VALIDATE-SWEDEHEART: Bivalirudin vs. Heparin in STEMI, NSTEMI Patients Undergoing PCI

At 180 days, no significant difference in the rate of death, myocardial infarction (MI) or major bleeding was seen among patients with STEMI or NSTEMI who were undergoing percutaneous coronary intervention (PCI) and who received either bivalirudin or heparin treatment, according to data from VALIDATE-SWEDEHEART presented Aug. 27 at ESC Congress 2017 in Barcelona.

The study, the results of which were also published in the New England Journal of Medicine, compared bivalirudin with heparin monotherapy among 6,006 STEMI and NTEMI patients who were undergoing PCI in Sweden. PCI was predominantly performed using a radial approach and the majority of patients were receiving treatment with high-intensity platelet inhibitors. The primary endpoint was a composite of death from any cause, MI or major bleeding during a 180-day follow-up period.

Results showed that at 180 days a primary endpoint event had occurred in 12.3 percent of patients in the bivalirudin group (369 of 3,004 patients), compared to 12.8 percent in the heparin group (383 of 3,002 patients) (P=0.54). According to the study authors, these results were consistent across patients with STEMI and NSTEMI, as well as other major subgroups. Broken down by event, MI occurred in 2.0 percent of patients in the bivalirudin group, compared to 2.4 percent in the heparin group (P=0.33); major bleeding occurred in 8.6 percent of patients in both groups (P=0.98); definite stent thrombosis occurred in 0.4 percent of patients in the bivalirudin group, compared to 0.7  percent in the heparin group (P=0.09); and death occurred in 2.9 percent of those in the bivalirudin group, compared to 2.8 percent in the heparin group.

“In this investigator-initiated, registry-based, randomized clinical trial, we enrolled patients with acute coronary syndromes who were undergoing PCI and receiving treatment with aspirin and potent P2Y inhibitors, without the planned use of glycoprotein IIb/IIIa inhibitors,” researchers said. “The low rates of ischemic events overall and the absence of a significant between-group difference in event rates may have been influenced by the robust antithrombotic regimen used in the trial.”

In an accompanying editorial, Gregg W. Stone, MD, FACC, highlights several limitations to the study that make it difficult to definitively answer the question of whether to use bivalirudin or heparin during PCI. He notes that the principal investigators from each of the large-scale randomized trials comparing bivalirudin and heparin for MI, including VALIDATE-SWEDEHEART, have agreed to combine individual patient data from their respective studies into a single database, which “should provide robust evidence to guide decisions.” 

Keywords: ESC Congress, ESC2017, Platelet Aggregation Inhibitors, Heparin, Acute Coronary Syndrome, Aspirin, Myocardial Infarction, Hirudins, Platelet Glycoprotein GPIIb-IIIa Complex, Peptide Fragments, Percutaneous Coronary Intervention, Thrombosis, Stents

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