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Death, CV events similar with bivalirudin, heparin for radial PCI
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In patients undergoing transradial PCI for STEMI, there was no significant difference in the rate of composite of death, MI and stroke whether patients received anticoagulation with bivalirudin or unfractionated heparin, according to a study published in JACC: Cardiovascular Interventions.
Researchers analyzed data from the National Cardiovascular Data Registry (NCDR) CathPCI Registry of 67,368 patients with STEMI who underwent primary PCI via radial access at 1,584 U.S. sites from 2009 to 2015. Of those, 29,660 patients received bivalirudin and 37,708 received heparin. The groups had a similar mean age (60 years) and were primarily male (75%).
According to the findings, the unadjusted rate of the composite endpoint of death, MI or stroke was 4.6% in the bivalirudin group vs. 4.7% in the heparin group (P = .47).
The rate of acute stent thrombosis was significantly higher with bivalirudin compared with heparin (1% vs. 0.6%; P < .001).
When the researchers adjusted for multiple variables, the OR of the composite endpoint for bivalirudin vs. heparin was 0.95 (95% CI, 0.87-1.05) and the OR for acute stent thrombosis was 2.11 (95% CI, 1.73-2.57).
Rates of major bleeding were similar between the anticoagulation groups.
Further, “our sensitivity analysis provides some insights into direct comparisons of bivalirudin and heparin when glycoprotein IIb/IIIa inhibitors are forced out of the equation, and suggests that in the direct comparison bivalirudin may have superior outcomes,” Ion S. Jovin, MD, ScD, FACC, medical director of the Cardiac Catheterization Laboratories at McGuire Veterans Affairs Medical Center and associate professor of medicine at Virginia Commonwealth University, said in a press release. “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 glycoprotein IIb/IIIa inhibitors.”
Jovin and colleagues noted that the results of the NCDR study are consistent with data from contemporary studies of patients with ACS and STEMI.
“Recent studies in which PCI was performed predominantly via radial access did not show bivalirudin to be superior to heparin,” the researchers wrote in JACC: Cardiovascular Interventions.
Trials examining this controversy include HEAT-PPCI, BRIGHT, MATRIX, HORIZONS AMI, the British Cardiovascular Intervention Society registry, and the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
In the context of the current data and previous trials, “we are left struggling for answers yet again,” Harold L. Dauerman, MD, from the University of Vermont College of Medicine, Burlington, wrote in an accompanying editorial.
“Given the growth of radial primary PCI in the United States, a trans-Atlantic trial of radial access primary PCI is possible: an international, multicenter, 1,000-patient trial comparing radial-access primary PCI patients treated with heparin only vs. bivalirudin, a < 20% glycoprotein inhibitor bailout rate in both arms, and routine use of a 2-hour post-intervention infusion at the PCI dose. Does bivalirudin still increase stent thrombosis risk? Does bivalirudin reduce bleeding complications compared with heparin only in radial-access patients? Does a heparin-only strategy confer a mortality risk? 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,” Dauerman wrote.
The researchers suggested that a randomized trial in patients treated exclusively via transradial primary PCI and anticoagulation with bivalirudin vs. heparin, as well as a cost-effectiveness analysis comparing heparin vs. bivalirudin, may provide further insight into the optimal anticoagulation strategy in these patients.– by Katie Kalvaitis
Disclosure: Dauerman reports consulting for and receiving grants from Boston Scientific, Edwards Lifesciences and Medtronic. Jovin reports no relevant financial disclosures. See the full study for a list of the other researchers’ relevant financial disclosures.
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