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Meta-analysis: Bivalirudin vs. heparin increases risk for MI, stent thrombosis, decreases bleeding
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Results from a new meta-analysis have found that an anticoagulation regimen of bivalirudin vs. heparin increases the rate of MI and stent thrombosis while decreasing the risk for major bleeding in patients undergoing PCI. The extent of bleeding reduction with bivalirudin was dependent on concomitant glycoprotein IIb/IIIa inhibitor use, according to the researchers.
“It can be challenging to wade through the seemingly disparate data in the literature. These findings should help clinicians make a more informed decision when selecting an anticoagulant to support coronary stenting in different types of patients by weighing the trade-offs between risks of thrombotic and bleeding complications,” Marc S. Sabatine, MD, MPH, senior study author with Brigham and Women's Hospital (BWH), Boston, said in a press release.
The study, which was published in The Lancet, included 16 randomized controlled trials, totaling 33,958 patients. The trials were culled from searches of Medline and Cochrane Library databases for trials evaluating bivalirudin (Angiomax, The Medicines Company) vs. heparin in patients planned for PCI.
The primary efficacy endpoint was MACE incidence at 30 days and the primary safety endpoint was major bleeding at 30 days. Death, MI, ischemia-driven revascularization and stent thrombosis were defined as secondary efficacy endpoints.
Overall, 2,422 patients experienced MACE and 1,406 had a major bleed. Patients in the bivalirudin-based anticoagulation regimen group had a higher rate of MACE compared with those given heparin (RR=1.09; P=.0204). This difference was primarily driven by increased rates of MI (RR=1.12; 95% CI, 1.03-1.23) and ischemia-driven revascularization (RR=1.16; 0.997-1.34) in the bivalirudin group; however, these differences did not affect mortality, which was similar between groups.
In addition, compared with heparin, bivalirudin increased the risk for stent thrombosis (RR=1.38; P=.0074), which the researchers attributed to an increase in acute STEMI cases in that group (RR=4.27; P<.0001). Conversely, bivalirudin reduced the risk for major bleeding compared with heparin (RR=0.62; P<.0001), although the magnitude of the reduction differed greatly (P<.0001) depending on whether glycoprotein IIb/IIIa inhibitors were used primarily in the heparin arm only (RR=0.53; P<.0001), provisionally in both arms (RR=0.78; P=.25) or planned in both arms (RR=1.07; P=.53).
These findings, Sabatine and Matthew A. Cavender, MD, MPH, study author also with BWH, wrote, should “serve as impetus to continue to investigate specific strategies to minimize thrombotic complications during PCI without substantially increasing the risk of bleeding. Prolonging bivalirudin infusion after PCI could decrease the risk of acute stent thrombosis; however, this strategy would need to be studied with rigorous clinical outcomes trials before being used.”
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