Adding Solitaire thrombectomy to treatment with intravenous tPA significantly improves functional outcomes in stroke patients and reduces mortality in patients over age 80, researchers report.

The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain affected by stroke through an incision in the leg. Once delivered, the device helps to immediately restore blood flow and remove blood clots.

In June 2015, The American Heart Association/American Stroke Association published updated stroke treatment guidelines that recommended the use of stent-retriever technology in conjunction with IV-tPA as a first-line treatment for appropriate patients.

For the study, the researchers pooled data from four global clinical trials. Studies were eligible for analysis if they were randomized trials of endovascular thrombectomy added to best medical therapy versus best medical therapy alone, with the Solitaire device used first in all or a majority of the interventions. Data from a total of 787 patients was assessed. Of those, 77 percent had successful revascularizations.

Patients treated with the device had significantly improved independent functional outcomes 90 days after treatment compared with patients treated with IV-tPA alone, as demonstrated by modified Rankin Scale ratings of 0-2. A time-benefit relationship was also demonstrated, with a decline in the probability of an independent functional outcome with longer time from symptom onset to reperfusion. The analysis also showed that patients over age 80 and otherwise in good health had a statistically significant 20 percent reduction in mortality.

“The degree of benefit conferred is substantial, with 40 of every 100 patients treated having reduced disability as a result of thrombectomy, including 23 patients achieving an independent outcome. No major safety concerns were noted, with no increase in symptomatic hemorrhage or mortality,” the authors write.

“The current study compares the use of Solitaire to what was at that time the standard of care,” senior author Dr. Mayank Goyal of the University of Calgary, Alberta, Canada told Reuters Health by email.

The reported success of the device and the revised AHA/ASA guidelines have “spurred innovation, and we are already seeing the development of a number of these devices to accomplish the removal of clots,” he observed. Although there currently are no plans to compare the Solitaire to other stent retrievers, he added, “various new trials are being planned which, if successful, would allow us to help more patients.”

Dr. Robert Glatter, an emergency physician and director of sports medicine and traumatic brain injury at Lenox Hill Hospital in New York City, told Reuters Health by email that the Solitaire device “has proven to be a valuable tool” in the emergency department.

“Trials indicate that a larger percentage of patients than initially thought will benefit from expanded treatment with a stent-retrieval device in the setting of continued obstruction of a large vessel by a blood clot even after tPA is administered,” he said.

Dr. Glatter, who was not involved in the study, also noted that “an estimated 240,000 of the nearly 700,000 ischemic stroke victims in the U.S. are eligible for treatment using clot-retriever technology. However, the data indicates that only about 13,000 procedures were performed in U.S. hospitals over the past year. Based on this, there appears to be an opportunity to potentially treat a greater number of patients.”

Medtronic, which sells the Solitaire system, funded the study. Dr. Goyal and other coauthors have received additional fees from the company.