OBJECTIVES: The aim of this study was to assess the impact of early and late bleeding on subsequent mortality after drug-eluting stent (DES) implantation. BACKGROUND: Little is known about the impact of late bleeding after DES implantation. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
OBJECTIVES: The aim of this study was to assess the impact of early and late bleeding on subsequent mortality after drug-eluting stent (DES) implantation. BACKGROUND: Little is known about the impact of late bleeding after DES implantation. METHODS: 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. RESULTS: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. CONCLUSIONS: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.
Authors: Javier A Valle; Susan Shetterly; Thomas M Maddox; P Michael Ho; Steven M Bradley; Amneet Sandhu; David Magid; Thomas T Tsai Journal: Circ Cardiovasc Interv Date: 2016-06 Impact factor: 6.546