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Bivalirudin substantially reduces bleeding risk compared with heparin and glycoprotein IIb/IIIa inhibitors (GPIs) in patients undergoing percutaneous coronary intervention (PCI) who have renal dysfunction, according to a study published online November 26, 2013, ahead of print in Circulation: Cardiovascular Interventions. The effect was seen across the full range of renal dysfunction categories.

Researchers led by Hitinder S. Gurm, MD, of the University of Michigan Cardiovascular Center (Ann Arbor, MI), evaluated outcomes of 64,052 patients who underwent PCI between 2007 and 2009 at 33 Michigan hospitals. Patients were treated with bivalirudin (n = 28,378), or heparin and GPIs (n = 35,674; 95% received eptifibatide, others received abciximab) and were included as part of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

Bivalirudin was associated with a lower incidence of transfusion, gastrointestinal bleeding, vascular complications, CABG, and death (table 1).

Table 1. Unadjusted Outcomes: Heparin + GPI vs. Bivalirudin

Propensity-matched analysis maintained these results with the exception of death. There were no differences in major adverse cardiac outcomes other than CABG (table 2).

Table 2. Propensity-matched Analysis: Heparin + GPIs vs. Bivalirudin

Additionally, bivalirudin was associated with reduced risk of hematoma (P < 0.0001), but there were no differences based on treatment for acute thrombosis or loss of limb.

Not surprisingly, the risk of bleeding complications increased with worsening CKD. The effect of bivalirudin was preserved across all categories of renal dysfunction, with fewer transfusions and GI bleeds associated with the drug compared with heparin and GPIs in all categories.

Optimal Antithrombotic Option?

Dr. Gurm told TCTMD in an e-mail communication that the findings were not surprising. “I have been quite happy with the lower bleeding [rates] with bivalirudin in my patients with renal dysfunction, and the results of the analysis confirmed my personal experience,” he said.

The study does carry certain limitations given its observational design, but the researchers concluded that the sensitivity analysis suggests the robust efficacy of bivalirudin. Data on drug dosing also was not collected, meaning that medications may not have been adjusted for renal function.

Morton J. Kern, MD, of the University of California, Irvine (Irvine CA), said the study adds to the growing trend of bivalirudin use. “There is a major sense of the limitations of heparin in PCI patients,” he said. “Several prominent opinion leaders have favored bivalirudin in all circumstances over heparin whenever possible.” He added that the current paper, along with other recent research, will likely lead to a recommendation of bivalirudin over heparin in these patients.

Dr. Gurm agreed. “I think all things being equal, bivalirudin should be the preferred drug in patients with renal dysfunction, since these patients are more likely to bleed, and use of bivalirudin is associated with dramatically lower bleeding in this population,” he said.

Study Details

Access site was primarily femoral (98%) and about half of the population had some form of renal dysfunction; 19,618 patients (30%) had stage II CKD; 12,087 (19%) had stage III CKD, and 1,092 (1.7%) had stage IV CKD.

 

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Source:
Perdoncin E, Zhang M, Riba A, et al. Impact of worsening renal dysfunction on the comparative efficacy of bivalirudin and platelet glycoprotein IIb/IIIa inhibitors: Insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Circ Cardiovasc Interv. 2013;Epub ahead of print.

 

 

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