Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Study Overview
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Brief Summary
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Aim(s)/Objective(s) To evaluate the safety and efficacy of triple antithrombotic therapy in patients taking DAPT of aspirin and a P2Y12 inhibitor in addition to either a NOAC or warfarin for the prevention of thromboembolic or acute coronary syndrome (ACS) events in patients with non-valvular atrial fibrillation (AF), history of coronary artery disease (CAD)/stent placement or recurrent ACS event. To determine the Methodist Health System (MHS) prescribing practices and patterns in cardiac patients with a history of AF who are admitted for CAD or an ACS event requiring PCI. Hypothesis Primary Hypothesis Cardiac patients with a history of AF and an indication for long-term NOAC who are also prescribed DAPT following an ASC event or revascularization with stenting will demonstrate a significant difference in cardiovascular outcomes and major bleeding events when compared with warfarin-based triple therapy.

Detailed Description
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STUDY DESIGN Multi-center, retrospective cohort chart review study design Data will be collected on all triple therapy recipients who were discharged from a Methodist Health System (MHS) facility with prescriptions for a combination of aspirin, P2Y12 Inhibitor and an OAC of either a NOAC or warfarin between April 1, 2017 - April 1, 2018 Patient list will be generated in EPIC All data will be obtained from EPIC All data will be collected retrospectively after the patient is discharged from the hospital Data collection (planned completion date): May 2019 Study Inclusion Criteria: 18 years or older AF diagnosis ICD10 for ACS, STEMI or NSTEMI Discharged with triple therapy agents of aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), and OAC (warfarin, edoxaban, dabigatran, rivaroxaban, or apixaban) status post-stent Study Exclusion Criteria: Patients less than 18 years of age Prior intracranial bleeding prior to study start date GI hemorrhage within 1 month prior to study start date Major bleeding event with 1 month prior to study start date Hemorrhage disorder Stroke within 1 month prior to study start date Cardiogenic shock during admission at start date Contraindication to use of the study medications Peptic ulcer in the prior 6 months prior to study start date Thrombocytopenia (platelet concentration lower than 50×109/L) Thrombolysis In Myocardial Infarction (TIMI) major bleeding in the prior 12 months of study start date Pregnancy History of DVT or PE currently on OAC

Official Title
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Triple Antithrombotic Therapy in Cardiac Patients Requiring Revascularization

Conditions
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Cardiac Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 18 years or older AF diagnosis ICD10 for ACS, STEMI or NSTEMI Discharged with triple therapy agents of aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), and OAC (warfarin, edoxaban, dabigatran, rivaroxaban, or apixaban) status post-stent Exclusion Criteria: • Patients less than 18 years of age Prior intracranial bleeding prior to study start date GI hemorrhage within 1 month prior to study start date Major bleeding event with 1 month prior to study start date Hemorrhage disorder Stroke within 1 month prior to study start date Cardiogenic shock during admission at start date Contraindication to use of the study medications Peptic ulcer in the prior 6 months prior to study start date Thrombocytopenia (platelet concentration lower than 50×109/L) Thrombolysis In Myocardial Infarction (TIMI) major bleeding in the prior 12 months of study start date Pregnancy History of DVT or PE currently on OAC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| combination of aspirin, P2Y12 Inhibitor with a NOAC<br>As this is a retrospective study with limited patients available for the cohort, all patients meeting inclusion criteria from April 1, 2017 - April 1, 2018 will be included to obtain the largest sample size possible | |
| combination of aspirin, P2Y12 Inhibitor with warfarin<br>As this is a retrospective study with limited patients available for the cohort, all patients meeting inclusion criteria from April 1, 2017 - April 1, 2018 will be included to obtain the largest sample size possible | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between warfarin based triple therapy versus NOAC-based triple therapy in cardiac patients | To compare the incidence of MACE, stroke (ischemic and hemorrhage), MI (STEMI and NSTEMI), stent thrombosis, systemic embolism (VTE), death (all-cause, cardiac and non-cardiac) and CAD-associated hospitalizations/ED visits) in patients who received warfarin-based triple therapy versus NOAC-based triple therapy. | April 1, 2017 - April 1, 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD10 for ACS, STEMI or NSTEMI, Atrial Fibrillation