MINNEAPOLIS, Nov. 18, 2014 /PRNewswire-USNewswire/ -- It is a momentous time for patients with blockage-type brain attacks (aka acute ischemic stroke). The SVIN attendees had the privilege of witnessing history in the making at the SVIN's 7th Annual Meeting in Hollywood, Florida from November 6-9, 2014. Breaking news shared during the meeting will undoubtedly mark a turn-around point for the world of endovascular stroke therapy represents fulfillment of longstanding hopes by physicians and millions of stroke patients and their caregivers that proof of effective stroke treatment beyond intravenous clot dissolving medications (IV t-PA) is finally within tangible reach.
Interim results of the FIRST study (International study including US; n=93 patients) presented at the SVIN meeting, reiterated the malignant nature of large vessel occlusions in stroke patients with majority of the patients dying or becoming disabled despite clot dissolving medications. Clearly, there is an unmet need for more effective clot retrieval devices. With regards to the role of endovascular clot retrieval therapies for treatment of stroke, the stage had been set by the MR CLEAN trial (Dutch trial; n=500 patients) whose results were presented at the 9th World Congress of Stroke in Istanbul from October 22-25, 2014, showing robust superiority of clot retrieval devices compared to standard medical therapy consisting largely of IV t-PA. This triggered an unplanned interim analysis of other ongoing trials including ESCAPE (Canadian trial; n=243 patients) and EXTEND IA (Australian trial; n=70 patients); both of them were stopped by their respective Data Safety Monitoring Boards (DSMB's) due to overwhelming benefit in favor of endovascular clot retrieval devices.
There are several other randomized trials that have been placed on hold pending results of interim analyses. Joe Broderick, MD, a leading stroke neurologist, illustrated this domino effect by presenting a line of dominoes falling sequentially, representing ESCAPE, EXTEND IA, SWIFT PRIME and THERAPY. Predicting that results from other ongoing trials are likely to go in the same direction, Jeff Saver, MD, UCLA, a veteran of endovascular stroke trials, stated that given the recent slew of positive trials "it doesn't matter how you design it, it will be positive".
At present it is hard to fathom the impact of these studies, but it is likely that the landscape of acute stroke care will be changed forever. If magnitude of treatment effect is confirmed by other ongoing studies and once data appear in published form, clot retrieval for blockage type brain attacks will likely change very quickly from an optional to a mandatory procedure that patients and emergency medical service (EMS) providers will demand. Healthcare systems will need to invest in their infrastructure and resources for brain attack care to provide for these services similar to heart attack and trauma centers.
Credit for this great accomplishment must be given to the community of stroke neurologists and stroke interventionalists among whom interventional neurologists occupy a prominent role. It was particularly impressive to note the high number of SVIN Board members occupying leadership positions in most of the stroke trials presented. Important preliminary work done by IMS-3 trial has made possible improvement in design and execution of future trials and also created equipoise, enabling randomization of patients that would otherwise never have been enrolled in a randomized trial.
Obviously there is more work to be done and huge opportunities exist to improve stroke outcomes even further. Imaging based selection outside of the 6 hour time window; development of stroke networks and systems of care that will allow this treatment to be carried out in the fastest possible manner; combination of reperfusion with neuroprotection; and benefit in octogenarians are some of the questions that need to be further studied.
Because the results of these trials are not yet available in peer reviewed publications, enthusiasm has to be tempered until definitive proof of efficacy is published. It is important to not discourage recruitment in any ongoing trials like REVASCAT and THRACE where available evidence has not been considered sufficiently strong to recommend halting. The conundrum however remains that personal equipoise has in many cases already ceased to exist. However, unequivocal evidence must still be accrued in order to win not just a battle but the war in a field where attrition has held sway for far too long.
About the Society of Vascular & Interventional Neurology:
The SVIN traces its roots to the neurologist Egaz Moniz, who performed the first cerebral angiogram in 1927. Stroke and Critical Care Neurologists performing catheter-based endovascular interventions including clot retrieval are now an integral part of the multidisciplinary field of Endovascular Surgical Neuroradiology (aka Interventional Neurology). In 2002, the Accreditation Council for Graduate Medical Education (ACGME) formalized the eligibility of neurologists to obtain training in "Endovascular Surgical Neuroradiology" along with neurosurgeons and neuroradiologists. Since then, an increasing number of neurologists have entered the field and the number continues to grow. This burgeoning group of interventional neurologists formed a new neurological society called "Society of Vascular and Interventional Neurology" (SVIN) in August 2006. The founding members of SVIN felt that the formation of the society would help pursue the group's mission: To promote excellence in the field of interventional treatment of neurovascular diseases by neurologists. For further information, please visit www.svin.org.
SOURCE Society of Vascular and Interventional Neurology