Mr.CLEAN trial supports stent retriever with IV tPA use in clot busting Stroke treatment- Stryker-Covidien

The Mr CLEAN trial investigators found that using intra-arterial treatment to remove a stroke-causing blood clot in a large vessel supplying blood to the brain provides better outcomes than trying to dissolve the clot using a clot-busting drug (lytic) alone. One of the devices used in the trial was Stryker's Trevo Retriever and the other the Solitaire device from Covidien.

The MR CLEAN trial (Multicenter Randomised Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands) was a prospective, randomized, multi-center trial that compared the effect of intra-arterial treatment with standard treatment for medical care, which could include the lytic IV tPA (intervenous alteplase) if indicated. This clot-busting drug (intravenous alteplase) was administered through an intravenous injection � the current standard of care for these patients. Intra-arterial treatment could consist of IA lytics or mechanical treatment, however in the majority of the patients in the trial a stent retriever was used. In this procedure, the stent retriever is inserted into the patient's femoral artery starting in the leg and navigated to the site of the blood clot in the brain � once in place, the physician grabs the clot with the device and removes it.

The results show that, in the control arm of the study, the current standard treatment results in good outcomes only 19 per-cent of the time as characterized by a Modified Rankin Score of 0-2. The treatment arm, using the newest generation of stent retrievers in conjunction with clot busting drugs, was almost twice as likely to result in a good outcome. While these results only apply to the subset of stroke patients who could be treated within six hours of onset and had a blood clot in the forward-most (anterior) arteries of their brain, that population accounts for a large number of stroke victims. As many as 125,000 patients in the US and 90,000 in Europe arrive at the hospital with this type of stroke annually.

See- "A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke"- Olvert A. Berkhemer, M.D.,et al. for the MR CLEAN Investigators December 17, 2014DOI: 10.1056/NEJMoa1411587.