NCDR Study Assesses Bivalirudin vs. Heparin in STEMI Patients Undergoing Transradial Primary PCI

In patients undergoing transradial primary PCI for ST elevation myocardial infarction (STEMI), there was no significant difference in the rate of a composite of death, myocardial infarction or stroke whether they were anticoagulated with bivalirudin vs. heparin, according to a study published May 17 in JACC: Cardiovascular Interventions.

Ion S. Jovin, MD, FACC, et al., looked at 67,368 patients with STEMI who underwent transradial primary PCI between 2009 and 2015 in ACC's CathPCI Registry. Of the total patient sample group, 29,660 received bivalirudin, while 37,708 received heparin. The two groups also had similar mean ages and percentage of men (60.3 and 60.4 years; 74.9 and 75 percent, respectively).

The unadjusted comparison showed "no significant difference" in the rate of the composite endpoint of death, myocardial infarction, or stroke (4.6 percent vs. 4.7 percent; p = 0.47) and a "significantly higher rate" of acute stent thrombosis (1.00 percent vs. 0.60 percent; p < 0.001) with bivalirudin compared with heparin.

After making adjustments for multiple variables and a propensity score, results showed the odds ratio of the composite endpoint of death, myocardial infarction, or stroke for bivalirudin vs. heparin was 0.95 (95 percent confidence interval [CI]: 0.87 to 1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95 percent CI: 1.73 to 2.57) for bivalirudin vs. heparin. Major bleeding rates were not significantly different.

"Our sensitivity analysis provides some insights into direct comparison of bivalirudin and heparin when GPIIb/IIIa inhibitors are forced of the equation and suggest that in the direct comparison bivalirudin may have superior outcomes," says Jovin. "However, our study showed that in the real world over a third of the patients with STEMI undergoing transradial PCI who receive heparin and about a fifth of patients who receive bivalirudin also receive GPIIb/IIIa inhibitors."

The authors explain that while the data is consistent with that found in similar contemporary studies, there were contradistinctions between the various study results in regards to PCI approach type. As a result, moving forward, the authors suggest a randomized trial in patients treated exclusively with transradial primary PCI and anticoagulated with bivalirudin vs. heparin. They also believe a cost-effectiveness analysis comparing the two anticoagulants may benefit practitioners and hospitals making anticoagulation decisions.

In a related editorial comment, Harold L. Dauerman, MD, FACC, notes that "If we really want to know whether bivalirudin is needed in radial-based primary PCI, we need to repeat [the HEAT-PPCI trial]." He explains that "given the growth of radial primary PCI in the United States, a trans-Atlantic trial of radial access primary PCI is possible..."

"Until this trial is run, the large national registries will show us how our nations compare but tell us little about who is actually right," he adds.

Clinical Topics: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Anticoagulants, Confidence Intervals, Cost-Benefit Analysis, Heparin, Hirudins, Middle Aged, Myocardial Infarction, Odds Ratio, Peptide Fragments, Platelet Glycoprotein GPIIb-IIIa Complex, Propensity Score, Registries, Stents, Stroke, Thrombosis, Angiography, National Cardiovascular Data Registries, CathPCI Registry


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