The Impact of Timing of Ischemic and Hemorrhagic Events on Mortality After Percutaneous Coronary Intervention: The ADAPT-DES Study

Sorin J. Brener, Ajay J. Kirtane, Thomas D. Stuckey, Bernhard Witzenbichler, Michael J. Rinaldi, Franz Josef Neumann, D. Christopher Metzger, Timothy D. Henry, David A. Cox, Peter L. Duffy, Ernest L. Mazzaferri, Roxana Mehran, Rupa Parvataneni, Bruce R. Brodie, Gregg W. Stone

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Objectives The aim of this study was to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents on subsequent mortality. Background These events have been strongly associated with subsequent death. Methods In the multicenter, prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents) study, patients at 11 clinical sites with successful PCI with drug-eluting stents underwent assessment of platelet function and were followed for 2 years. Events occurring after PCI—definite or probable stent thrombosis (ST), myocardial infarction (MI) not related to ST, and clinically relevant bleeding (CB)—were classified as early (≤30 days), late (31 to 365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariate modeling was used to analyze the relationship between each event (as a time-updated variable) and mortality over the entire study period. Results Among 8,582 patients, 1,060 (12.4%) had events—691 (8.1%) had CB, 294 (3.4%) had MI, and 75 (0.9%) had ST—and 7,522 (87.6%) had no events. The highest risk was associated with early ST (38.5% mortality at 30 days after the event), whereas very late MI (7.5%) and late CB (7.3%) were less dangerous. By multivariate analysis, each event was independently predictive of death, with hazard ratios of 2.4, 1.8, and 11.4, respectively (p < 0.0001). Conclusions Approximately 1 in 8 patients successfully undergoing PCI with drug-eluting stents had CB, MI, or ST during the ensuing 2 years. These events are associated with an increased hazard of mortality, particularly within the first 30 days following the event, warranting efforts to prevent their occurrence.

Original languageEnglish (US)
Pages (from-to)1450-1457
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume9
Issue number14
DOIs
StatePublished - Jul 1 2016

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Drug-Eluting Stents
Percutaneous Coronary Intervention
Stents
Thrombosis
Myocardial Infarction
Mortality
Hemorrhage
Therapeutics
Blood Platelets
Multivariate Analysis

Keywords

  • bleeding
  • drug-eluting stent(s)
  • ischemia
  • percutaneous coronary intervention
  • stent thrombosis

Cite this

Brener, S. J., Kirtane, A. J., Stuckey, T. D., Witzenbichler, B., Rinaldi, M. J., Neumann, F. J., ... Stone, G. W. (2016). The Impact of Timing of Ischemic and Hemorrhagic Events on Mortality After Percutaneous Coronary Intervention: The ADAPT-DES Study. JACC: Cardiovascular Interventions, 9(14), 1450-1457. https://doi.org/10.1016/j.jcin.2016.04.037

The Impact of Timing of Ischemic and Hemorrhagic Events on Mortality After Percutaneous Coronary Intervention : The ADAPT-DES Study. / Brener, Sorin J.; Kirtane, Ajay J.; Stuckey, Thomas D.; Witzenbichler, Bernhard; Rinaldi, Michael J.; Neumann, Franz Josef; Metzger, D. Christopher; Henry, Timothy D.; Cox, David A.; Duffy, Peter L.; Mazzaferri, Ernest L.; Mehran, Roxana; Parvataneni, Rupa; Brodie, Bruce R.; Stone, Gregg W.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 14, 01.07.2016, p. 1450-1457.

