Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX
Authors: Cavender Matthew A. , Harrington Robert A. , Stone Gregg W. , Steg Ph. Gabriel , Gibson C. Michael , Hamm Christian W. , Price Matthew J. , Lopes Renato D. , Leonardi Sergio , Deliargyris Efthymios N. , Prats Jayne , Mahaffey Kenneth W. , White Harvey D. , Bhatt Deepak L. , Harrington Robert A. , Huber Kurt , Lima Valter C. , Jorgova-Makedonska Julia B. , Widimský Petr , Kobulia Bondo , Radke Peter W. , Bramucci Ezio , Witkowski Adam , Shlyakhto Evgeny , Van de Werf Frans , Faxon David P. , Ohman E. Magnus , Verheugt Freek W.A. , Weaver W. Douglas , Tijssen Jan G.P. , Wilson Matthew , Mangum Stacey , Melloni Chiara , Brennan Matthew J. , Tricoci Pierluigi , Harrison Robert , Barros Pedro , Armaganijan Luciana , Anderson Monique , Bagai Akshay , Généreux Philippe , Brener Sorin J. , LaSalle Laura , Benzer Werner , Delle-Karth Georg , Huber Kurt , Leisch Franz , Abdalla Saad Jamil , Abizaid Alexandre , Augusto Formiga Areas Carlos , Ribeiro Expedito E. , Rossi Dos Santos Fabio , Tadeu Tumelero Rogerio , Vieira Botelho Roberto , Atzev Borislav , Boichev Boicho , Grigorov Georgi , Penkov Nikolay , Petrov Ivo , Zehirov Boris , Cervinka Pavel , Coufal Zdenek , Hajek Petr , Horak David , Kala Petr , Kmonicek Petr , Kocka Viktor , Mrozek Jan , Simek Stanislav , Sitar Jan , Stasek Josef , Tousek Frantisek , Chapidze Gulnara , Emukhvari Nodar , Khabeishvili George , Mamatsashvili Merab , Shaburishvili Tamaz , Behrens Steffen , Darius Harald , Dissmann Martin , Fichtlscherer Stephan , Franz Wolfgang , Geisler Tobias , Genth-Zotz Sabine , Goldmann Britta , Heuer Hubertus , Hoffmann Stefan , Mugge Andreas , Poerner Tudor , Radke Peter , Richardt Gert , Stellbrink Christoph , Werner Nikos , Bramucci Ezio , De Servi Stefano , Galasso Gennaro , Menozzi Alberto , Musumeci Giuseppe , Picchi Andrea , Presbitero Patrizia , Devlin Gerard , Sasse Alexander , Scott Douglas , Stewart Ralph , Andrzej Szyszka , Dubaniewicz Witold , Gasior Zbigniew , Kasprzak Jaroslaw , Kleinrok Andrzej , Kornacewicz-Jach Zdzislawa , Rynkiewicz Andrzej , Sosnowski Cezary , Targonski Radoslaw , Trebacz Jaroslaw , Witkowski Adam , Zinka Elzbieta , Barbarash Olga , Dovgalevsky Yakov , Gordeev Ivan , Kalinina Svetlana , Kosmachova Elena , Markov Valentin , Pavlov Prokhor , Shalaev Sergey , Shogenov Zaur , Sukmanova Irina , Vasilieva Elena , Yakovlev Alexey , Boonbaichaiyapruck Sarana , Chamnarnphol Noppadol , Kaewsuwanna Pinij , Kuanprasert Srun , Piyayotai Dilok , Amine Maged , Angiolillo Dominick , Arif Imran , Blankenship James , Brilakis Emmanouil , Chan Michael , Cinderella Joseph , Davis Brent , Devireddy Chandanreddy , Dorogy Mark , Douglas John , Ferrier Norman , Fisher Daniel , Foster Robert , French William , Galla John , Gimple Lawrence , Gogia Harinder , Gogo Prospero , Gollapudi Raghava , Gruberg Luis , Hermiller James , Heuser Richard , Iwaoka Robert , Jafar Zubair , Kimmelstiel Carey , Kinlay Scott , Leggett James , Leimgruber Pierre , Letts Dustin , Lipsitt Michael , Low Reginald , Martinez-Arraras Joaquin , Mayhew Marc , McLaurin Brent , McWhirter Paul , Mirza Ayoub , Negus Brian , Nygaard Thomas , O’Riordan William , Paulus Richard , Petersen John , Picon Hector , Picone Mark , Rivera Ernesto , Rizik David , Rizik David , Rodriguez Arsenio , Saucedo Jorge , Scott J. Christopher , Sethi Virender , Shroff Adhir , Siegel Craig , Spriggs Douglas , Steinberg Daniel , Stillabower Michael , Stuckey Thomas , Suarez Jose , Tauth Jeffrey , Temizer Dogan , Vidovich Mladen , Voeltz Michele , Waltman Jonathan , Wilensky Michael 
Published: December 2021

Background:

Thrombotic events are reduced with cangrelor, an intravenous P2Y
12
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.