STRATIS Data Validate Outcomes and Real-World Application of Medtronic's Solitaire Stent Retriever

February 23, 2017—Medtronic plc announced that data presented on the company's Solitaire stent retriever demonstrated that the results from four pivotal randomized controlled trials can be replicated in United States centers in a pragmatic, real-world setting, reconfirming the benefits of mechanical thrombectomy in patients with acute ischemic stroke (AIS). Study investigators presented the results from the STRATIS (Systematic Evaluation of Patients Treated with Neurothrombectomy Devices for Acute Ischemic Stroke) registry at the International Stroke Conference in Houston, Texas.

The Solitaire stent retriever, which uses a microsized catheter to access arteries in the brain to help restore blood flow and remove large blood clots causing AIS, was evaluated in four pivotal clinical studies that were published in The New England Journal of Medicine (NEJM): SWIFT PRIME (NEJM 2015;372:2285–2295); ESCAPE (NEJM 2015;372:1019–1030); EXTEND IA (NEJM 2015;372:1009–1018); and REVASCAT (NEJM 2015;372:2296–2306).

According to Medtronic, STRATIS focused on the impact of systems of care on clinical outcomes. Investigators examined the impact of treatment delays on patient outcomes when treated with the Solitaire stent retriever and intravenous tissue plasminogen activator (IV tPA), if eligible. In the study, 984 patients were enrolled at 55 centers in the United States; 64% were treated with the Solitaire stent retriever and IV tPA and 36% were treated with the Solitaire stent retriever alone.

The study found that interhospital transfer was associated with significant delays to treatment and significantly lower chance of functional independence at 90 days (60% vs 52.2%; P = .02). Patients treated via balloon guide catheter had higher rates of functional independence at 90 days (61.8% vs 50.2%; P = .002) with fewer passes (1.7 vs 2.0; P = .0008) than patients treated via distal access catheter, reported Medtronic.

In the company's announcement, Curtis Given, MD, commented, “The STRATIS registry confirms that the outcomes from four of the global randomized clinical trials that helped to transform stroke treatment are applicable in different health systems across the US with the same positive results. We are consistently seeing that access to stent retrievers reduces long-term disability in patients. We must continue to work toward a system that makes early treatment with this technology available to all patients.”

In addition to confirming real-world application, a recently published evaluation of SWIFT-PRIME by Theresa I. Shireman, PhD, et al in Stroke (2017;48:379–387) found that treatment with both the Solitaire stent retriever and IV tPA is very cost-effective and an economically dominant strategy that results in substantial long-term cost savings and gains in both life expectancy and quality-adjusted life expectancy compared to IV tPA alone.

Jeffrey L. Saver, MD, commented in the Medtronic announcement, “The cost-effectiveness data show that despite higher initial treatment costs, in the long run, patients who receive stent retriever therapy with the Solitaire stent retriever spend less time in the hospital, less time in rehabilitation, and less time in nursing home care after an acute ischemic stroke. Patients have faster and complete recoveries, and the healthcare system saves money overall."