New study shows addition of stent thrombectomy more effective than traditional pharmaceutical treatment for acute ischemic stroke patients

In a landmark study evaluating the addition of stent thrombectomy clot removal to pharmaceutical treatment for patients suffering an acute ischemic stroke (AIS), stent thrombectomy provided a significant clinical benefit when compared to pharmaceutical treatment alone. Results from the Multi center Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (MR CLEAN) have been published online and will appear in the January 1 issue of The New England Journal of Medicine ("NEJM"). Findings were also presented at the World Stroke Congress, confirming the effectiveness of stent thrombectomy.

The MR CLEAN study evaluated 500 patients suffering from moderate to severe strokes and demonstrated that the addition of stent thrombectomy during early treatment doubled the likelihood of a good neurological outcome. The study also confirmed that there was no increased safety risk with the addition of the procedure.

"The results of MR CLEAN demonstrate that the addition of stent thrombectomy to current pharmaceutical treatment provides a significant clinical benefit to patients," said Professor Diederik Dippel, Erasmus Medical Center, Rotterdam. "However, there is much work yet to be done in the fight against this devastating disease, and we would welcome confirmation of our findings in additional randomized studies."

One of the stent thrombectomy technologies studied in MR CLEAN was the Solitaire™ device developed by Covidien plc. The Solitaire device thrombectomy procedure uses a micro sized catheter to access arteries in the brain affected by stroke through an incision in the leg. Once delivered, the Solitaire device helps to immediately restore blood flow and remove the blood clots causing the stroke. The results of the MR CLEAN study confirm results observed from earlier stage Solitaire device stent thrombectomy studies Solitaire With the Intention for Thrombectomy (SWIFT) and Solitaire™ FR Thrombectomy for Acute Revascularization (STAR).

Covidien currently supports a number of clinical studies that are further investigating the addition of stent thrombectomy to traditional pharmaceutical treatment for AIS. Data from the Solitaire FR as Primary Treatment for Acute Ischemic Stroke (SWIFT PRIME), Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) and Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT) studies will be presented in early 2015.

"We continue to support the clinical evaluation of this breakthrough technology through several additional randomized controlled clinical trials like SWIFT PRIME, ESCAPE and REVASCAT that will look to confirm and validate the MR CLEAN results," said Brett Wall, president, Neurovascular, Covidien. "We remain committed to furthering the body of clinical evidence that drives best medical practice and improved patient outcomes, and we believe that the MR CLEAN study suggests that stent thrombectomy is an important treatment option that should be made available to patients suffering from moderate to severe stroke."

According to the World Heart Federation, of the 15 million people who experience a stroke worldwide each year, nearly six million die and another five million are left permanently disabled. For patients who miss the 0-3 hour window for treatment with pharmaceutical treatment such as tissue plasminogen activator (tPA) or for those patients with large vessel occlusion for which tPA has very limited efficacy, additional therapy such as stent thrombectomy may be the only treatment option.

Stroke and Stent Thrombectomy Device Background & Key Points

The Solitaire Device is a stent thrombectomy device that combines the ability to restore blood flow to the brain and retrieve clots in patients experiencing acute ischemic stroke (AIS) within eight hours of symptom onset.

According to the World Heart Federation, of the 15 million people who experience a stroke worldwide each year, nearly six million die and another five million are left permanently disabled.

Research shows that the current standard of care, IV t-PA, has very limited efficacy in large vessel occlusions with an 8 to 40 percent chance of recanalization in large vessels.

Decreasing the amount of time needed to re-establish blood flow to the affected areas of the brain is vital. The sooner a patient has access to the drug IV tPA and/or stent thrombectomy the better their chance of a good outcome.