bivalirudin infusion vs. Unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) was evaluated on Periprocedural myocardial infarction (MI) (p=NS). A prolonged 4-hour bivalirudin infusion after complex PCI resulted in similar rates of periprocedural MI (8.0% vs 11.9%, P=NS) and significantly less minor bleeding compared to UFH plus a GPI.
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