The Effect of Pre- and Post-Operative Blood Pressure Control on the Incidence of Type II Endoleak after Endovascular Aneurysm Repair (BOLD Trial)

RCT conducted with two groups, an INTERVENTIONAL group and a CONTROL group. Recruitment to either group is randomized and strictly occurs after the patient has been booked for elective endovascular aneurysm repair (EVAR) for a threshold infrarenal abdominal aortic aneurysm. Both groups will have their co-morbidities and pre-trial medications recorded. Both groups will be subject to twice-daily blood-pressure monitoring in the community for 3-weeks prior and 6-weeks post-operatively. Participants will be given a standardised and calibrated blood-pressure machine and will be instructed on its use. They will be asked to self-administer the blood-pressure machine and record the results. Results will then be uploaded by the patient onto a secure Google Forms website OR scanned and e-mailed to a secure Project e-mail OR given via phone to the study investigators on a, at a minimum, weekly basis. To corroborate the results, the machines also have 2-month memory which the investigators will interrogate at the end of the study period. The INTERVENTIONAL group will have weekly appointments, either via Telehealth/phone-call OR in-person (per patient preference) to review their weekly blood-pressure measurements. In this group, the investigators will intend to target a systolic blood-pressure of <120mmHg. At this weekly appointment, if the median blood-pressure is >120mmHg, the investigators are forced to make an adjustment to the current anti-hypertensive regime to intend to meet the systolic target. For safety, we have not clarified a specific anti-hypertensive regime, though will make it clear that the investigators must follow best medical practice. We intend to follow the hierarchical strategy for non-urgent hypertension modification in the independent, non-profit, Queensland-Health endorsed eTG by the Therapeutic Guidelines (TGL) group. Medication decisions will be supervised by a consultant Physician and a senior pharmacist. At this change, the patient's will be given a new prescription for either an increased dose or an additional anti-hypertensive agent. We intend to cover the cost of scripts and ideally, provide access to these prescriptions via the Hospital Pharmacy at the same appointment to ensure adherence. Further, we intend to monitor fidelity to the new regime at these weekly appointments. The CONTROL group similarly has weekly appointments to ensure BP monitoring is being completed and that the participants are entering the data correctly. In this arm, we will not target to a specific blood-pressure.