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Bivalirudin vs. Heparin for Primary PCI in STEMI
Study Questions:
What are the outcomes of patients with acute STEMI who underwent primary PCI through the transradial approach and who were anticoagulated with either bivalirudin or with heparin with or without glycoprotein (GP) IIb/IIIa inhibitors?
Methods:
The investigators compared outcomes in patients with STEMI included in the National Cardiovascular Data Registry CathPCI database from 2009 to 2015, who underwent primary PCI via radial access and who were anticoagulated with bivalirudin or heparin. The primary endpoint was a composite of in-hospital death, myocardial infarction (MI), and stroke. A hierarchical multivariate model clustered by site with a random intercept was used to assess the impact of bivalirudin (vs. heparin) on outcomes.
Results:
The sample included 67,368 patients, of whom 29,660 received bivalirudin and 37,708 received heparin. The two groups of patients did not differ significantly in their mean age or percentage of men. The unadjusted comparison showed no significant difference in the rate of the composite endpoint of death, MI, or stroke (4.6% vs. 4.7%; p = 0.47) and a significantly higher rate of acute stent thrombosis (1.00% vs. 0.60%; p < 0.001) with bivalirudin compared with heparin. After adjusting for multiple variables, including a propensity score reflecting the probability of receiving bivalirudin, the odds ratio of the composite endpoint of death, MI, or stroke for bivalirudin versus heparin was 0.95 (95% confidence interval, 0.87-1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95% confidence interval, 1.73-2.57) for bivalirudin versus heparin. Major bleeding rates were not significantly different.
Conclusions:
The authors concluded that in patients undergoing primary PCI via transradial access anticoagulated with bivalirudin or heparin, there was no difference in the composite endpoint of death, MI, or stroke.
Perspective:
This study reports that in a large cohort of real-world patients, there was no significant difference in the rate of a composite of death, MI, and stroke in patients undergoing primary transradial PCI for STEMI whether they were anticoagulated with bivalirudin or unfractionated heparin. The current guidelines give both bivalirudin and heparin a Class I indication for anticoagulation of patients with STEMI undergoing primary PCI, and these data support the equipoise of the two anticoagulant agents in patients undergoing primary PCI. Whereas a prospective randomized trial in patients treated via transradial primary PCI and anticoagulated with bivalirudin versus heparin may help provide additional insight in decision making, such a trial is unlikely to be conducted, given that several large recent trials such as HEAT-PPCI, MATRIX, and BRAVE 4 have not shown superiority of bivalirudin over heparin for PCI.
Keywords: Acute Coronary Syndrome, Anticoagulants, Antithrombins, CathPCI Registry, Heparin, Hospital Mortality, Myocardial Infarction, Peptide Fragments, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Stents, Stroke, Thrombosis
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