A study has examined the efficacy and bleeding outcomes of Cangrelor ( Kengrexal ) in patients in the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [ PCI ] ) who underwent percutaneous coronary intervention with Bivalirudin ( Angiox / Angiomax ).
Cangrelor is a potent intravenous P2Y12 inhibitor with rapid onset and offset.
In the CHAMPION PHOENIX, Cangrelor compared with Clopidogrel ( Plavix ) significantly reduced 48-h ischemic events including stent thrombosis, without increasing major bleeding.
Bivalirudin has demonstrated ischemic outcomes similar to those with Heparin plus glycoprotein IIb/IIIa inhibition, with reduced bleeding but increased early stent thrombosis.
In the modified intent-to-treat population, 2,059 patients ( 18.8% ) received Bivalirudin, with 1,014 patients in the Cangrelor treatment arm and 1,045 in the Clopidogrel treatment arm.
At 48 h, the primary endpoint of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis was lower with Cangrelor versus Clopidogrel ( 48 [ 4.7% ] vs 70 [ 6.7% ]; odds ratio, OR=0.68, p = 0.047 ).
Death was similar in both arms ( 2 [ 0.2% ] vs 2 [ 0.2% ] ).
Myocardial infarction was reduced by Cangrelor ( 37 [ 3.6% ] vs 59 [ 5.6% ]; OR=0.63, p = 0.03 ), as was death / myocardial infarction ( 39 [ 3.8% ] vs 61 [ 5.8% ]; OR=0.65, p = 0.04 ).
Cangrelor was associated with a nonsignificant trend toward less stent thrombosis ( 7 [ 0.7% ] vs 15 [ 1.4% ]; OR=0.48, p = 0.10 ), which was evident within 2 hours after percutaneous coronary intervention ( p = 0.057 ).
GUSTO ( Global Use of Strategies to Open Occluded Arteries ) severe bleeding was similar in both arms ( 2/1,021 [ 0.2% ] vs 2/1,055 [ 0.2% ] ) as were other bleeding definitions and transfusions.
Efficacy and safety results were consistent in patients with stable angina, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction ( p for interaction: 0.62 and 0.29 ).
In conclusion, Cangrelor may offer an attractive benefit risk profile when used in combination with Bivalirudin. ( Xagena )
White HD et al, JACC Cardiovasc Interv 2015; Epub ahead of print