Full CASCOM Study Summary

Background

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.


CASCOM Study Aim/Objectives

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).


Methods

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.


Expected Findings and Significance

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.


Contact Information for the CASCOM Study

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:

Denmark

Emilie Nøddeskov Eilersen, MD; SC, Roskilde

Saeid H. Shahidi, MD; CI, Roskilde

Martin Lawaetz, MD; SC, Roskilde

Australia

Anne Abbott, PhD, MBBS, FRACP; CI, Melbourne

Tissa Wijeratne, MBBS MD FRACP FRCP(Edin) FRCP(London) FAAN; CI, Melbourne

Italy

Luca Saba, MD; CI, Cagliari

Pier Luigi Antignani, MD, PhD, FIUA; CI, Rome

United Kingdom

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

Ireland

Sherif Sultan, MD FRCS FACS PhD; CI, Galway

Greece

Christos Liapis, MD, PhD, FACS, FRCS Eng, FEBVS; CI Athens

Efthymios “Makis” Avgerinos, MD, FACS, FEBVS; CI Athens

United States of America

Hannah Gardener, ScD: CI, Miami

France

Claude Vaislic, MD, FEBTCVS; CI, Le chesnay

Poland

Grzegorz Madycki, M.D., Ph.D, FSPVS; CI, Warsaw

Piotr Myrcha, MD, PhD, FSVS; CI, Warsaw

Saudi Arabia

Omar Ayoub MBBS, FRCPC, CI, Jeddah

Croatia

Hrvoje Budincevic, MD PhD, FEAN, FESO; CI, Zagreb

Copyright 2020 FACTCATS