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Randomized Controlled Trial
. 2022 Jan;15(1):e010390.
doi: 10.1161/CIRCINTERVENTIONS.120.010390. Epub 2021 Dec 17.

Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

Matthew A Cavender  1 , Robert A Harrington  2 , Gregg W Stone  3 , Ph Gabriel Steg  4   5 , C Michael Gibson  6 , Christian W Hamm  7 , Matthew J Price  8 , Renato D Lopes  9 , Sergio Leonardi  10 , Efthymios N Deliargyris  11 , Jayne Prats  12 , Kenneth W Mahaffey  2 , Harvey D White  13 , Deepak L Bhatt  14 ; CHAMPION PHOENIX Investigators*
Collaborators, Affiliations
Randomized Controlled Trial

Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

Matthew A Cavender et al. Circ Cardiovasc Interv. 2022 Jan.

Abstract

Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention).

Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis).

Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64-0.90], P=0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40-0.80], P=0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71-1.93]; P=0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37-5.40]; P=0.62).

Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01156571.

Keywords: P2Y12 receptor antagonist; coronary artery disease; myocardial infarction; percutaneous coronary intervention; thrombosis.

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Figures

Figure 1.
Figure 1.
Landmark analyses of composite ischemic end points. Landmark analysis of the (A) incidence of death, myocardial infarction, ischemia driven revascularization, or stent thrombosis at 2 hr following randomization and after 2 hr and (B) death, myocardial infarction [Society of Angiography and Intervention], ischemia driven revascularization, or Academic Research Consortium stent thrombosis at 2 hr following randomization and after 2 hr. HR indicates hazard ratio.
Figure 2.
Figure 2.
Landmark analyses of individual ischemic end points. Landmark analysis of the incidence of (A) myocardial infarction (Society of Angiography and Intervention Definition) before and after 2 hr postrandomization and (B) stent thrombosis at 2 hr. HR indicates hazard ratio.
Figure 3.
Figure 3.
Distribution and type of ischemic events post-percutaneous coronary intervention in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). ARC indicates Academic Research Consortium; IDR, ischemia driven revascularization; MI, myocardial infarction; SCAI, Society of Angiography and Intervention; and ST, stent thrombosis.
See this image and copyright information in PMC

Comment in

References

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