The European Carotid Surgery Trial 2 (ECST-2)

PATIENTS PRESENTING WITH TIAs

Do two TIAs one month apart constitute multiple TIAs or single TIAs for the screening form?
Multiple
What is the length of time between TIAs for it to be classified multiple or single?
More than one in the last 6 months should be classified as multiple.
Is a stroke or TIA with an undetermined cause symptomatic or asymptomatic?
Symptomatic, so long as the symptoms originated in the carotid territory of the brain in the side of the stenosis and occurred within the last 180 days. A stenosis with symptoms that occurred more than 180 days ago is classified as asymptomatic.

QUESTIONS ABOUT SCREENING PATIENTS
Asymptomatic vs Symptomatic Patients

Can I use the CAR score app to screen a patient with asymptomatic stenosis?
No, the CAR score app can currently only be used to screen symptomatic stenosis. However, asymptomatic stenosis will always have a low CAR score and is therefore automatically eligible for ECST-2.Is it the stenosis or the patient who is symptomatic?
From the point of view of ECST-2, it is the carotid stenosis that is symptomatic or asymptomatic. To count as symptomatic stenosis, the patient must have had relevant carotid territory symptoms in the past 180 days in the hemisphere on the side of the carotid stenosis (ipsilateral stenosis). If the stenosis is on the side of the hemisphere opposite to the hemisphere that has given rise to symptoms (contralateral stenosis), then the stenosis is asymptomatic. If the symptoms came on more than 180 days prior to randomisation, then the stenosis is counted as asymptomatic.
Don’t forget that a patient with hemiparesis secondary to carotid stenosis will have the weakness on the side of the body opposite to the stenosis e.g. a left middle cerebral infarct secondary to left carotid stenosis will cause weakness on the patient’s right hand side.
Can a centre join the trial and choose to randomise only symptomatic or only asymptomatic patients as a policy?
Yes, if the investigators only have equipoise concerning the one group of patients. However, the reason ECST-2 is recruiting both symptomatic and asymptomatic stenosis is that previous trial evidence suggests that low risk symptomatic patients treated with OMT have a similar risk of recurrent events to an asymptomatic patient. The trial uses the CAR score to select the lower risk symptomatic patients. Asymptomatic stenosis is automatically eligible so long as there are no other reasons for exclusion.
What about a patient with bilateral stenosis?
A patient can only be randomised once in ECST-2 and therefore you need to choose which stenosis is the most important and randomise the patient for that stenosis.
 In the case of a patient who has both symptomatic and asymptomatic stenosis, choose the symptomatic stenosis and perform the CAR score screening for that stenosis only. If the CAR score indicates that the stenosis is suitable for ECST, you should choose that stenosis as the randomised side. The randomisation website asks ‘which artery is to be treated first’ in case both arteries are planned for revascularisation in the trial, but in this patient you should give the symptomatic side as the artery to be treated first.
 If the CAR score indicates that the patient should be referred for revascularisation, the patient can still be randomised choosing the contralateral asymptomatic stenosis as the randomised side, but randomisation should be delayed until at least 6 weeks after the endarterectomy or stenting procedure performed on the symptomatic stenosis. You will need to repeat the screening procedures to make sure the patient is still eligible. In this case, when you screen the patient where the randomisation website asks ‘which artery is to be treated first’ give the asymptomatic artery as the artery to be treated first.
 In the case of a patient with bilateral asymptomatic stenosis, then choose the stenosis that is most severe as the randomised side to be treated first.

QUESTIONS ABOUT CAROTID IMAGING MODALITIES

If a centre screens a patient on ultrasound and there is no information if plaque is smooth or ulcerated, what should they assume?
Assume the plaque is smooth unless a definite ulcer is described in the ultrasound report. If another modality of imaging subsequently reports an ulcer, then re-do the screening prior to randomisation answering ‘yes’ to ulceration to check patient is still eligible for ECST-2. If ulceration is only found after randomisation, the patient should remain in the trial, but please send the imaging that has shown the ulcer to the central trial office.
My patient has had both carotid ultrasound and CTA (or MRA). Which result should I choose to enter on the CAR score app or when entering screening data on the website?
Please use the ultrasound results for the stenosis severity measurement, but if CTA or MRA report definite ulceration then reply ‘Yes’ to the ulceration question. If there is a big difference between the ultrasound and the CTA or MRA in the measurement of stenosis severity, you should discuss the findings with a radiologist to see which report is more accurate or whether further imaging is required. Patients should only be randomised after two non-invasive tests have confirmed a similar severity of stenosis or if the patient has had invasive catheter carotid angiography.We perform CTA as our first screening investigation and then do MRA (or vice versa) rather than doing carotid ultrasound. Which result should I choose to enter on the CAR score app or when entering screening data on the website?
If you don’t perform carotid ultrasound routinely, use the stenosis severity measurement from whichever other non-invasive test was done first.

Can we include people who only have stenosis in the CCA?
No, but they can be included if the stenosis started in the CCA and extends into the ICA.
Can we include people who have stenosis in the carotid bulb, but not in the ICA?
Yes, the carotid bulb or carotid sinus form the first part of the ICA.

Can we co-enrol with CTIMPs?
Usually no, but we will to consider on a case to case basis with sufficient information – contact the central office if you have a case to discuss.

Raised troponin level. Does this mean a troponin level that is higher than normal range or one that is higher than the baseline troponin?
Higher than normal range with the reference to your local laboratory range
What should centres do in patients with raised troponin with no symptoms or other findings?
Check that there are no changes in the ECG – silent myocardial infarction can occur without symptoms, especially in patients with diabetes. Check the patient’s renal function. Renal failure causes raised troponin levels. There are numerous other causes of raised troponin levels. If in doubt, ask a cardiologist’s advice.

Are blood pressures taken by the patients themselves in the GP surgery considered to be home blood pressures or clinic blood pressures?
Clinic blood pressure, the location of the blood pressure measurement is more important than who does it.
Do blood pressure medications taken in combination count as one or two medications e.g. telmisartan/hydrochlorothiazide taken in combination?
Record these as two separate medications.

Does an admission to A&E when discharged same day count as a hospital admission or other medical event?
It does not count as hospitalisation, but please complete the ‘Other medical or surgical event’ question on the follow up form as ‘Yes’ and give the details as ‘Admission to A&E’ and the reason for admission.
Does a procedure performed on the ward as a day case count as a hospital admission?
Yes, please complete the hospitalisation questions. You should record the date of admission and discharge as the same.

I do not know the exact date of the stroke what should I do?
When reporting a stroke, but the date of onset of the symptoms attributed to the stroke is unclear, please enter your best guess as to the date of onset on the stroke report form. If you know the month of onset, or have to estimate the month of onset but have no idea of the date, give the day of onset as the 15th of the month.
Should I report a "silent stroke" picked up on a scan??
No. Cerebral infarction reported on a scan without a history of appropriate symptoms should not be reported as a stroke. In the trial, we define stroke as an acute disturbance of focal neurological function with symptoms lasting more than 24 hours. However, you can report the scan finding in the next follow up form under the heading ‘other medical events’ giving the date as the date of the brain scan. Please send a copy of the report and the relevant brain scan to the central office so that it gets included in the analysis of silent infarction and haemorrhage.