Two years and 300 carotid stenting procedures
In the beginning of November 2002, the Eurocast Registry reached the level of 300 carotid angioplasty and stenting procedures. Its one-year results have started being presented at meetings of reference and hopefully will keep on being talked about. No doubt that the whole endovascular medical community will soon take great advantage of this prospective tool. Joël Gay provides an update on Eurocast’s progress
2002, a busy year for Eurocast
Getting closer and closer to the end of this year, time has come to stop for a moment and have look at what happened in the history and the life of the Eurocast Registry. First of all, the most important point is that it has started to fit the goals it was given two years ago by its founding members: offer a reliable database for every physician and organisation involved in vascular health care. The Julius Center for Health Sciences and Primary Care in Utrecht (the Netherlands) asked three months ago whether they could utilise the data of the Eurocast registry, along with the CAVATAS and ECST databases, so as to provide their newly developed model of cost-effectiveness with enough data. The research team was given a grant from the Dutch Council for Medical Health Research to compare the cost-effectiveness of carotid angioplasty and stenting with conventional endarterectomy. Their work will probably start in December.
2002 has also been the year of communications in international congresses. Taking advantage of its 20 months of life, the Eurocast Registry is now recognised as an efficient tool to analyse and predict the outcome of stenting procedures. Marc
R H M van Sambeek from Erasmus University Medical Centre in Rotterdam, the Netherlands, presented the preliminary results of the registry in Phoenix on the occasion of the International Congress XV on Endovascular Interventions. Later in June, the Eurocast Registry proved its involvement in the field of endovascular therapy of the carotid artery. Taking advantage of the MEET 2002 (Marseilles - France), the MEET Directors published an original book entitled Carotid Artery Angioplasty & Stenting, which the Eurocast Registry was pleased to financially support.
“2003, let's make the year intense”
As the technology and the daily practice of endovascular procedures evolve, the Eurocast Registry has to be dynamic and adaptive, where all kinds of evolutions can find a place to be considered. Facing the increasing requests emanating from worldwide physicians to be part of the story, we decided to lighten the everyday work of physicians involved and to make the database more user-friendly. Therefore, we will soon make available downloadable pdf files concerning the inclusion and follow-up forms to best fit each one's habit when including patients. This will therefore increase the autonomy with which physicians will work with. These forms will be updated in a few weeks so as to make them better fit the current technology.
From a scientific point of view, as results from worldwide stenting procedures have become more and more numerous, more precise statistical needs appeared. The database may have now reached a large enough size to give a preliminary prospective dimension to its results. Therefore we have added some statistical filters so as to interpret the results in a prospective way. For example, one could predict, if further assessed, that patients presenting with hypertension, hostile necks and smoking habits may have more risk for fatal stroke within the 6 months following the procedure. Indeed life-table analysis gives fatal stroke freedom rates of 93.7%, 89% and 85.7% respectively while for the other risk factors, the survival rates are all 100%.
The activity of the registry also depends on its collaborations with other registries, medical societies and industrial partners. Aiming to develop from now on its reliability, the steering committee of the Eurocast Registry has started concerted discussions with Giorgio Biasi, Director of the newly built RISC Registry (Italian Registry for Carotid Stenting) so as to gather their data and enhance a close collaboration between the two series. This association, living unchanged the independence of both registries, will soon offer large and reliable data to the endovascular community interested in carotid stenting. As for the relationships with the industries, we will soon engage discussions and offer them a privileged area with technically explored results.
Back to initial goals
Many experts in the field have some concerns about the real efficacy and reliability of randomised controlled trials designed to compare conventional endarterectomy to endovascular procedures. Is it the most appropriate time to run such trials ? Ethical considerations and the state of current technology, significantly improving every single year, tend to argue that it is too early to carry out randomised clinical studies on carotid stenting.
The Eurocast Registry is the first existing prospective on-line registry where physicians, mostly from Europe, can include easily and quickly their patients treated with carotid angioplasty and stenting. The database has now begun to offer interesting and valuable results from the “intention to treat” step up to the estimation of the freedom from fatal strokes at two years. In between, it will certainly take part in defining the indications for carotid angioplasty and stenting, and will help evaluating the endovascular technique. But it may also play a role in the debate around the usefulness of the cerebral protection. Despite much of the results recently seen in the literature, Eurocast Registry may tend to prove that cerebral protection should not always been used, although its precise indications still remain to be identified. This being said, one should remember that protective devices have been available only for four years. The learning curve may not have reached its optimal point. Some recent works also argue that the optimal devices are not yet available, for both stents and protective devices. Join in:
www.euro-cast.org
Scientific contact: Joël Gay
Department of Cardio-Thoracic Surgery, Foundation Saint Joseph Hospital, 26, boulevard de Louvain
F-13 285 MARSEILLE CEDEX 08 - France
Phone : +33 491 806 618
Fax : +33 491 806 926
E-mail : jgay@hopital-saint-joseph.fr
A short history with significant results
Demographics
Since September 2000, 18 active centres from European and non-European countries have included more than 280 patients, of which 74% are males and 26% females. The selection of the patients depends on each physicians' own criteria, left to fully independent decision. The patients are mainly 70-80 years old (43.2%) with an average age of 70.7 years old, ranging from 42 to 88. Amongst the risk factors screened, hypertension represents the most common one (67.7%), followed by cardiac diseases (48%), hyperlipidaemia (46.7%), smoking (37.5%), vascular diseases (22.1%), diabetes (20%) and hostile necks (19.7%). Patients enrolled are mostly symptomatic (58.2%), essentially presenting with TIA (42.8%), motor deficit (28.9%) and amaurosis fugax (25.3%). Almost 75% of the lesions treated were de novo ones while 13% were recurrent stenoses after previous endarterectomy.
Aetiology and technique
Mainly located to the Internal Carotid Artery (65.4%) and to a less extend to the carotid bifurcation (26%), the narrowing of the lesions treated ranged from 70 to 90% in 66.4% of the cases. 58.5% of the procedure were achieved with cerebral protective devices, essentially with occlusive balloons (43.2%) and filters (39.3%), whereas Flow Reversal Systems only represent 15.5%.
Early and late results
The rates of all post-operative new neurological complications are respectively with and without cerebral protection of 9.7% and 8.1%. Analysing these results very carefully, it seems that more Major Strokes (2.6% versus 1.8%) were observed in patients treated with cerebral protection while the rate of Minor Strokes have decreased thanks to the protective devices from 2.7% to 1.9% and TIA rate doesn't seem to be affected (from 2.7% without cerebral protection to 2.6% with). However these results may be biased by a large number of patients with complications referred to as "Other". These represent 21.4% of the neurological complication observed in patients treated with cerebral protection and we don't know exactly what they are. Amongst peri-procedural complications, this series mentions only 3 cases of spasms (1%), 3 immediate stent thromboses and 1 vessel dissection (0.3%). Residual stenosis was observed in 43 cases (14.3%), of which the vast majority was less than 30% (93%). Life-table analysis shows a 1-year stroke survival rate of 96.7%. Descriptive statistics shows that 92% of the patients remain asymptomatic at 1 year post-procedure.
Conclusion
As shown by these results, and many other published works, carotid angioplasty and stenting may represent a reliable therapeutic option for some cohorts of patients, especially high risk patients, who would benefit from endovascular techniques as low risk patients do from conventional surgery. Nevertheless, clearly stated indications for carotid stenting are not yet defined and they will probably remain fuzzy until the practice and the technology remain sub optimal.