Research output: Contribution to journalArticle

Brener, SJ, Kirtane, AJ, Stuckey, TD, Witzenbichler, B, Rinaldi, MJ, Neumann, FJ, Metzger, DC, Henry, TD, Cox, DA, Duffy, PL, Mazzaferri, EL, Mehran, R, Parvataneni, R, Brodie, BR & Stone, GW 2016, 'The Impact of Timing of Ischemic and Hemorrhagic Events on Mortality After Percutaneous Coronary Intervention: The ADAPT-DES Study', JACC: Cardiovascular Interventions, vol. 9, no. 14, pp. 1450-1457. https://doi.org/10.1016/j.jcin.2016.04.037
Brener, Sorin J. ; Kirtane, Ajay J. ; Stuckey, Thomas D. ; Witzenbichler, Bernhard ; Rinaldi, Michael J. ; Neumann, Franz Josef ; Metzger, D. Christopher ; Henry, Timothy D. ; Cox, David A. ; Duffy, Peter L. ; Mazzaferri, Ernest L. ; Mehran, Roxana ; Parvataneni, Rupa ; Brodie, Bruce R. ; Stone, Gregg W. / The Impact of Timing of Ischemic and Hemorrhagic Events on Mortality After Percutaneous Coronary Intervention : The ADAPT-DES Study. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 14. pp. 1450-1457.
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abstract = "Objectives The aim of this study was to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents on subsequent mortality. Background These events have been strongly associated with subsequent death. Methods In the multicenter, prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents) study, patients at 11 clinical sites with successful PCI with drug-eluting stents underwent assessment of platelet function and were followed for 2 years. Events occurring after PCI—definite or probable stent thrombosis (ST), myocardial infarction (MI) not related to ST, and clinically relevant bleeding (CB)—were classified as early (≤30 days), late (31 to 365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariate modeling was used to analyze the relationship between each event (as a time-updated variable) and mortality over the entire study period. Results Among 8,582 patients, 1,060 (12.4{\%}) had events—691 (8.1{\%}) had CB, 294 (3.4{\%}) had MI, and 75 (0.9{\%}) had ST—and 7,522 (87.6{\%}) had no events. The highest risk was associated with early ST (38.5{\%} mortality at 30 days after the event), whereas very late MI (7.5{\%}) and late CB (7.3{\%}) were less dangerous. By multivariate analysis, each event was independently predictive of death, with hazard ratios of 2.4, 1.8, and 11.4, respectively (p < 0.0001). Conclusions Approximately 1 in 8 patients successfully undergoing PCI with drug-eluting stents had CB, MI, or ST during the ensuing 2 years. These events are associated with an increased hazard of mortality, particularly within the first 30 days following the event, warranting efforts to prevent their occurrence.",
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T2 - The ADAPT-DES Study

AU - Brener, Sorin J.

AU - Kirtane, Ajay J.

AU - Stuckey, Thomas D.

AU - Witzenbichler, Bernhard

AU - Rinaldi, Michael J.

AU - Neumann, Franz Josef

AU - Metzger, D. Christopher

AU - Henry, Timothy D.

AU - Cox, David A.

AU - Duffy, Peter L.

AU - Mazzaferri, Ernest L.

AU - Mehran, Roxana

AU - Parvataneni, Rupa

AU - Brodie, Bruce R.

AU - Stone, Gregg W.

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N2 - Objectives The aim of this study was to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents on subsequent mortality. Background These events have been strongly associated with subsequent death. Methods In the multicenter, prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents) study, patients at 11 clinical sites with successful PCI with drug-eluting stents underwent assessment of platelet function and were followed for 2 years. Events occurring after PCI—definite or probable stent thrombosis (ST), myocardial infarction (MI) not related to ST, and clinically relevant bleeding (CB)—were classified as early (≤30 days), late (31 to 365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariate modeling was used to analyze the relationship between each event (as a time-updated variable) and mortality over the entire study period. Results Among 8,582 patients, 1,060 (12.4%) had events—691 (8.1%) had CB, 294 (3.4%) had MI, and 75 (0.9%) had ST—and 7,522 (87.6%) had no events. The highest risk was associated with early ST (38.5% mortality at 30 days after the event), whereas very late MI (7.5%) and late CB (7.3%) were less dangerous. By multivariate analysis, each event was independently predictive of death, with hazard ratios of 2.4, 1.8, and 11.4, respectively (p < 0.0001). Conclusions Approximately 1 in 8 patients successfully undergoing PCI with drug-eluting stents had CB, MI, or ST during the ensuing 2 years. These events are associated with an increased hazard of mortality, particularly within the first 30 days following the event, warranting efforts to prevent their occurrence.

AB - Objectives The aim of this study was to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents on subsequent mortality. Background These events have been strongly associated with subsequent death. Methods In the multicenter, prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents) study, patients at 11 clinical sites with successful PCI with drug-eluting stents underwent assessment of platelet function and were followed for 2 years. Events occurring after PCI—definite or probable stent thrombosis (ST), myocardial infarction (MI) not related to ST, and clinically relevant bleeding (CB)—were classified as early (≤30 days), late (31 to 365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariate modeling was used to analyze the relationship between each event (as a time-updated variable) and mortality over the entire study period. Results Among 8,582 patients, 1,060 (12.4%) had events—691 (8.1%) had CB, 294 (3.4%) had MI, and 75 (0.9%) had ST—and 7,522 (87.6%) had no events. The highest risk was associated with early ST (38.5% mortality at 30 days after the event), whereas very late MI (7.5%) and late CB (7.3%) were less dangerous. By multivariate analysis, each event was independently predictive of death, with hazard ratios of 2.4, 1.8, and 11.4, respectively (p < 0.0001). Conclusions Approximately 1 in 8 patients successfully undergoing PCI with drug-eluting stents had CB, MI, or ST during the ensuing 2 years. These events are associated with an increased hazard of mortality, particularly within the first 30 days following the event, warranting efforts to prevent their occurrence.

KW - bleeding

KW - drug-eluting stent(s)

KW - ischemia

KW - percutaneous coronary intervention

KW - stent thrombosis

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