Guest Post from Clemens M. Schirmer, MD, PhD, FAANS, FAHA
AANS/CNS Cerebrovascular Section
Wilkes Barre, PA
Acute ischemic stroke due to a blockage of a larger vessel in the brain is a common medical condition and is potentially devastating to the patients. Over the last decade, incremental improvements in stroke care have resulted in improved outcomes, but even with these advancements, there was more work to be done. It has been a long stretch, and almost a test of faith, for many of the supporters and practitioners who provide endovascular interventions — amongst them many cerebrovascular and endovascular neurosurgeons — who felt they could deliver better results.
A near death blow was delivered two years ago when three trials published in the New England Journal of Medicine concluded that endovascular interventions, in addition to the standard treatment, did not provide any significant benefit. Despite this initial set-back, innovations continued, and the positive results were recently unveiled at the 2015 International Stroke Conference in Nashville, TN. Three randomized controlled trials — ESCAPE, EXTEND-IA, and SWIFT PRIME — all demonstrated that, for acute ischemic stroke caused by large vessel occlusions, mechanical thrombectomy combined with intravenous thrombolysis using a “clot buster” drug (alteplase or tPA) improves functional outcomes compared with intravenous administration of tPA alone. Not all patients in the ESCAPE trial were eligible for intravenous therapy and received otherwise standard care. Two of the trials named ESCAPE and EXTEND-IA have also been published online in the New England Journal of Medicine. Publication of the SWIFT PRIME trial is anticipated soon, after the presentation during the plenary session at the International Stroke Conference.
Not only did all three trials show improved outcomes, the results were so dramatic they were all stopped early after independent reviews by data safety monitoring boards following the results of the Dutch MR CLEAN trial. The MR CLEAN trial also found that the addition of endovascular therapy improved functional outcomes when compared to treatment with IV tPA alone. Collectively, these four trials refute the much-criticized negative results of the IMS III, MR RESCUE, and SYNTHESIS Expansion trials published in February 2013. These trials are testament to the tenacity of the primary investigators of each trial and to the work of endovascular and cerebrovascular neurosurgeons.
It’s our hope that these landmark studies will bring increased treatment options to the nearly 800,000 people per year in the United States who suffer a stroke. However, despite these clinical advances, patients do not have access to this lifesaving treatment because health insurers have labeled mechanical thrombectomy as “investigational” and hence not covered or reimbursable. Given the overwhelming evidence now available, organized neurosurgery is calling on all insurance companies to immediately revise policies that continue to prevent access to this lifesaving procedure. Neurosurgeons hope that equipped with this data, we can change these policies and focus on building systems of care that are designed around this new evidence.
For everyone performing neuroendovascular procedures, these are extremely exciting times. Now begins a new era of stroke trials that will help us find quicker ways to identify patients who will benefit from these interventions.