Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI

Gennaro Giustino, Roxana Mehran, George D. Dangas, Ajay J. Kirtane, Björn Redfors, Philippe Genereux, Sorin J. Brener, Jayne Prats, Stuart J. Pocock, Efthymios N. Deliargyris, Gregg W. Stone

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals. Objectives This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI. Methods Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non–coronary artery bypass graft–related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs. Results The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11%; 95% confidence interval [CI]: −0.35% to 0.58%; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: −0.39%; 95% CI: −0.58% to −0.20%; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51%; 95% CI: 1.04% to 1.98%; p < 0.0001). Conclusions After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.

Original languageEnglish (US)
Pages (from-to)1846-1857
Number of pages12
JournalJournal of the American College of Cardiology
Volume70
Issue number15
DOIs
StatePublished - Oct 10 2017

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Percutaneous Coronary Intervention
Myocardial Infarction
Hemorrhage
Least-Squares Analysis
clopidogrel
Confidence Intervals
Stents
Ischemia
Poisson Distribution
Aspirin
Thrombosis
Blood Platelets
Arteries
Odds Ratio

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Giustino, Gennaro ; Mehran, Roxana ; Dangas, George D. ; Kirtane, Ajay J. ; Redfors, Björn ; Genereux, Philippe ; Brener, Sorin J. ; Prats, Jayne ; Pocock, Stuart J. ; Deliargyris, Efthymios N. ; Stone, Gregg W. / Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI. In: Journal of the American College of Cardiology. 2017 ; Vol. 70, No. 15. pp. 1846-1857.
@article{f7f117d0a733458691f4785909124609,
title = "Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI",
abstract = "Background The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals. Objectives This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI. Methods Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non–coronary artery bypass graft–related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs. Results The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11{\%}; 95{\%} confidence interval [CI]: −0.35{\%} to 0.58{\%}; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: −0.39{\%}; 95{\%} CI: −0.58{\%} to −0.20{\%}; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51{\%}; 95{\%} CI: 1.04{\%} to 1.98{\%}; p < 0.0001). Conclusions After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.",
author = "Gennaro Giustino and Roxana Mehran and Dangas, {George D.} and Kirtane, {Ajay J.} and Bj{\"o}rn Redfors and Philippe Genereux and Brener, {Sorin J.} and Jayne Prats and Pocock, {Stuart J.} and Deliargyris, {Efthymios N.} and Stone, {Gregg W.}",
year = "2017",
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language = "English (US)",
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pages = "1846--1857",
journal = "Journal of the American College of Cardiology",
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Giustino, G, Mehran, R, Dangas, GD, Kirtane, AJ, Redfors, B, Genereux, P, Brener, SJ, Prats, J, Pocock, SJ, Deliargyris, EN & Stone, GW 2017, 'Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI', Journal of the American College of Cardiology, vol. 70, no. 15, pp. 1846-1857. https://doi.org/10.1016/j.jacc.2017.08.018

Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI. / Giustino, Gennaro; Mehran, Roxana; Dangas, George D.; Kirtane, Ajay J.; Redfors, Björn; Genereux, Philippe; Brener, Sorin J.; Prats, Jayne; Pocock, Stuart J.; Deliargyris, Efthymios N.; Stone, Gregg W.

In: Journal of the American College of Cardiology, Vol. 70, No. 15, 10.10.2017, p. 1846-1857.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Characterization of the Average Daily Ischemic and Bleeding Risk After Primary PCI for STEMI

AU - Giustino, Gennaro

AU - Mehran, Roxana

AU - Dangas, George D.

AU - Kirtane, Ajay J.

AU - Redfors, Björn

AU - Genereux, Philippe

AU - Brener, Sorin J.

AU - Prats, Jayne

AU - Pocock, Stuart J.

AU - Deliargyris, Efthymios N.

AU - Stone, Gregg W.

PY - 2017/10/10

Y1 - 2017/10/10

N2 - Background The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals. Objectives This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI. Methods Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non–coronary artery bypass graft–related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs. Results The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11%; 95% confidence interval [CI]: −0.35% to 0.58%; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: −0.39%; 95% CI: −0.58% to −0.20%; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51%; 95% CI: 1.04% to 1.98%; p < 0.0001). Conclusions After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.

AB - Background The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals. Objectives This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI. Methods Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non–coronary artery bypass graft–related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs. Results The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11%; 95% confidence interval [CI]: −0.35% to 0.58%; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: −0.39%; 95% CI: −0.58% to −0.20%; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51%; 95% CI: 1.04% to 1.98%; p < 0.0001). Conclusions After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.

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