The effect of cangrelor and access site on ischaemic and bleeding events

Insights from CHAMPION PHOENIX

J. Antonio Gutierrez, Robert A. Harrington, James C. Blankenship, Gregg W. Stone, Ph Gabriel Steg, C. Michael Gibson, Christian W. Hamm, Matthew J. Price, Philippe Genereux, Jayne Prats, Efthymios N. Deliargyris, Kenneth W. Mahaffey, Harvey D. White, Deepak L. Bhatt

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Aims To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y 12 inhibitor, in CHAMPION PHOENIX. Methods and results A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74%) and 2855 (26%) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8% with cangrelor vs. 6.0% with clopidogrel (odds ratio, OR [95% confidence interval, CI] = 0.79 [0.65-0.96]); among the radial cohort, the primary endpoint was 4.4% with cangrelor vs. 5.7% with clopidogrel (OR [95% CI] = 0.76 [0.54-1.06]), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.73 [0.51-5.93]). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.02 [0.14-7.28]), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2% with cangrelor vs. 3.1% with clopidogrel (OR [95% CI] = 1.69 [1.35-2.12]); among the radial cohort the rate of ACUITY major bleeding was 1.5% with cangrelor vs. 0.7% with clopidogrel (OR [95% CI] = 2.17 [1.02-4.62], P-interaction 0.54). Conclusion In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery.

Original languageEnglish (US)
Pages (from-to)1122-1130
Number of pages9
JournalEuropean Heart Journal
Volume37
Issue number14
DOIs
StatePublished - Apr 7 2016
Externally publishedYes

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clopidogrel
Hemorrhage
Percutaneous Coronary Intervention
Thigh
Confidence Intervals
Safety
cangrelor
Radial Artery
Stents
Myocardial Ischemia
Coronary Vessels
Thrombosis

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Gutierrez, J. A., Harrington, R. A., Blankenship, J. C., Stone, G. W., Steg, P. G., Gibson, C. M., ... Bhatt, D. L. (2016). The effect of cangrelor and access site on ischaemic and bleeding events: Insights from CHAMPION PHOENIX. European Heart Journal, 37(14), 1122-1130. https://doi.org/10.1093/eurheartj/ehv498
Gutierrez, J. Antonio ; Harrington, Robert A. ; Blankenship, James C. ; Stone, Gregg W. ; Steg, Ph Gabriel ; Gibson, C. Michael ; Hamm, Christian W. ; Price, Matthew J. ; Genereux, Philippe ; Prats, Jayne ; Deliargyris, Efthymios N. ; Mahaffey, Kenneth W. ; White, Harvey D. ; Bhatt, Deepak L. / The effect of cangrelor and access site on ischaemic and bleeding events : Insights from CHAMPION PHOENIX. In: European Heart Journal. 2016 ; Vol. 37, No. 14. pp. 1122-1130.
@article{b3c001d1f18f4eb5940dea0b466561ce,
title = "The effect of cangrelor and access site on ischaemic and bleeding events: Insights from CHAMPION PHOENIX",
abstract = "Aims To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y 12 inhibitor, in CHAMPION PHOENIX. Methods and results A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74{\%}) and 2855 (26{\%}) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8{\%} with cangrelor vs. 6.0{\%} with clopidogrel (odds ratio, OR [95{\%} confidence interval, CI] = 0.79 [0.65-0.96]); among the radial cohort, the primary endpoint was 4.4{\%} with cangrelor vs. 5.7{\%} with clopidogrel (OR [95{\%} CI] = 0.76 [0.54-1.06]), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2{\%} with cangrelor vs. 0.1{\%} with clopidogrel (OR [95{\%} CI] = 1.73 [0.51-5.93]). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1{\%} with cangrelor vs. 0.1{\%} with clopidogrel (OR [95{\%} CI] = 1.02 [0.14-7.28]), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2{\%} with cangrelor vs. 3.1{\%} with clopidogrel (OR [95{\%} CI] = 1.69 [1.35-2.12]); among the radial cohort the rate of ACUITY major bleeding was 1.5{\%} with cangrelor vs. 0.7{\%} with clopidogrel (OR [95{\%} CI] = 2.17 [1.02-4.62], P-interaction 0.54). Conclusion In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery.",
author = "Gutierrez, {J. Antonio} and Harrington, {Robert A.} and Blankenship, {James C.} and Stone, {Gregg W.} and Steg, {Ph Gabriel} and Gibson, {C. Michael} and Hamm, {Christian W.} and Price, {Matthew J.} and Philippe Genereux and Jayne Prats and Deliargyris, {Efthymios N.} and Mahaffey, {Kenneth W.} and White, {Harvey D.} and Bhatt, {Deepak L.}",
year = "2016",
month = "4",
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doi = "10.1093/eurheartj/ehv498",
language = "English (US)",
volume = "37",
pages = "1122--1130",
journal = "European Heart Journal",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "14",

