Adverse Outcomes Compared for Bivalirudin, Unfractionated Heparin in PCI

When compared to bivalirudin, higher bleeding complications and all-cause mortality were seen with unfractionated heparin among patients undergoing PCI.

WASHINGTON, DC—When compared to bivalirudin, higher bleeding complications and all-cause mortality were seen with unfractionated heparin, reported Perwaiz M. Meraj, from Northwell Health, Manhasset, NY, at the ACC.17 Scientific Session. 

In patients undergoing percutaneous coronary intervention (PCI), bivalirudin has demonstrated superiority over unfractionated heparin but “more recent data suggests that the benefit may not be present due to modern day PCI techniques ad oral P2Y12 pharmacology,” said Meraj. The study authors aimed to determine if bivalirudin was superior to unfractionated heparin monotherapy in modern day real-world PCI. 

They identified 15,440 patients from the CathPCI database across New York City multicenter tertiary care centers from January 2011 to April 2016. Study patients had PCI using radial or femoral access and received either heparin (n=5,729) or bivalirudin (n=9,711) monotherapy.

“Primary outcome was death on discharge, while secondary outcomes were myocardial infarction (MI), stroke, tamponade, congestive heart failure (CHF), cardiogenic shock, new dialysis requirement, red blood cell transfusion and bleeding within 72 hours.” 

The data showed the unfractionated heparin group had higher rates of the primary outcome of all-cause mortality at discharge compared to the bivalirudin group (40 [0.70%] vs. 32 [0.33%]; P=0.001). The incidence of cardiogenic shock (0.80% vs. 0.61%), CHF (1.57% vs. 1.32), stroke (0.23% vs. 0.19%), and tamponade (0.19% vs. 0.07%) were all higher in the heparin group vs. the bivalirudin group.

Secondary outcomes of bleeding (104 [1.82%] vs. 144 [1.48%]; P=0.112) and transfusion requirement (132 [2.30%] vs. 207 [2.13%]; P=0.481) were also higher in the unfractionated heparin group vs. the bivalirudin group, the authors noted. In addition, the rates of MI were higher with use of bivalirudin. 

Meraj concluded, “The findings of higher bleeding complications and all cause mortality with unfractionated heparin is consistent with the findings from prior sentinel bivalirudin trials, however this is in a population undergoing modern day therapy. The acuity of the patient population is demonstrable with the use of GpIIb/IIIa inhibitors and high numbers of ACS patients.”