Outcomes with cangrelor versus clopidogrel on a background of bivalirudin: insights from the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI]).

Abstract

OBJECTIVES:

The aim of this study was to examine the efficacy and bleeding outcomes of cangrelor 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.

BACKGROUND:

Cangrelor is a potent intravenous P2Y12 inhibitor with rapid onset and offset. In the CHAMPION PHOENIX, cangrelor compared with clopidogrel 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.

METHODS:

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.

RESULTS:

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 h after percutaneous coronary intervention (p = 0.057). GUSTO (Global Use of Strategies to Open Occluded Arteries) severe bleeding was similar in both arms (2 of 1,021 [0.2%] vs. 2 of 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).

CONCLUSIONS:

Cangrelor may offer an attractive benefit risk profile when used in combination with bivalirudin.

• Authors: Harvey D White, Deepak L Bhatt, C Michael Gibson, Christian W Hamm, Kenneth W Mahaffey, Matthew J Price, Ph Gabriel Steg, Gregg W Stone, Bernardo Cortese, Michael Wilensky, Efthymios N Deliargyris, Tiepu Liu, Jayne Prats, Robert A Harrington
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 8 Issue 3 Pg. 424-433 (Mar 2015) ISSN: 1876-7605 [Electronic] United States
• PMID: 25703887 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anticoagulants
• Hirudins
• Peptide Fragments
• Platelet Aggregation Inhibitors
• Recombinant Proteins
• Adenosine Monophosphate
• cangrelor
• Clopidogrel
• Ticlopidine
• bivalirudin

Topics

• Adenosine Monophosphate (adverse effects, analogs & derivatives, therapeutic use)
• Aged
• Anticoagulants (adverse effects, therapeutic use)
• Chi-Square Distribution
• Clopidogrel
• Coronary Artery Disease (diagnosis, mortality, therapy)
• Coronary Thrombosis (etiology, prevention & control)
• Double-Blind Method
• Female
• Hemorrhage (chemically induced)
• Hirudins (adverse effects)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Myocardial Infarction (etiology, prevention & control)
• Odds Ratio
• Peptide Fragments (adverse effects, therapeutic use)
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Platelet Aggregation Inhibitors (adverse effects, therapeutic use)
• Recombinant Proteins (adverse effects, therapeutic use)
• Risk Factors
• Stents
• Ticlopidine (adverse effects, analogs & derivatives, therapeutic use)
• Time Factors
• Treatment Outcome