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Gutierrez, JA, Harrington, RA, Blankenship, JC, Stone, GW, Steg, PG, Gibson, CM, Hamm, CW, Price, MJ, Genereux, P, Prats, J, Deliargyris, EN, Mahaffey, KW, White, HD & Bhatt, DL 2016, 'The effect of cangrelor and access site on ischaemic and bleeding events: Insights from CHAMPION PHOENIX', European Heart Journal, vol. 37, no. 14, pp. 1122-1130. https://doi.org/10.1093/eurheartj/ehv498

The effect of cangrelor and access site on ischaemic and bleeding events : Insights from CHAMPION PHOENIX. / Gutierrez, J. Antonio; Harrington, Robert A.; Blankenship, James C.; Stone, Gregg W.; Steg, Ph Gabriel; Gibson, C. Michael; Hamm, Christian W.; Price, Matthew J.; Genereux, Philippe; Prats, Jayne; Deliargyris, Efthymios N.; Mahaffey, Kenneth W.; White, Harvey D.; Bhatt, Deepak L.

In: European Heart Journal, Vol. 37, No. 14, 07.04.2016, p. 1122-1130.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The effect of cangrelor and access site on ischaemic and bleeding events

T2 - Insights from CHAMPION PHOENIX

AU - Gutierrez, J. Antonio

AU - Harrington, Robert A.

AU - Blankenship, James C.

AU - Stone, Gregg W.

AU - Steg, Ph Gabriel

AU - Gibson, C. Michael

AU - Hamm, Christian W.

AU - Price, Matthew J.

AU - Genereux, Philippe

AU - Prats, Jayne

AU - Deliargyris, Efthymios N.

AU - Mahaffey, Kenneth W.

AU - White, Harvey D.

AU - Bhatt, Deepak L.

PY - 2016/4/7

Y1 - 2016/4/7

N2 - Aims To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y 12 inhibitor, in CHAMPION PHOENIX. Methods and results A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74%) and 2855 (26%) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8% with cangrelor vs. 6.0% with clopidogrel (odds ratio, OR [95% confidence interval, CI] = 0.79 [0.65-0.96]); among the radial cohort, the primary endpoint was 4.4% with cangrelor vs. 5.7% with clopidogrel (OR [95% CI] = 0.76 [0.54-1.06]), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.73 [0.51-5.93]). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.02 [0.14-7.28]), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2% with cangrelor vs. 3.1% with clopidogrel (OR [95% CI] = 1.69 [1.35-2.12]); among the radial cohort the rate of ACUITY major bleeding was 1.5% with cangrelor vs. 0.7% with clopidogrel (OR [95% CI] = 2.17 [1.02-4.62], P-interaction 0.54). Conclusion In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery.

AB - Aims To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y 12 inhibitor, in CHAMPION PHOENIX. Methods and results A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74%) and 2855 (26%) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8% with cangrelor vs. 6.0% with clopidogrel (odds ratio, OR [95% confidence interval, CI] = 0.79 [0.65-0.96]); among the radial cohort, the primary endpoint was 4.4% with cangrelor vs. 5.7% with clopidogrel (OR [95% CI] = 0.76 [0.54-1.06]), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.73 [0.51-5.93]). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.02 [0.14-7.28]), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2% with cangrelor vs. 3.1% with clopidogrel (OR [95% CI] = 1.69 [1.35-2.12]); among the radial cohort the rate of ACUITY major bleeding was 1.5% with cangrelor vs. 0.7% with clopidogrel (OR [95% CI] = 2.17 [1.02-4.62], P-interaction 0.54). Conclusion In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery.

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Gutierrez JA, Harrington RA, Blankenship JC, Stone GW, Steg PG, Gibson CM et al. The effect of cangrelor and access site on ischaemic and bleeding events: Insights from CHAMPION PHOENIX. European Heart Journal. 2016 Apr 7;37(14):1122-1130. https://doi.org/10.1093/eurheartj/ehv498