Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial.

OBJECTIVES: We aimed to investigate the long-term prognosis of patients with in-hospital major bleeding (IHMB).

BACKGROUND: The effect of IHMB on the long-term prognosis of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is unknown.

METHODS: Primary PCI was performed in 3,345 (92.9%) of 3,602 patients in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial; in-hospital protocol-defined non-coronary artery bypass graft-related major bleeding developed in 231 (6.9%). We examined medication use at discharge, mortality, and major adverse cardiovascular events (composite of death, reinfarction, stroke, or ischemic target vessel revascularization) at 3-year follow-up in patients with and without IHMB.

RESULTS: At 3-year follow-up, patients with IHMB had higher mortality (24.6% vs. 5.4%, p < 0.0001) and major adverse cardiovascular events (40.3% vs. 20.5%, p < 0.0001). The deleterious effect of major bleeding was observed within 1 month, between 1 month and 1 year, and between 1 and 3 years. IHMB was an independent predictor of mortality (hazard ratio: 2.80; 95% confidence interval: 1.89 to 4.16, p < 0.0001) at 3-year follow up.

CONCLUSIONS: Patients with IHMB after primary PCI have significantly increased 3-year rates of morbidity and mortality. Further investigation is warranted to understand the mechanisms underlying this relationship and to further improve outcomes in patients with ST-segment myocardial infarction. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).