Meta-Analysis Evaluates Various Doses of Bivalirudin Infusion After Primary PCI
August 21, 2017—The Society for Cardiovascular Angiography and Interventions (SCAI) recently announced findings from a study examining the efficacy of various bivalirudin doses after percutaneous coronary intervention (PCI) on net adverse clinical events (NACEs) and mortality. Rahman Shah, MD, et al published the study in Catheterization and Cardiovascular Interventions (2017; 90:196–204).
According to SCAI, patients recovering from PCI with bivalirudin are at a lower risk of bleeding, but also have an increased risk of acute stent thrombosis. Previous research concluded that continuing bivalirudin infusion at full doses for 4 hours after PCI eliminates acute thrombosis risk while maintaining the bleeding benefit. The results of the current study determined that full-dose bivalirudin infusion after PCI for 4 hours is also associated with improved NACEs and all-cause mortality.
SCAI reported that investigators analyzed randomized clinical trials (RCTs) to gather results and separated the data into two groups: patients treated with bivalirudin and patients treated with unfractionated heparin (UFH). The bivalirudin arm was divided based on bivalirudin dosage after PCI: the "Biv-Full" group received 1.75 mg/kg/h, the "Biv-Low" group received 0.25 mg/kg/h, and the "Biv-No" group received none.
Six RCTs and 16,842 patients met the criteria for inclusion. Bivalirudin exhibited an improvement in 30-day all-cause mortality by 35% and cardiac mortality by 32%, but did not yield a NACE rate better than that achieved with UFH. Subgroup analysis showed the Biv-Full group had a 46% lower NACE rate and 47% lower all-cause mortality rate than UFH. These effects were not seen in the other two groups. The Biv-Full group yielded the best treatment efficacy overall.
Dr. Shah commented in the SCAI announcement, “For many years, heparin was the only anticoagulant available for primary PCI. However, once a lower risk of bleeding was found with bivalirudin, many cardiologists started using it preferentially over heparin. Once the acute stent thrombosis risk with bivalirudin was well-publicized, many physicians returned to using heparin. With this research, we show that for patients undergoing primary PCI, bivalirudin (with 4-hour after PCI infusion at full dose) might be the safest and most effective anticoagulation because it is associated not only with decreased risk of bleeding and net adverse clinical event events, but also improved mortality.”
Dr. Shah continued, “Our findings are consistent with recent changes to the bivalirudin package insert by the US Food and Drug Administration. Therefore, if bivalirudin-based anticoagulation is used during primary PCI, it should be continued for at least 4 hours (at full dose) after PCI. Ongoing trials such as SWEDEHEART, which mandates full-dose bivalirudin after PCI in patients with acute coronary syndrome, will provide additional insights into this topic.”