Impact of intraprocedural stent thrombosis during Percutaneous coronary intervention: Insights from the champion phoenix trial (clinical trial comparing Cangrelor to Clopidogrel standard of care therapy in subjects who require Percutaneous coronary intervention)

Philippe Généreux, Gregg W. Stone, Robert A. Harrington, C. Michael Gibson, Ph Gabriel Steg, Sorin J. Brener, Dominick J. Angiolillo, Matthew J. Price, Jayne Prats, Laura Lasalle, Tiepu Liu, Meredith Todd, Simona Skerjanec, Christian W. Hamm, Kenneth W. Mahaffey, Harvey D. White, Deepak L. Bhatt

Research output: Contribution to journalArticle

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Abstract

Objectives This study sought to evaluate the clinical impact of intraprocedural stent thrombosis (IPST), a relatively new endpoint. Background In the prospective, double-blind, active-controlled CHAMPION PHOENIX (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial, cangrelor significantly reduced periprocedural and 30-day ischemic events in patients undergoing percutaneous coronary intervention (PCI), including IPST. Methods An independent core laboratory blinded to treatment assignment performed a frame-by-frame angiographic analysis in 10,939 patients for the development of IPST, defined as new or worsening thrombus related to stent deployment at any time during the procedure. Adverse events were adjudicated by an independent, blinded clinical events committee. Results IPST developed in 89 patients (0.8%), including 35 of 5,470 (0.6%) and 54 of 5,469 (1.0%) patients in the cangrelor and clopidogrel arms, respectively (odds ratio: 0.65; 95% confidence interval: 0.42 to 0.99; p = 0.04). Compared to patients without IPST, IPST was associated with a marked increase in composite ischemia (death, myocardial infarction [MI], ischemia-driven revascularization, or new-onset out-of-laboratory stent thrombosis [Academic Research Consortium]) at 48 h and at 30 days (29.2% vs. 4.5% and 31.5% vs. 5.7%, respectively; p < 0.0001 for both). After controlling for potential confounders, IPST remained a strong predictor of all adverse ischemic events at both time points. Conclusions In the large-scale CHAMPION PHOENIX trial, the occurrence of IPST was strongly predictive of subsequent adverse cardiovascular events. The potent intravenous adenosine diphosphate antagonist cangrelor substantially reduced IPST, contributing to its beneficial effects at 48 h and 30 days. (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX]; NCT01156571).

Original languageEnglish (US)
Pages (from-to)619-629
Number of pages11
JournalJournal of the American College of Cardiology
Volume63
Issue number7
DOIs
StatePublished - Feb 25 2014
Externally publishedYes

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clopidogrel
Percutaneous Coronary Intervention
Standard of Care
Stents
Thrombosis
Clinical Trials
Therapeutics
cangrelor

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Généreux, Philippe ; Stone, Gregg W. ; Harrington, Robert A. ; Gibson, C. Michael ; Steg, Ph Gabriel ; Brener, Sorin J. ; Angiolillo, Dominick J. ; Price, Matthew J. ; Prats, Jayne ; Lasalle, Laura ; Liu, Tiepu ; Todd, Meredith ; Skerjanec, Simona ; Hamm, Christian W. ; Mahaffey, Kenneth W. ; White, Harvey D. ; Bhatt, Deepak L. / Impact of intraprocedural stent thrombosis during Percutaneous coronary intervention : Insights from the champion phoenix trial (clinical trial comparing Cangrelor to Clopidogrel standard of care therapy in subjects who require Percutaneous coronary intervention). In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 7. pp. 619-629.
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abstract = "Objectives This study sought to evaluate the clinical impact of intraprocedural stent thrombosis (IPST), a relatively new endpoint. Background In the prospective, double-blind, active-controlled CHAMPION PHOENIX (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial, cangrelor significantly reduced periprocedural and 30-day ischemic events in patients undergoing percutaneous coronary intervention (PCI), including IPST. Methods An independent core laboratory blinded to treatment assignment performed a frame-by-frame angiographic analysis in 10,939 patients for the development of IPST, defined as new or worsening thrombus related to stent deployment at any time during the procedure. Adverse events were adjudicated by an independent, blinded clinical events committee. Results IPST developed in 89 patients (0.8{\%}), including 35 of 5,470 (0.6{\%}) and 54 of 5,469 (1.0{\%}) patients in the cangrelor and clopidogrel arms, respectively (odds ratio: 0.65; 95{\%} confidence interval: 0.42 to 0.99; p = 0.04). Compared to patients without IPST, IPST was associated with a marked increase in composite ischemia (death, myocardial infarction [MI], ischemia-driven revascularization, or new-onset out-of-laboratory stent thrombosis [Academic Research Consortium]) at 48 h and at 30 days (29.2{\%} vs. 4.5{\%} and 31.5{\%} vs. 5.7{\%}, respectively; p < 0.0001 for both). After controlling for potential confounders, IPST remained a strong predictor of all adverse ischemic events at both time points. Conclusions In the large-scale CHAMPION PHOENIX trial, the occurrence of IPST was strongly predictive of subsequent adverse cardiovascular events. The potent intravenous adenosine diphosphate antagonist cangrelor substantially reduced IPST, contributing to its beneficial effects at 48 h and 30 days. (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX]; NCT01156571).",
author = "Philippe G{\'e}n{\'e}reux and Stone, {Gregg W.} and Harrington, {Robert A.} and Gibson, {C. Michael} and Steg, {Ph Gabriel} and Brener, {Sorin J.} and Angiolillo, {Dominick J.} and Price, {Matthew J.} and Jayne Prats and Laura Lasalle and Tiepu Liu and Meredith Todd and Simona Skerjanec and Hamm, {Christian W.} and Mahaffey, {Kenneth W.} and White, {Harvey D.} and Bhatt, {Deepak L.}",
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Impact of intraprocedural stent thrombosis during Percutaneous coronary intervention : Insights from the champion phoenix trial (clinical trial comparing Cangrelor to Clopidogrel standard of care therapy in subjects who require Percutaneous coronary intervention). / Généreux, Philippe; Stone, Gregg W.; Harrington, Robert A.; Gibson, C. Michael; Steg, Ph Gabriel; Brener, Sorin J.; Angiolillo, Dominick J.; Price, Matthew J.; Prats, Jayne; Lasalle, Laura; Liu, Tiepu; Todd, Meredith; Skerjanec, Simona; Hamm, Christian W.; Mahaffey, Kenneth W.; White, Harvey D.; Bhatt, Deepak L.

