Societies Respond to Publication of MR CLEAN Trial Data

December 17, 2014—The Society of Neurointerventional Surgery (SNIS) and the European Society of Minimally Invasive Neurological Therapy (ESMINT) have commented on the publication of the MR CLEAN study online in The New England Journal of Medicine, which demonstrated that the addition of intra-arterial clot removal is more effective than intravenous-administered tissue plasminogen activator (IV-tPA, alteplase) therapy alone for the treatment of stroke. On December 22, leaders of the Society of Vascular & Interventional Neurology (SVIN) issued a statement on the MR CLEAN data.

In the SNIS press release, society President Peter Rasmussen, MD, commented, “The MR CLEAN study confirms what we are seeing in everyday practice. Within-the-artery procedures, which are performed by neurointerventional surgeons, are not the appropriate treatment for every patient suffering from stroke, but for many patients they are life-saving, viable, and effective therapies that offer many benefits over traditional treatments, including shorter recovery times and a better chance to return to normal activities.” Dr. Rasmussen is director of the Cerebrovascular Center at the Cleveland Clinic in Cleveland, Ohio.

SNIS President-Elect Donald Frei, MD, added, “MR CLEAN is an important milestone in the transformation of care for stroke patients, but it is not the end of the story. Neurointerventional surgery is a relatively young and rapidly changing field that typically outpaces clinical research, and we need to ensure that these treatments—their success evident in thousands of lives saved—continue to be evaluated in clinical trials. We are confident that when designed and implemented correctly, clinical studies will continue to show positive results.”

According to Dr. Frei, MR CLEAN is the most significant randomized, controlled stroke treatment study since the NINDS-2 trial in 1995—published by The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group in The New England Journal of Medicine (1995; 333:1581–1588)—and subsequent US Food and Drug Administration approval of IV-tPA, which revolutionized stroke care, but must be administered within 4.5 hours. Neurointerventional surgery can be performed up to 6 hours from the onset of stroke, significantly expanding the treatment window, advised Dr. Frei.

Dr. Frei also noted that the death rates from stroke had decreased by more than 35% from 2000 to 2010 because of a stroke care system of neurointerventional surgical treatment as well as public education to reduce risk factors and recognize the symptoms of stroke, emergency medical services processes and protocols to appropriately assess patients, and emergency transport guidelines that immediately get stroke patients to a hospital that is equipped to provide the best evidence-based interventions for ischemic and hemorrhagic stroke management.

In a statement on the ESMINT website, the society noted, “[R]esults of the MR CLEAN trial are strongly positive towards intra-arterial therapy and will have a major impact on the future treatment of ischemic stroke. The ESMINT strives towards a scientifically funded use of endovascular techniques in neurovascular pathology, by suitably trained and skilled medical specialists. In this respect the ESMINT applauds the researchers for their work and welcomes the outcome of the trial wholeheartedly.”

However, the society advised, “ESMINT also warrants restraint since these complex endovascular procedures are highly operator dependent and should not be executed by persons without appropriate training and neurovascular knowledge. Execution of these procedures by anyone other than endovascularly trained neurovascular specialists poses a risk, both for the patients and the future of this technique. Awareness of these risks is of the utmost importance to both legislators and hospital administrations that may consider employing doctors lacking the necessary training. Centralization of this particular service needs to be considered and may well be the only way to achieve the trial results in routine practice.”

In a separate press release, ESMINT President Istvan Szikora, MD, commented, “We are very pleased to see that the benefits of this treatment method have been demonstrated scientifically. With these results, it is hoped that the number of patients treated with this new method will increase so the best possible care can be provided to patients suffering from this disease.”

The ESMINT announcement emphasized that such treatment is only indicated for a selected group of patients and should be performed by specially trained physicians—neurointerventionists. In addition, these patients must be treated in dedicated centers with around-the-clock service and a fully trained, multidisciplinary team.

Dr. Szikora noted, “At present there may not be enough trained physicians everywhere in Europe with the resources to handle the potential demand for this new treatment. To address this challenge, ESMINT has announced a new professional, accredited training course, ECMINT, that will be run from Oxford in the United Kingdom.”

ECMINT, the European Course in Minimally Invasive Neurological Therapy, covers all the basic knowledge necessary for using minimally invasive techniques to treat vascular diseases of the brain, including stroke.

ECMINT is a 2-year program for trainees in interventional neuroradiology and endovascular neurosurgery. The course is comprehensive with a curriculum compliant with the guidelines published by the specialist section of UEMS: European Union of Medical Specialists.

The program teaches trainees all components needed to practice the subspecialty. Teaching is by an international faculty during four residential periods of 5 days each. These will be held at St. Anne’s College, Oxford. Students are encouraged to complete all four periods in sequence, but completion of each element will be credited for continuing medical education points. The ESMINT accreditation committee will undertake certification of students completing the course.

The first course, ECMINT 1, is being held December 14–19, 2014. The second, ECMINT 2, will convene June 24–28, 2015, with the third and fourth courses scheduled, respectively, for December 14–18, 2015, and June 21–25, 2016. Additional information is available online at http://www.esmint.eu/training-education/teaching-course.

In the SVIN statement, society President Tudor Jovin, MD, commented, "MR CLEAN is a ground breaking trial and the results will undoubtedly change the way we treat brain attacks moving forward.” Vallabh Janardhan, MD, added, “The majority of the stroke patients with large vessel occlusions will either die or become disabled for life despite clot dissolving medications. It is essential to have cutting-edge clot retrieval devices for brain attacks.” Dr. Janardhan is Principal Investigator of the FIRST study, which is a natural history study on outcomes in stroke patients.