Carotid Stenosis Management During COVID-19 Era - Best Medical Intervention Alone (CASCOM Pilot Study): A Prospective Observational Study
Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS in time. This study aims to measure the rate of ipsilateral stroke and other complications in individuals with symptomatic carotid stenosis, whom for any reason are managed using current best medical intervention alone. The investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials.
• Patients who's life expectancy is \> 3 years despite age \> 80 years.
• Patients who have not been timely offered CEA under COVID-19 (eg women / men with 50-69%), which can only be operated on after 4 weeks after their last symptom.
• Patients with modified ranking scale (mRs) \> 3, which during rehabilitation improve and move to mRs \< 3.
• High risk cardio pulmonary patients (ejection fraction \< 20% - severe chronic obstructive pulmonary disease) that is not estimated to withstand surgery or has a technically demanding neck anatomy with a life expectancy \> 3 years.
• Patients who score below 15% on Carotid Artery Risk score (CAR-score) (5-year stroke risk is \< 15% with only best medical treatment) for ipsilateral stroke.
• Patients with newly discovered cancer and stroke who require a cancer disease investigation or treatment and have a life expectancy of more than 3 years.
• 50-69% and 70-99% narrowing (stenosis) of the ipsilateral internal carotid artery origin (and/or carotid bulb) verified by duplex ultrasound, CT-angio or MR-angio.
• Presence of an ipsilateral non-disabling (non-severe) stroke (mRs \< 3, ie mRs of 1 or 2) or transient ischaemic attack (TIA) in the previous four (1,2) to six months (1,3) and ipsilateral 50-99% carotid stenosis measured using NASCET criteria.
• Index symptoms attributable to atherosclerotic carotid disease (not due to fibromuscular dysplasia, aneurysm or tumour).
• Absence of severe stroke on either side resulting in no useful function in the affected arterial territory
• Absence of a known more severe ipsilateral intracranial infarct site of arterial narrowing
• Absence of previous ipsilateral CEA or angioplasty/stenting or other carotid revascularisation procedure.
• Mentally competent and consenting to participate in CASCOM Pilot Study in minimum 3 years.
• Life expectancy \> 3 years including the absence of kidney, liver or lung failure or advanced cancer or advanced dementia, major/severe stroke (mRs \> 3), perceived significant frailty or unsuitable arterial anatomy. Risk classification level of IV or higher as well as CAR-score.
• Absence of cardiac valvular or rhythm disorder likely associated with cardioembolism. In the absence of more specific published information the investigators will exclude patients with newly discovered atrial fibrillation and prosthetic heart valves from the primary analyses of symptomatic patients.