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Triple Antithro..

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Dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine is recommended for all patients who undergo percutaneous coronary intervention (PCI) and receive stents.1-3 Both medications synergistically work to prevent stent thrombosis, but they also increase a patient’s risk of bleeding. Some patients however have indications requiring anticoagulation with a vitamin K antagonist (VKA) in addition to DAPT. This triple antithrombotic therapy can further increase the bleeding risk for a patient. The risks and benefits of triple antithrombotic therapy have not yet been fully studied. Using the data from the HORIZONS-AMI trial, Nikolsky and colleagues compared the outcomes of patients receiving triple therapy to patients receiving DAPT.4,5

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The HORIZONS-AMI trial enrolled 3,602 patients ≥18 years old who presented with a ST-elevation myocardial infarction (STEMI) within 12 hours of symptom onset.5 Patients were randomized to either receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor and then underwent coronary angiography with either emergent PCI, coronary artery bypass or medical management (determined by physician) after randomization. The study had numerous exclusion criteria which included previous administration of a fibrinolytic, bivalirudin, glycoprotein IIa/IIIb inhibitor, low-molecular weight heparin, or fondaparinux during the admission, current use of a VKA, history of bleeding diathesis, and conditions putting patients at increased risk of bleeding.5 DAPT was recommended for ≥1 year. Patients were started on VKAs during the index hospitalization or discharge at the discretion of the physician. The two primary endpoints for this trial were major bleeding unrelated to CABG and net adverse clinical events, which was defined as major bleeding, death, reinfarction, target vessel revascularization for ischemia, and stroke. Major bleeding was defined as intracranial or intraocular hemorrhage, access site bleeding requiring intervention, hematoma ≥5 cm in diameter, hemoglobin decrease ≥4 g/dL without or ≥3 g/dL with an over bleeding source, reoperation for bleeding, and blood transfusion.4 Comparisons for the primary endpoints between the DAPT and triple therapy groups were made after 30 days and after 1 year.5

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Of the patients enrolled in HORIZONS-AMI, the majority (n=3,345) underwent PCI and data regarding the use of aspirin, thienopyridine, and VKA was available in 3,320 patients. Only 126 patients (3.8%) were initiated on triple therapy during the index hospitalization or at discharge. The most common indications for VKA therapy included severely reduced left ventricular ejection fraction with a large akinetic region (23.8%), atrial fibrillation (23.8%), and mural thrombus in the left ventricle (23.0%). Patients receiving triple therapy were more likely to have a lower left ventricular ejection fraction, higher rates of left anterior descending artery infarcts, older age, female gender, history of rhythm disturbances, a greater incidence of Killip class >1 on admission, and lower rates of final TIMI flow grade 3. Patients receiving triple therapy experienced significantly more protocol-defined major bleeds than patients receiving only DAPT at both 30 days (15.1% vs. 7.1%, P=0.0008, numbers needed to harm, NNH, 13) and at 1 year (16.7% vs. 7.5%, P=0.0002, NNH 11). Significantly more protocol-defined minor ...

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