Little is known about the impact of late bleeding after DES implantation.
With a time-updated Cox model, the impact of bleeding and myocardial infarction (MI) on 3-year mortality was analyzed in 3,148 consecutive patients who underwent DES implantation for coronary disease.
Bleeding, defined according to STEEPLE (Safety and Efficacy of Enoxaparin in PCI Patients, an International Randomized Evaluation) minor or major criteria, occurred in 6.5 % of patients over 3 years. Patients with bleeding were older; were more likely to be female; had higher rates of diabetes mellitus, hypertension, and extensive coronary disease and lower ventricular function; and underwent more complex procedures than those without bleeding. The 3-year adjusted hazard ratios (HRs) for mortality were 5.81 (95 % confidence interval [CI]: 3.92 to 8.60; p < 0.001) for patients with bleeding and 2.53 (95 % CI: 1.62 to 3.96; p < 0.001) for patients with MI. When the timings of events were separated, the HRs for mortality were 4.89 (95 % CI: 3.08 to 7.78; p < 0.001) and 7.81 (95 % CI: 4.39 to 13.89; p < 0.001) for patients with bleeding within and after 30 days, respectively. By contrast, the HRs for mortality were 1.85 (95 % CI: 1.09 to 3.14, p = 0.022) and 10.33 (95 % CI: 4.91 to 21.75, p < 0.001) for patients with MI within and after 30 days, respectively.
Bleeding is closely associated with mortality during both the early and late periods after DES implantation. Therefore, in addition to carefully assessing bleeding after stenting, evidence-based treatment should be implemented to offer the best balance of benefit and harm.