ACST-2... world* but we as a. lots more patients! is nearly the biggest investigator-led trial in the. collaborative group. must keep recruiting

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1 ACST-2... is nearly the biggest investigator-led trial in the world* but we as a collaborative group must keep recruiting lots more patients! So far in 2013 a total of 72 patients have been recruited into ACST-2 (well done!). To become the biggest (and best) we need to recruit another 40 patients. This would represent a major milestone on our journey to randomise around 5000 patients in ACST-2 and enable us to answer important questions about good practice in carotid interventions. * comparing CEA vs CAS in patients with asymptomatic carotid stenosis

2 Page 2 Newsletter ACST-2: a world-class carotid intervention study comparing CEA vs CAS in patients with asymptomatic carotid stenosis. Together we can improve carotid practice for everyone. March 2013 Collaborative Group Monthly Targets As a Collaborative Group, we must increase our monthly recruitment total. So far, we have been recruiting ~25-30 patients each month. This is good, but it could be better! To reach our target of 5000 faster, we want to recruit at least 40 patients EACH month. If every centre in ACST-2 recruited just one patient in a month, the monthly total would be well over 80 patients randomised! The graph below shows our recruitment over the last 5 months. Collaborative Group target: >40 patients a month ACST-2 Collaborators Meeting Our ACST-2 Collaborators Meeting takes place on the 4th & 5th April 2013 in the historic Exeter College, Oxford. We have an exciting programme with speakers from around the world, a champagne reception in the Divinity School (featured in the Harry Potter Films) and a Gala Dinner on Thursday evening. We look forward to welcoming you to Oxford soon! Further details can be found on our website:

3 Page 3 Data Monitoring Committee The ACST-2 Data Monitoring Committee (DMC) Meeting will take place on the 28th March Thank you all for your hard work in sending back any outstanding Consent, Randomisation & 1-Month Follow-up forms. Your hard work has paid off! Consent Form (received) Randomisation Form (received) 96% 96% 94% 1-month followup form (received) Annual Follow-Up Forms Connie, Carol & Lynda have recently been in contact with some of you about missing 2012 Annual Follow-Up Forms. It is really important we receive all outstanding forms before the DMC Meeting. Thank you to those sites who have already returned several missing forms. In the last 2 weeks we have seen a ~20% increase in completeness of data. Our target is 85% before our Data Monitoring Committee Meeting. Please help us achieve this! Recruitment Update: 1147 patients to date! Istituto Auxologico Italiano, Milan, Italy Dedinje Cardiovascular Unit, Belgrade, Serbia University of Bari, Italy Hospital Ceské Budejovice, Czech Republic University of South Manchester, UK University Hospital of Antwerp, Belgium Santa Maria Hospital, Reggio Emilia, Italy University La Sapienza, Rome, Italy Serbian Clinical Centre, Belgrade, Serbia Freeman Hospital, Newcastle, UK Albert Szent-Györgyi Medical Centre, Szeged, Hungary Lasarettet Helsingborg, Hälsningar, Sweden Sodersjukhuset, Stockholm, Sweden University Hospital Utrecht, The Netherlands Sheffield Vascular Institute, UK St Anne's University Hospital Brno, Czech Republic Centre de Consultation Cardiovasculaire, Nimes, France Rambam Medical Centre, Haifa, Israel NOCSAE Modena, Italy Hospital Clinic 1 Provincial De Barcelona, Spain University of Basel, Switzerland Bishop Auckland Hospital, Durham, UK Kent and Canterbury Hospital, UK Nottingham University Hospital, UK Southend University Hospital, UK Luton & Dunstable Hospital, UK These centres recruited 47% of patients entered in January & February. Well done to ALL 26 sites who have recruited patients so far. Keep recruiting lots more patients!

4 Page 4 S I T E N E W S! We are delighted to welcome new sites into ACST-2:- Carotid Trials Collaboration ACST-2 hope to develop collaborations with SPACE-2, ECST-2 & CREST-2. It is exciting times for us all and we will keep you informed of future developments. Medical Center Leeuwarden, The NL HagaZiekenhuis Locatie Leyenburg, The NL Cheltenham Hospital, UK* Rijnstate Hospital, Arnhem, The NL* *In final stages of set up Site in focus: Albert Szent-Györgyi Medical Centre, Hungary Albert Szent-Györgyi Medical Centre, Hungary joined ACST-2 in March 2010 and have recruited a fantastic 26 patients into ACST was their best year so far. Their PI, Dr. Bela Fulop explains why: In 2012 a Neurovascular Team was formed with Neurosurgeons from our Department and a Neuroradiologist (responsible for checking our vascular patients every week). This meant that all our asymptomatic patients were monitored by the Vascular Team closely and potentially eligible patients were discussed by the whole team. We believe that the cooperation between Neurosurgeons and Neuro-interventional Physicians can lead to a better health care management of vascular patients thereby resulting in successful recruitment rates During these meetings we discussed the medical conditions of all patients with symptomatic and asymptomatic carotid stenosis. In 2012 we performed 160 CEA (mortality and morbidity rate < 0,5%) and 65 CAS (mortality and morbidity rate < 2%). Dr. Bela Fulop IMPORTANT MEETINGS Japanese Society for Surgery for Cerebral Stroke: 20-24th March 2013 Tokyo, Japan ACST-2 Collaborators Meeting: 4th & 5th April 2013 Exeter College, Oxford Charing Cross, Olympia, UK: 6-9th April 2013 SITE Symposium, Barcelona: 8-11th May 2013 Alison will present The controversy continues: Is there any rationale for randomized trials comparing CEA and CAS for asymptomatic patients? on Friday 10th May at 08:30am LIVE Symposium, Thessaloniki, Greece: 23-26th May 2013 Alison will present Lessons learnt from the trials on asymptomatic carotid disease: What don t we know? on Saturday 25th May at 11:00am European Stroke Conference (ESC), London: 28-31st May 2013 European Society of Vascular Surgeons (ESVS), Budapest: 18-20th September 2013

5 Page 5 Here to help you. The ACST-2 Team are to help in any way we can! If you have any questions, please don t hesitate to contact us on:- Tel: +44 (0) acst@nds.ox.ac.uk Remember! We are no longer based at St Georges Hospital in London. Our full postal address is: Asymptomatic Carotid Surgery Trial-2 Nuffield Department of Surgical Sciences University of Oxford Level 6, John Radcliffe Hospital Headington Oxford OX3 9DU United Kingdom Website: Thank you all for your continued hard work all in this important Carotid Intervention Study!

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