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

JACC Cardiovasc Interv. 2016 Jul 25;9(14):1450-7. doi: 10.1016/j.jcin.2016.04.037. Epub 2016 Jun 29.

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.

Keywords: bleeding; drug-eluting stent(s); ischemia; percutaneous coronary intervention; stent thrombosis.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aspirin / administration & dosage
  • Aspirin / adverse effects*
  • Chi-Square Distribution
  • Clopidogrel
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Thrombosis / diagnostic imaging
  • Coronary Thrombosis / etiology
  • Coronary Thrombosis / mortality*
  • Drug Therapy, Combination
  • Drug-Eluting Stents
  • Female
  • Germany
  • Hemorrhage / chemically induced
  • Hemorrhage / mortality*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Myocardial Infarction / diagnostic imaging
  • Myocardial Infarction / etiology
  • Myocardial Infarction / mortality*
  • Percutaneous Coronary Intervention / adverse effects*
  • Percutaneous Coronary Intervention / instrumentation
  • Percutaneous Coronary Intervention / mortality*
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / adverse effects*
  • Proportional Hazards Models
  • Prospective Studies
  • Registries
  • Risk Assessment
  • Risk Factors
  • Ticlopidine / administration & dosage
  • Ticlopidine / adverse effects
  • Ticlopidine / analogs & derivatives*
  • Time Factors
  • Treatment Outcome
  • United States

Substances

  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine
  • Aspirin