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Bivalirudin vs. Heparin for STEMI PCI Patients
Study Questions:
What are the temporal trends and comparative effectiveness of bivalirudin versus unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI)?
Methods:
The authors assessed trends in anticoagulant use among 513,775 PCIs for STEMI from July 2009 through December 2014 within the National Cardiovascular Data Registry (NCDR) CathPCI Registry. An instrumental variable analysis was performed comparing bivalirudin with UFH, using operator preference for bivalirudin as the instrument. Primary outcomes were in-hospital bleeding and mortality.
Results:
Bivalirudin use increased from 29% in 2009 to 45% through 2013, followed by a decline to 37% in 2014. Glycoprotein inhibitors (GPIs) were used in 74.7% of UFH PCIs versus 26.5% of bivalirudin PCIs. In unadjusted analyses, bivalirudin was associated with decreased bleeding (risk difference [RD], -4.2%; p < 0.001) and mortality (RD, -0.84%; p < 0.001), but a greater likelihood of stent thrombosis (0.92% with bivalirudin vs. 0.51% with UFH; RD, 0.41% p < 0.001). After instrumental variable analyses, bivalirudin remained associated with reduced bleeding (RD, -3.75%; p < 0.001), increased stent thrombosis (RD, 0.43; p < 0.001), but not mortality (RD, -0.10%; p = 0.280). The higher rate of GPI use with UFH was responsible for more than half of bivalirudin’s bleeding reduction (GPI-adjusted RD, -1.57%; p < 0.001). Bleeding reductions were negligible for transradial PCI (RD, -0.11%; p = 0.842).
Conclusions:
After an initial increase, there has been a recent decline in use of bivalirudin for PCI for STEMI in the United States.
Perspective:
This study adds to the growing data on comparative effectiveness of bivalirudin versus heparin in STEMI PCI. The antibleeding benefits of bivalirudin over heparin are of small magnitude in the absence of GPI use, carry an increased risk of stent thrombosis, and are absent in patients undergoing radial PCI (Cavendar MA, Sabatine MS. Lancet 2014;384:599-606). Given the significant cost difference between bivalirudin and heparin, heparin should be the preferred agent for STEMI PCI except in patients at extreme risk of bleeding.
Keywords: Acute Coronary Syndrome, Anticoagulants, Antithrombins, CathPCI Registry, Glycoproteins, Hemorrhage, Heparin, Myocardial Infarction, National Cardiovascular Data Registries, Percutaneous Coronary Intervention, Stents, Thrombosis
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