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VALIDATE-SWEDEHEART: Bivalirudin not superior to heparin in PCI for MI
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Patients with MI undergoing PCI had similar outcomes regardless of whether they were anticoagulated with bivalirudin or heparin, according to new data from the VALIDATE-SWEDEHEART study published in The New England Journal of Medicine.
In order to more clearly define the proper treatment strategy among patients with acute MI undergoing PCI, David Erlinge, MD, PhD, from the department of cardiology, clinical sciences, Lund University, Skåne University Hospital, Lund, Sweden, and colleagues conducted a multicenter, randomized, registry-based, open-label clinical trial.
All patients had STEMI or non-STEMI and underwent PCI while receiving treatment with potent P2Y12 inhibitors — cangrelor (Kengreal, The Medicines Company), prasugrel (Effient, Daiichi Sankyo/Eli Lilly) or ticagrelor (Brilinta, AstraZeneca) — without the planned use of glycoprotein IIb/IIIa inhibitors.
“The use of more potent P2Y12 inhibitors has further improved clinical outcomes over those seen with the use of clopidogrel, which was the previous standard treatment option for such patients,” the researchers wrote. “The goal of anticoagulant management is to balance the risk of thrombotic complications, such as reinfarction and stent thrombosis, with the risk of bleeding complications.”
A total of 6,006 patients were randomly assigned to bivalirudin or heparin treatment during PCI, which was performed primarily with transradial access.
No difference in outcomes
The primary endpoint of the study was a composite of all-cause death, MI or major bleeding at 180 days.
According to the researchers, a primary endpoint event occurred in 12.3% of the patients in the bivalirudin group and in 12.8% in the heparin group (HR = 0.96; 95% CI, 0.83-1.1). The results were consistent across major subgroups, including those with STEMI and those with non-STEMI.
Other outcomes were as follows:
- MI: bivalirudin, 2%; heparin, 2.4%; HR = 0.84; 95% CI, 0.6-1.19
- Major bleeding: bivalirudin, 8.6%; heparin, 8.6%; HR = 1; 95% CI, 0.84-1.19
- Definite stent thrombosis: bivalirudin, 0.4%; heparin, 0.7%; HR = 0.54; 95% CI, 0.27-1.1; and
- Death: bivalirudin, 2.9%; heparin, 2.8%; HR = 1.05; 95% CI, 0.78-1.41.
Ongoing uncertainties
According to an accompanying editorial from Gregg W. Stone, MD, director of cardiovascular research and education for Columbia University Medical Center/NewYork-Presbyterian Hospital, co-director of medical research and education at the Cardiovascular Research Foundation and a member of the Cardiology Today’s Intervention Editorial Board, more detailed data are needed to address ongoing uncertainties in comparisons of anticoagulation strategies.
“A meta-analysis of six randomized trials conducted before VALIDATE-SWEDEHEART that compared bivalirudin therapy with heparin therapy [in] patients with STEMI showed that bivalirudin was associated with a lower rate of major bleeding, a higher rate of stent thrombosis and an 18% lower 30-day mortality than was heparin. … Previous trials involving patients with [non-STEMI] showed rates of death, MI and stent thrombosis were similar with bivalirudin and heparin, although they showed lower rates of bleeding with bivalirudin than with heparin,” he wrote. “Thus, even after VALIDATE-SWEDEHEART, there is no definitive answer to the question of whether to use bivalirudin or heparin during PCI.”
The findings were also presented at the European Society of Cardiology Congress. – by Dave Quaile
Disclosure: The study was supported in part by AstraZeneca and The Medicines Company. Erlinge reports he receives personal fees from AstraZeneca and The Medicines Company. Please see the full study for a list of the other authors’ relevant financial disclosures. Stone reports financial ties with Abbott Vascular, Ablative Solutions, Aria, Backbeat Medical, Biostar family of funds, Cagent, Caliber, Claret Medical, Guided Delivery Systems, Lupin Pharmaceuticals, Matrizyme, MedFocus family of funds, Medical Development Technologies, Micardia, Miracor, Neovasc, Qool Therapeutics, Reva, Sirtex, St. Jude Medical, TherOx, Topay, Valfix, Vascular Dynamics and V-wave.
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