Clinical Research
Interventional Cardiology
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

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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)

Key Words

bivalirudin
bleeding
clinical outcomes
prognosis

Abbreviations and Acronyms

CI
confidence interval
HR
hazard ratio
IHMB
in-hospital major bleeding
MACE
major adverse cardiac event(s)
MI
myocardial infarction
PCI
percutaneous coronary intervention
ST
stent thrombosis

Cited by (0)

The main study (HORIZON-AMI) of this post-hoc analysis was supported by the Cardiovascular Research Foundation with grant support from Boston Scientific and the Medicines Company. Dr. Mehran reported receiving lecture fees from Boston Scientific and the Medicines Company; is a consultant for Abbott Vascular, AstraZeneca, and Regado Biosciences; and has received research support from BMS/Sanofi-Aventis. Dr. Dangas has received an institutional research grant from The Medicines Co., Sanofi-Aventis, and Bristol-Myers Squibb; has received speaker honoraria from Cordis; and his spouse is on the advisory board for Abbott and AstraZeneca. Dr. Witzenbichler has received lecture fees from The Medicines Co. and Boston Scientific. Dr. Grines is on the advisory board for Abbott Vascular. Dr. Guagliumi has received consulting fees from or serving on advisory boards for Abbott Vascular and Boston Scientific; and has received grant support from Medtronic and Boston Scientific. Dr. Stone has received consulting fees from Medtronic, GlaxoSmithKline, Eli Lilly-Daiichi Sankyo, Merck, AstraZeneca, Boston Scientific, Abbott Vascular, The Medicines Co., and Bristol-Myers Squibb-Sanofi; and has received grant support from Boston Scientific, the Medicines Company, and Abbott Vascular. Dr. Dudek has received research grants or served as a consultant/advisory board member for Abbott, Adamed, AstraZeneca, Biotronik, Balton, Bayer, BBraun, BioMatrix, Boston Scientific, Boehringer Ingelheim, Bristol-Myers Squibb, Cordis, Cook Eli Lilly, EuroCor, Glaxo, Invatec, Medtronic, The Medicines Co., MSD, Nycomed, Orbus-Neich, Pfizer, Possis, Promed, Sanofi-Aventis, Siemens, Solvay, Terumo, and Tyco.

All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.