Epidemiology of bleeding complications post-Acute Coronary Syndrome within the UK primary care setting

Study type
Protocol
Date of Approval
Study reference ID
17_181
Lay Summary

Antithrombotic drugs are medications that are given to someone who has had a heart attack in order to prevent them from further heart attacks. These antithrombotic drugs while preventing further heart attack also cause bleeding. This bleeding can occur while the patient is still in the hospital or late after hospital discharge. Evidence has shown that the rate of bleeds that occur in the hospital setting is between 1% and 10%, and these in-hospital bleeds may cause death. However, the rate of bleeds that occur in the longer term after the patient has been discharge from hospital and whether these bleeds also cause death is not known. This study will determine the rate of these longer term bleeds that occur after hospital discharge and the characteristics of patients likely to develop these bleeds using routinely collected health information from the Clinical Practice Research Datalink. The study will also examine whether patients who sustained these longer term bleeds are more likely to die than those who did not. The finding from this study will help improve how patients are treated after discharge from hospital for heart attack.

Technical Summary

Objectives: To determine the rate of bleeding post hospital discharge, the characteristics of patients likely to develop these bleeding complications and whether these bleeds increase the rate of death. Methods: Using a retrospective cohort design, we will study patients 18 years and over with a new diagnosis of heart attack and no prior record of heart attack in the preceding 2 years within CPRD and follow them for bleeding consultation records. Follow-up will start from date of hospital discharge until the date they no longer contribute to CPRD due to death or leaving practice or practice leaving CPRD or end of 2016. We will compare the rate of death among those with bleeding consultation post hospital discharge and those without. Data analysis: First the rate of bleeding post hospital discharge will be determined per 1000 person years at risk. Second, associations between bleeding post hospital discharge with socio-demographic characteristics, baseline clinical characteristics, in-hospital intervention and discharge medication will be investigated to determine the risk factors of bleeding. Finally, association between bleeding post-hospital discharge and death from all cause will be investigated, adjusting for risk factors identified in stage 2 above using Cox proportional hazard regression.

Health Outcomes to be Measured

Bleeding complications; All-cause mortality.

Collaborators

Mamas Mamas - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
John Edwards - Collaborator - Keele University
Muhammad Rashid - Collaborator - Keele University
Nafiu Ismail - Collaborator - Keele University
Umesh Kadam - Collaborator - University of Leicester

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation