Short-and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: Insights from four validated bleeding scales in the CHAMPION trials

on behalf of the CHAMPION Investigators

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Aims: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). Methods and results: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). Conclusions: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

Original languageEnglish
Pages (from-to)e1841-e1849
JournalEuroIntervention
Volume13
Issue number15
DOIs
Publication statusPublished - Feb 1 2018

Fingerprint

Percutaneous Coronary Intervention
Hemorrhage
Mortality
Blood Transfusion
Clinical Trials

Keywords

  • Adjunctive pharmacotherapy
  • Bleeding
  • Death

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Short-and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention : Insights from four validated bleeding scales in the CHAMPION trials. / on behalf of the CHAMPION Investigators.

In: EuroIntervention, Vol. 13, No. 15, 01.02.2018, p. e1841-e1849.

Research output: Contribution to journalArticle

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abstract = "Aims: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). Methods and results: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5{\%} to >3.5{\%}). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). Conclusions: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.",
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author = "{on behalf of the CHAMPION Investigators} and Muthiah Vaduganathan and Harrington, {Robert A.} and Stone, {Gregg W.} and Steg, {Ph Gabriel} and Gibson, {C. Michael} and Hamm, {Christian W.} and Price, {Matthew J.} and Lopes, {Renato D.} and Sergio Leonardi and Deliargyris, {Efthymios N.} and Jayne Prats and Mahaffey, {Kenneth W.} and White, {Harvey D.} and Bhatt, {Deepak L.}",
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T1 - Short-and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention

T2 - Insights from four validated bleeding scales in the CHAMPION trials

AU - on behalf of the CHAMPION Investigators

AU - Vaduganathan, Muthiah

AU - Harrington, Robert A.

AU - Stone, Gregg W.

AU - Steg, Ph Gabriel

AU - Gibson, C. Michael

AU - Hamm, Christian W.

AU - Price, Matthew J.

AU - Lopes, Renato D.

AU - Leonardi, Sergio

AU - Deliargyris, Efthymios N.

AU - Prats, Jayne

AU - Mahaffey, Kenneth W.

AU - White, Harvey D.

AU - Bhatt, Deepak L.

PY - 2018/2/1

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N2 - Aims: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). Methods and results: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). Conclusions: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

AB - Aims: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). Methods and results: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). Conclusions: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

KW - Adjunctive pharmacotherapy

KW - Bleeding

KW - Death

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