KENGREAL is specifically designed as an adjunct to PCI.1,2 See how it performed vs clopidogrel in the phase III pivotal trial CHAMPION PHOENIX.
As an adjunct to PCI, KENGREAL significantly reduced the primary composite endpoint events of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis at 48 hours vs clopidogrel in an all-comer PCI patient population.
CHAMPION PHOENIX was a randomized, double-blind, placebo-controlled, phase III trial in 11,145 patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy. Patients received a bolus and infusion of cangrelor or a loading dose of 600 mg or 300 mg of clopidogrel.
mITT=modified intention-to-treat.
*The mITT population is all randomized subjects who received at least one dose of study drug and underwent the index PCI procedure.
mITT=modified intention-to-treat.
*The mITT population is all randomized subjects who received at least one dose of study drug and underwent the index PCI procedure.
mITT=modified intention-to-treat.
*The mITT population is all randomized subjects who received at least one dose of study drug and underwent the index PCI procedure.
†Based on logistic model adjusted for loading dose and baseline patient status for primary endpoint.
Note: If a subject had more than one event at 48 hours, then worst outcome counted (death>MI>IDR>ST).
mITT=modified intention-to-treat.
*The mITT population is all randomized subjects who received at least one dose of study drug and underwent the index PCI procedure.
Note: The figure presents effects in various subgroups, most of which are baseline characteristics and most of which were prespecified (patient presentation and weight were not prespecified subgroups). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be overinterpreted.
This analysis omitted 2 subcomponent events from the primary endpoint of lesser clinical significance:
mITT=modified intention-to-treat.
*The mITT population is all randomized subjects who received at least one dose of study drug and underwent the index PCI procedure.
†SCAI MI: CK-MB ≥10X ULN, or CK-MB ≥5X ULN with new Q waves or new LBBB.
‡ARC-ST defined according to the ARC definition.
ARC=Academic Research Consortium; CK-MB=creatine kinase MB isoenzyme; MI=myocardial infarction;
SCAI=Society for Cardiovascular Angiography and Interventions; ST=stent thrombosis.
Note: If a subject had more than one event at 48 hours, then worst outcome counted (death>SCAI MI>IDR>ARC-ST).
*Safety population is randomized subjects who received at least one dose of study drug.
†lntracranial hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment.
‡Requiring blood transfusion but not resulting in hemodynamic compromise.
§All other bleeding not included in severe or moderate.
‖Any intracranial hemorrhage, or any overt bleeding associated with a reduction in hemoglobin of ≥5 g/dL (or when hemoglobin is not available, an absolute reduction in hematocrit ≥15%).
¶Any overt sign of bleeding (including observation by imaging techniques) that is associated with a reduction in hemoglobin of ≥3 g/dL and <5 g/dL (or, when hemoglobin is not available, an absolute reduction in hematocrit of ≥9% and <15%).
GUSTO=GIobal Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries;
TIMI=Thrombolysis in Myocardial Infarction.
Results should be interpreted with caution and with considerations of study limitations; further research may be warranted.
*Data derived represents a post hoc supplemental analysis in which the study was powered for superiority at the 48-hour time frame. SCAI MI: CK-MB ≥10X ULN, or CK-MB ≥5X ULN with new Q waves or new LBBB. ARC-ST defined according to the ARC definition.
†Time 0 represents the start of PCI. KENGREAL for injection was administered at the time of PCI. Clopidogrel oral 300 mg or 600 mg was administered shortly before PCI or shortly afterward in patients randomized to clopidogrel.
ARC, Academic Research Consortium; CK‑MB, creatine kinase MB isoenzyme; IDR, ischemia-driven revascularization; LBBB, left bundle branch block; MI, myocarial infarction; SCAI, Society for Cardiovascular Angiography and Interventions; ST, stent thrombosis; ULN, upper limit of normal.
Consider KENGREAL when treating complex lesions
KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding.
KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.
Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL® than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
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