In: Journal of the American College of Cardiology, Vol. 63, No. 7, 25.02.2014, p. 619-629.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Impact of intraprocedural stent thrombosis during Percutaneous coronary intervention

T2 - Insights from the champion phoenix trial (clinical trial comparing Cangrelor to Clopidogrel standard of care therapy in subjects who require Percutaneous coronary intervention)

AU - Généreux, Philippe

AU - Stone, Gregg W.

AU - Harrington, Robert A.

AU - Gibson, C. Michael

AU - Steg, Ph Gabriel

AU - Brener, Sorin J.

AU - Angiolillo, Dominick J.

AU - Price, Matthew J.

AU - Prats, Jayne

AU - Lasalle, Laura

AU - Liu, Tiepu

AU - Todd, Meredith

AU - Skerjanec, Simona

AU - Hamm, Christian W.

AU - Mahaffey, Kenneth W.

AU - White, Harvey D.

AU - Bhatt, Deepak L.

PY - 2014/2/25

Y1 - 2014/2/25

N2 - Objectives This study sought to evaluate the clinical impact of intraprocedural stent thrombosis (IPST), a relatively new endpoint. Background In the prospective, double-blind, active-controlled CHAMPION PHOENIX (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial, cangrelor significantly reduced periprocedural and 30-day ischemic events in patients undergoing percutaneous coronary intervention (PCI), including IPST. Methods An independent core laboratory blinded to treatment assignment performed a frame-by-frame angiographic analysis in 10,939 patients for the development of IPST, defined as new or worsening thrombus related to stent deployment at any time during the procedure. Adverse events were adjudicated by an independent, blinded clinical events committee. Results IPST developed in 89 patients (0.8%), including 35 of 5,470 (0.6%) and 54 of 5,469 (1.0%) patients in the cangrelor and clopidogrel arms, respectively (odds ratio: 0.65; 95% confidence interval: 0.42 to 0.99; p = 0.04). Compared to patients without IPST, IPST was associated with a marked increase in composite ischemia (death, myocardial infarction [MI], ischemia-driven revascularization, or new-onset out-of-laboratory stent thrombosis [Academic Research Consortium]) at 48 h and at 30 days (29.2% vs. 4.5% and 31.5% vs. 5.7%, respectively; p < 0.0001 for both). After controlling for potential confounders, IPST remained a strong predictor of all adverse ischemic events at both time points. Conclusions In the large-scale CHAMPION PHOENIX trial, the occurrence of IPST was strongly predictive of subsequent adverse cardiovascular events. The potent intravenous adenosine diphosphate antagonist cangrelor substantially reduced IPST, contributing to its beneficial effects at 48 h and 30 days. (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX]; NCT01156571).

AB - Objectives This study sought to evaluate the clinical impact of intraprocedural stent thrombosis (IPST), a relatively new endpoint. Background In the prospective, double-blind, active-controlled CHAMPION PHOENIX (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial, cangrelor significantly reduced periprocedural and 30-day ischemic events in patients undergoing percutaneous coronary intervention (PCI), including IPST. Methods An independent core laboratory blinded to treatment assignment performed a frame-by-frame angiographic analysis in 10,939 patients for the development of IPST, defined as new or worsening thrombus related to stent deployment at any time during the procedure. Adverse events were adjudicated by an independent, blinded clinical events committee. Results IPST developed in 89 patients (0.8%), including 35 of 5,470 (0.6%) and 54 of 5,469 (1.0%) patients in the cangrelor and clopidogrel arms, respectively (odds ratio: 0.65; 95% confidence interval: 0.42 to 0.99; p = 0.04). Compared to patients without IPST, IPST was associated with a marked increase in composite ischemia (death, myocardial infarction [MI], ischemia-driven revascularization, or new-onset out-of-laboratory stent thrombosis [Academic Research Consortium]) at 48 h and at 30 days (29.2% vs. 4.5% and 31.5% vs. 5.7%, respectively; p < 0.0001 for both). After controlling for potential confounders, IPST remained a strong predictor of all adverse ischemic events at both time points. Conclusions In the large-scale CHAMPION PHOENIX trial, the occurrence of IPST was strongly predictive of subsequent adverse cardiovascular events. The potent intravenous adenosine diphosphate antagonist cangrelor substantially reduced IPST, contributing to its beneficial effects at 48 h and 30 days. (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX]; NCT01156571).

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