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Outcomes of Everolimus-Eluting Stents in Patients at High Bleeding Risk
Study Questions:
What are the long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) with a drug (everolimus)-eluting stent?
Methods:
Data on 10,502 patients were analyzed from four all-comers post-approval international registries. Patients with at least one of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease (CKD), anemia, or thrombocytopenia, and 3,507 (33%) were identified as HBR.
Results:
During 4-year follow-up, HBR patients had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (hazard ratio [HR], 4.38; 95% confidence interval [CI], 3.76- 5.11). Anemia, CKD, age ≥75 years, prior myocardial infarction (MI), and diabetes mellitus were the most significant predictors of all-cause death in HBR patients, whereas in non-HBR patients, they were current smoking, diabetes mellitus, and prior MI. Risk of mortality was increased after a chronic thrombotic event (HR, 5.02; 95% CI, 3.93-6.41), as well as after any major bleeding (HR, 4.92; 95% CI, 3.82-6.35) in the entire cohort irrespective of baseline bleeding risk. Compared to non-HBR, HBR patients were less likely to be on dual antiplatelet therapy (DAPT) (92.5% vs. 88.7% at 3 months, 84.8% vs. 78.0% at 1 year, and 45.2% vs. 39.6% at 4 years, respectively; all p < 0.01), but DAPT discontinuation was not associated with an increased risk of thrombotic events on follow-up.
Conclusions:
Compared to the non-HBR population, HBR patients experienced worse 4-year outcomes after PCI with the cobalt-chromium everolimus-eluting stent. Both coronary thrombotic events and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk.
Perspective:
Patients at high baseline bleeding risk have significantly more complex disease and experience very high post-PCI mortality on 4-year follow-up. Occurrence of major bleeding or ischemic event predispose all patients post-PCI to a higher subsequent mortality risk irrespective of DAPT duration. These results highlight the need for aggressive secondary prevention in such patients post-PCI. Further research targeting novel therapies such as PCSK9 inhibitors in this patient population will help identify other approaches to tackle this elevated long-term hazard in such patients.
Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Prevention, Anticoagulation Management and ACS, Interventions and ACS, Smoking
Keywords: Acute Coronary Syndrome, Anemia, Anticoagulants, Chromium, Cobalt, Diabetes Mellitus, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Polymers, Renal Insufficiency, Chronic, Secondary Prevention, Smoking, Stents, Stroke, Thrombocytopenia, Thrombosis
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