Consistent Reduction in Peri-Procedural Myocardial Infarction with Cangrelor as Assessed by Multiple Definitions: Findings from CHAMPION PHOENIX
Background—Cangrelor is an intravenous P2Y12 inhibitor approved to reduce peri-procedural ischemic events in patients undergoing percutaneous coronary intervention (PCI) not pretreated with a P2Y12 inhibitor.
Methods—A total of 11,145 patients were randomized to cangrelor or clopidogrel in the CHAMPION PHOENIX trial. We explored the effects of cangrelor on MI using different definitions and performed sensitivity analyses on the primary endpoint of the trial.
Results—A total of 462 patients (4.2%) undergoing PCI had a MI as defined by the 2nd universal definition. The majority of these MIs were Type 4a (n=433, 93.7%). Treatment with cangrelor reduced the incidence of myocardial infarction at 48 hours (3.8% vs. 4.7%; OR 0.80; 95% confidence interval [CI], 0.67-0.97; p=0.02). When the SCAI definition of peri-procedural MI was applied to potential ischemic events, there were fewer total MIs (n=134); however, the effects of cangrelor on MI remained significant (OR, 0.65; 95% CI, 0.46-0.92; p=0.01). Similar effects were seen when evaluating the effects of cangrelor on MIs with peak CK-MB ≥ 10x ULN (OR, 0.64; 95% CI, 0.45-0.91) and those with peak CK-MB ≥10x ULN, ischemic symptoms, or ECG changes (OR, 0.63; 95% CI, 0.48-0.84). MIs defined by any of these definitions were all associated with increased risk of death at 30 days. Treatment with cangrelor reduced the composite endpoint of death, MI (SCAI definition), ischemia-driven revascularization, or ARC-definite stent thrombosis (1.4% vs. 2.1%; OR, 0.69; 95% 0.51-0.92).
Conclusions—MI in patients undergoing PCI, regardless of definition, remains associated with increased risk of death in the current era. Cangrelor, when compared with clopidogrel, significantly reduces MI, irrespective of the definition.
Clinical Trial Registration—clinicaltrials.gov; NCT01156571
- Received December 14, 2015.
- Revision received June 26, 2016.
- Accepted July 8, 2016.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.