SWIFT PRIME and REVASCAT Results Support Medtronic's Solitaire Stent Thrombectomy Device Added to IV-tPA for Acute Ischemic Stroke

April 17, 2015—Medtronic plc announced that two global trials, SWIFT PRIME and REVASCAT, found that the addition of the company’s Solitaire device stent thrombectomy procedure to current pharmaceutical treatment significantly reduced disability in stroke patients. The Solitaire device uses a transfemoral catheter to access cerebral arteries affected by stroke and help immediately restore flow and remove the associated clots.

The studies were published online ahead of print in The New England Journal of Medicine (NEJM) and presented at the European Stroke Organization Conference, which is being held April 17–19 in Glasgow, United Kingdom. 

The trials confirmed the findings of three previous trials also published in NEJM: EXTEND-IA, ESCAPE, and MR CLEAN. All of these trials have shown that the amount of time to treatment has a significant impact on outcomes, noted Medtronic. 

The SWIFT PRIME and REVASCAT trials assessed if patients experiencing an acute ischemic stroke and treated with the Solitaire device in addition to current medical therapy, including intravenous tissue plasminogen activator (IV-tPA) when patients were eligible, had less stroke-related disability than patients treated with IV-tPA or medical therapy alone.

SWIFT PRIME (Solitaire FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke) was published online by principal investigator Jeffrey L. Saver, MD, et al in NEJM. SWIFT PRIME was sponsored by Medtronic plc.

According to Medtronic, SWIFT PRIME assessed 196 patients and found that the addition of the Solitaire device significantly decreased poststroke disability and increased the number of patients who were independent within 90 days after a stroke. The trial found that the addition of the Solitaire device significantly increased patients' rate of return to functional independence compared to IV-tPA alone (60.2% vs 35.5%; P = .0002).

The company stated that SWIFT PRIME demonstrated dramatic improvements in workflow (the complete cycle of care from diagnosis through treatment) compared to previous trials, and it was conducted at 39 centers across seven countries, demonstrating broad applicability in different health systems and the achievability of fast, efficient stent thrombectomy care.

In Medtronic’s press release, Dr. Saver commented, “SWIFT PRIME showed that treatment with the Solitaire device is safe, technically successful, and substantially reduces long-term disability levels. This treatment marks the beginning of a new era in stroke care.” 

The REVASCAT (Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours) results were published online by study cochair Tudor G. Jovin, MD, et al in NEJM. REVASCAT was supported by an unrestricted grant from Medtronic.

Medtronic stated that the REVASCAT study, which enrolled 206 patients, showed that patients treated with the Solitaire device in addition to medical therapy (which included IV-tPA in eligible patients that comprised 70% of patients enrolled) up to 8 hours from onset of symptoms, experienced a statistically significant improvement in the rate of return to functional independence (43.7% vs 28.2%) in favor of patients treated with the Solitaire device when compared to medical therapy alone.

REVASCAT was conducted at four comprehensive stroke centers in Catalonia, Spain, covering a population of 7.5 million people. In looking at the overall population, 85% of the population of protocol-eligible patients were enrolled in the trial. The broad eligibility criteria and the high enrollment achieved in the REVASCAT trial, therefore, make the positive results of the Solitaire device highly generalizable to a sizable majority of those who experience strokes in Catalonia, advised Medtronic.

REVASCAT study cochair Antoni Davalos, MD, commented in Medtronic’s announcement, “We now have five global trials that provide an overwhelming body of clinical evidence in support of Solitaire stent thrombectomy. Based on these findings, it is time for the stroke community to come together to re-evaluate stroke treatment guidelines and to look for systems to facilitate the access of treatable patients to specialized centers.”

In February, Medtronic announced that the EXTEND-IA and ESCAPE studies were presented at the International Stroke Conference in Nashville, Tennessee. These studies found that stent thrombectomy using the Solitaire device added to IV-tPA treatment significantly reduced disability in patients experiencing a stroke. EXTEND-IA was published by Bruce C.V. Campbell, MD, et al in NEJM (2015;372:1009–1018). ESCAPE was published by Mayank Goyal, MD, et al in NEJM (2015; 372:1019–1030).

The MR CLEAN study was published by Olvert A. Berkhemer, MD, et al in NEJM (2015;372:11–20). The MR CLEAN investigators concluded that in patients with AIS caused by a proximal intracranial occlusion of the anterior circulation, intra-arterial treatment administered within 6 hours after stroke onset was effective and safe.