Carotid artery procedures (such as endarterectomy and stenting) are often performed even when patient benefit has not been established in past randomised trials.
Furthermore, there is no current evidence of procedural benefit compared to current optimal medical intervention alone for any person with carotid stenosis.
Medical intervention refers to lifestyle coaching and appropriate medication with respect to arterial disease risk factors, such as high blood pressure, blood cholesterol levels, physical inactivity, atrial fibrillation and tobacco smoking.
Medical intervention for stroke prevention is highly effective and continues to improve. The stroke prevention efficacy of current best medical intervention has not been measured.
In some places, the COVID-19 pandemic has made it difficult or impossible to perform carotid artery procedures. The pandemic has provided impetus to the CASCOM Study.
1. To measure the rate of stroke, and other arterial disease complications, in people with advanced (50-99%) carotid stenosis (arterial disease narrowing) who, for any reason, are managed with only current best medical intervention.
Reasons for a non-procedural approach may include procedural unavailability due to the coronavirus pandemic, unproven procedural benefit, anticipated procedural futility and/or net harm, or patient refusal.
CASCOM is a study for patients for whom carotid procedures are not possible or considered unethical. Therefore, recruiting these patients to randomised trials involving carotid procedures is considered inappropriate.
2. To compare the CASCOM Study rate of same-sided stroke for symptomatic patients with that reported in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST), and the CASCOM Study rate of same-sided stroke associated with asymptomatic carotid stenosis with that reported in the Asymptomatic Carotid Atherosclerosis Study (ACAS).
CASCOM is a prospective cohort study of current best medical intervention alone for stroke prevention. It is also a multi-national, multi-specialty, collaborative, quality assurance and evaluation project being conducted under the auspices of the International Union of Angiology.
We will separate patients into those who would, and would not, have been eligible for past randomised trials of carotid endarterectomy versus medical intervention alone.
We plan to study >250 symptomatic patients and >530 asymptomatic patients using ‘REDCap’ (Research Electronic Data Capture) for case reporting.
In CASCOM we expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials.
If correct, CASCOM will provide new evidence that past randomised trials of carotid endarterectomy and stenting are outdated and elucidate improved standards for preventing stroke and other arterial disease complications.
New CASCOM investigators and participants are welcome. If interested, please contact any of the CASCOM Chief Investigators (CI) or study coordinators (SC) as listed below:
Emilie Nøddeskov Eilersen, MD; SC, Roskilde
Saeid H. Shahidi, MD; CI, Roskilde
Martin Lawaetz, MD; SC, Roskilde
Anne Abbott, PhD, MBBS, FRACP; CI, Melbourne
Tissa Wijeratne, MBBS MD FRACP FRCP(Edin) FRCP(London) FAAN; CI, Melbourne
Luca Saba, MD; CI, Cagliari
Pier Luigi Antignani, MD, PhD, FIUA; CI, Rome
Alun Davies, MA, DM, FRCS, DSc, FHEA, FEBVS, FACPh, FLSW; CI, London
Ankur Thapar, PhD, FCRCS (Gen Surg), FHEA, PGCertMedEd; CI, London
Gregory Lip, MD FRCP; CI, Liverpool
Sherif Sultan, MD FRCS FACS PhD; CI, Galway
Christos Liapis, MD, PhD, FACS, FRCS Eng, FEBVS; CI Athens
Efthymios “Makis” Avgerinos, MD, FACS, FEBVS; CI Athens
Hannah Gardener, ScD: CI, Miami
Claude Vaislic, MD, FEBTCVS; CI, Le chesnay
Grzegorz Madycki, M.D., Ph.D, FSPVS; CI, Warsaw
Piotr Myrcha, MD, PhD, FSVS; CI, Warsaw
Omar Ayoub MBBS, FRCPC, CI, Jeddah
Hrvoje Budincevic, MD PhD, FEAN, FESO; CI, Zagreb