GVI One of the Leaders in Landmark International Clinical Trial

In February 2015, results from a $50 million international clinical trial, led in the United States by principal investigator Elad I. Levy, MD, MBA, FACS, FAHA, from the Gates Vascular Institute, were recently released. The results of this landmark trial will revolutionize stroke treatment world-wide and will have a dramatic impact on patient recovery and survival rates.

Called SWIFT PRIME, the trial was conducted to determine if patients who experienced an ischemic stroke had better outcomes through the use of intravenous t-PA alone (a clot busting protein), versus t-PA in conjunction with the use of Covidien’s SolitaireTM FR Revascularization Device. The trial examined the use of Solitaire within six hours of symptom onset.

Ischemic stroke occurs as a result of an obstruction within a blood vessel supplying blood to the brain. It accounts for 87 percent of all stroke cases.

“This was a ground breaking study that will have an immense impact on the lives of patients who’ve experienced an acute ischemic stroke,” said Adnan Siddiqui, MD, PhD, FAHA, FAANS, professor and vice chairman of neurosurgery at the University at Buffalo (UB), who served as site principal investigator for the trial at the Gates Vascular Institute.

Dr. Siddiqui added, “The findings were definitive. When Solitaire is used along with t-PA, patients have the best chance for survival and return to normal function.”

What is the SolitaireTM FR Revascularization Device and how does it work?

Solitaire is a wire mesh stent device that is inserted through a tiny incision in the groin and threaded through the femoral artery by catheter to the vessel in the brain that’s blocked. When the mesh device is opened, it captures the clot and pulls it out as the catheter is removed. Normal flow to the brain is restored and damage to the brain due to lack of blood is mitigated.

For the clinical trial, t-PA was administered to the patient prior to the Solitaire procedure. SWIFT PRIME was initially slated to include nearly 90 of the most prestigious neuroscience programs in the United States and Europe and more than 800 patients. However, because it was overwhelmingly clear from the start that Solitaire, in conjunction with t-PA, appeared to be the most effective treatment, a randomized controlled study was fast tracked. Ultimately, 36 programs met the participation criteria and together they enrolled 196 patients. The Gates Vascular Institute was one of the top three enrollment sites for the trial.

“This trial establishes a whole new standard of care for treating ischemic strokes,” said Dr. Levy, the medical director for neuroendovascular services, Gates Vascular Institute, co- director, Gates Stroke Center at Kaleida Health and chair and professor of neurosurgery at UB. “It restores blood flow to the brain far faster and provides the patient the absolute best chance for a positive outcome.”

According to Medscape.com, results of the trial, which were presented last week at the International Stroke Conference, showed that when people were treated with t-PA in conjunction with Solitaire, 88% of patients experienced successful revascularization (vessel was opened to allow blood to flow) and of those patients, 60% regained good function. These numbers are staggering when compared to the use of t-PA alone, which has a revascularization rate of only about 35%.

The role of work flow efficiency

When EMS responds to a suspected stroke call, they activate the Gates Vascular Institute’s Stroke Team right from the field so the team is waiting in the Emergency Department when they arrive with the patient. The team performs a CT perfusion study which allows them to visualize where the clot is located and what portion of the brain is not receiving blood.

“Once we review the scan results, the patient is in a procedure lab within an hour. This is remarkably fast and is a direct result of the work flow efficiency here at the Gates Vascular Institute,” said Kenneth Snyder, MD, PhD, assistant professor of neurosurgery at UB. “Our neurosurgeons treat more strokes at the Gates Vascular Institute than any other hospital in all of New York State. We are highly skilled at managing a high volume case load and that experience has allowed us to fine tune the care process to ensure optimal results.”

With the opening of the first-of-its-kind Gates Vascular Institute, Buffalo and Western New York have officially become a destination of choice for stroke, cardiac and vascular care. From providing revolutionary neurological and stroke procedures to performing cardiac services unavailable anywhere else in the area, some of the most innovative medicine in the country – and the world – is being performed right here, at the Gates Vascular Institute.