Real-World Evidence Highlights Importance of Rapid Revascularization after Acute Ischemic Stroke

Large, population-based study validates previous results
VBCN - April 2014 Volume 1, No 1 - Stroke
Rosemary Frei, MSc

A large Spanish study conducted between January 2001 and December 2012 has provided real-world evidence confirming that revascularization is the strongest independent predictor of good outcomes after endovascular therapy (EVT) in patients who have had an acute ischemic stroke (Abilleira S, et al. Stroke. 2014 March 4. Epub ahead of print).

The research also corroborates results from earlier studies showing that outcomes are better in younger patients aged less than 80 years than older than 80 years; those who have mild or moderate stroke; have atrial fibrillation; do not have hypertension; and have an onset-to-groin-puncture time of ≤6 hours.

“All patients undergoing endovascular therapies in Catalonia throughout the study period were included in the study, since there is an external monitoring of completeness, and any undeclared case is included retrospectively,” Principal Investigator Sònia Abilleira, MD, PhD, a researcher for the Stroke Programme of the Catalan Health Department, told Value-Based Care in Neurology. “Thus, this is not a single-center study; this is an observational, population-based study, and therefore, quite robust.”

Dr Abilleira and colleagues conducted this large study to evaluate clinical outcomes after EVT in real-­world conditions rather than in the confines of a clinical trial. They used information from an online registry that was launched in January 2011 in the region of Catalonia, Spain, called SONIIA. Their study is one of several using data from SONIIA that is exploring the benefits of EVT in patients with ischemic stroke, as part of the Endovascular Revascularization with Solitaire Device versus Best Medical Therapy in Anterior Circulation Stroke within 8 Hours (REVASCAT) trial.

Many patients with acute ischemic stroke are left untreated because they either arrive late to the hospital or are receiving treatment but do not receive revascularization. There is a need to consider whether more patients should undergo this procedure. This study is part of an ongoing effort to determine the role of revascularization in this patient population based on real-world evidence.

Study Details
This new analysis included 536 patients who had an acute ischemic stroke and then had EVT at 1 of 7 comprehensive stroke centers in SONIIA. A total of 54.9% of the patients were men, the patients’ mean age was 67.5 years, and the median baseline National Institutes of Health Stroke Scale score was 17.5.

The vast majority of patients—485 (90.5%)—had mechanical thrombectomy. Of the other patients, 40 (7.5%) had combined pharmacologic-mechanical procedures, and the other 11 (2%) patients had intra-arterial thrombolysis. Furthermore, 285 (53%) patients had received previous EVT. The median onset-to-groin-puncture time was 277 minutes, and the median EVT duration was 95 minutes.

Overall, 73.9% of the EVT procedures successfully resulted in revascularization, whereas 5.6% were associated with symptomatic cerebral bleeds.

The researchers performed a series of logistic regression analyses that revealed that revascularization was associated with an odds ratio of 8.12 for a favorable outcome, defined by a modified Rankin Scale score of 0, 1, or 2. It was also a strong independent predictor of reduced all-cause mortality (odds ratio, 0.21).

Other protective factors were younger age, shorter onset-to-groin-puncture time, anterior circulation stroke, prestroke modified Rankin Scale score of 0 or 1, and the presence of atrial fibrillation.

Earlier studies have uncovered all of these various components associated with this EVT-related picture, but none has been as large or comprehensive, pointed out Dr Abilleira.

“It is also important to say that all tertiary hospitals in Catalonia are currently involved in the REVASCAT trial,” she said. “The coexistence of the registry and the trial will enhance knowledge on the real-world outcomes of neurointerventional treatment of stroke.”

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