Time-Dependent Associations Between Actionable Bleeding, Coronary Thrombotic Events, and Mortality Following Percutaneous Coronary Intervention: Results From the PARIS Registry

JACC Cardiovasc Interv. 2016 Jul 11;9(13):1349-57. doi: 10.1016/j.jcin.2016.04.009.

Abstract

Objectives: The aim of this study was to examine the independent associations between actionable bleeding (AB) and coronary thrombotic events (CTE) on mortality risk after percutaneous coronary intervention (PCI).

Background: The independent impact of AB and CTE on mortality risk after PCI remains poorly characterized.

Methods: A post hoc analysis was conducted of the PARIS (Patterns of Non-Adherence to Dual Antiplatelet Therapy in Stented Patients) registry, a real-world cohort of 5,018 patients undergoing PCI with stent implantation. CTE included definite or probable stent thrombosis or myocardial infarction. AB was defined as Bleeding Academic Research Consortium type 2 or 3. Associations between CTE and AB, both of which were modeled as time-dependent covariates, and 2-year mortality risk were examined using extended Cox regression.

Results: Over 2 years, the cumulative incidence of CTE, AB, and all-cause mortality was 5.9% (n = 289), 8.1% (n = 391), and 4.7% (n = 227), respectively. Adjusted hazard ratios for mortality associated with CTE and AB were 3.3 (95% confidence interval: 2.2 to 4.9) and 3.5 (95% confidence interval: 2.3 to 5.4), respectively. Temporal gradients in risk after either event were highest in the first 30 days and declined rapidly thereafter. Thrombotic events occurring while patients were on versus off dual-antiplatelet therapy were associated with a higher mortality risk, whereas risk related to AB was not influenced by dual-antiplatelet therapy status at the time of bleeding.

Conclusions: Intracoronary thrombosis and AB are associated with mortality risks of comparable magnitude over a 2-year period after PCI, findings that might inform risk/benefit calculations for extension versus discontinuation of dual-antiplatelet therapy.

Keywords: bleeding; dual-antiplatelet therapy; mortality.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Coronary Thrombosis / diagnostic imaging
  • Coronary Thrombosis / etiology
  • Coronary Thrombosis / mortality*
  • Drug Therapy, Combination
  • Europe
  • Female
  • Hemorrhage / diagnosis
  • Hemorrhage / etiology
  • Hemorrhage / mortality*
  • Humans
  • Incidence
  • Kaplan-Meier Estimate
  • Male
  • Medication Adherence
  • Middle Aged
  • 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
  • Stents
  • Time Factors
  • Treatment Outcome
  • United States

Substances

  • Platelet Aggregation Inhibitors