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

Objectives: We sought to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) on subsequent mortality.
Background: These events have been strongly associated with subsequent death.
Methods: In the multicenter, prospective ADAPT-DES study, patients at 11 clinical sites with successful PCI with DES had 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 (31-365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariable 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 had an event (12.4%): 691 had CB (8.1%), 294 had MI (3.4%), 75 had ST (0.9%), and 7,522 had no event (87.6%). The highest risk was associated with early ST (38.5% mortality at 30 days after the event), while very late MI (7.5%) and late CB (7.3%) were less dangerous. By multivariable 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 DES suffers 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.