[Skip to Content]
[Skip to Content Landing]
Views 3,513
Citations 0
Original Investigation
March 15, 2017

Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary StentingA Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study

Author Affiliations
  • 1Division of Cardiology, Massachusetts General Hospital, Boston
  • 2Harvard Medical School, Boston, Massachusetts
  • 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
  • 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
  • 5Baim Institute for Clinical Research, Boston, Massachusetts
  • 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
  • 7Christ Hospital Heart and Vascular Center, Cincinnati, Ohio
  • 8Lindner Center for Research and Education, Cincinnati, Ohio
  • 9Saint Luke’s Mid America Heart Institute, Kansas City, Missouri
  • 10University of Missouri–Kansas City School of Medicine, Kansas City, Missouri
  • 11Université Paris-Diderot, Institut National de la Santé et de la Récherche Médicale U-1148, Hôpital Bichat, Paris, France
  • 12Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique, Hôpitaux de Paris, Paris, France
  • 13National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, England
  • 14Division of Cardiology, Brigham and Women’s Hospital, Boston, Massachusetts
  • 15Boston University School of Public Health, Boston, Massachusetts
JAMA Cardiol. Published online March 15, 2017. doi:10.1001/jamacardio.2017.0063
Key Points

Question  What is the prognosis of ischemic and bleeding events occurring beyond 1 year after coronary stenting?

Findings  Among 11 648 individuals who underwent randomization in the Dual Antiplatelet Therapy (DAPT) Study, ischemic events occurred in 4%, 11% died, and the cumulative incidence of death after an ischemic event was 0.5%. Bleeding events occurred in 2%, 18% died, and the cumulative incidence of death after a bleeding event was 0.3%.

Meaning  Among patients surviving 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality.

Abstract

Importance  Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality.

Objective  To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting.

Design, Setting, and Participants  This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multicenter trial involving 220 US and international clinical sites from 11 countries. The study dates were August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015.

Exposures  Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding).

Main Outcomes and Measures  Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting).

Results  In total, 25 682 individuals older than 18 years with an indication for coronary stenting were enrolled, and 11 648 (mean age, 61.3 years; 25.1% female) were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52 (10.9%) died. The annualized mortality rate after an ischemic event was 27.2 (95% CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5% (0.3% with myocardial infarction, 0.1% with stent thrombosis, and 0.1% with ischemic stroke). Among individuals with bleeding events, 41 (17.7%) died. The annualized mortality rate after a bleeding event was 21.5 (95% CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3% (0.1% with moderate and 0.2% with severe bleeding).

Conclusions and Relevance  In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality.

Trial Registration  clinicaltrials.gov Identifier: NCT00977938

×