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Three Trials Demonstrate Benefit of Endovascular Thrombectomy for Major Stroke
On the heels of the MR CLEAN trial data published in late 2014, three studies presented in February at the International Stroke Conference in patients with major ischemic stroke who received endovascular thrombectomy after administration of tissue plasminogen activator demonstrated better outcomes compared with control treatment.
EXTEND-IA
In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue, early thrombectomy with the Solitaire FR stent retriever (Covidien) was associated with improved outcomes compared with alteplase only. Researchers randomly assigned patients receiving alteplase 0.9 mg/kg of body weight less than 4.5 hours after ischemic stroke to endovascular thrombectomy or continued alteplase alone. When the trial was stopped, 70 patients (35 in each group) of a planned 100 had undergone randomization.
A median of 100% of patients in the intervention group had undergone reperfusion at 24 hours vs. 37% of controls (P < .001), and the proportion of patients with reperfusion >90% at 24 hours was 89% vs. 34%, respectively. Eighty percent of the intervention group had early neurologic improvement, defined as a reduction of 8 points or more on the NIH Stroke Scale or a score of 0 or 1 at 3 days, vs. 37% of controls (P = .002). Functional independence at 90 days, based on modified Rankin scale score, was reported in 71% of the intervention group vs. 40% of controls (P = .01).
ESCAPE
Researchers for ESCAPE reported that rapid endovascular treatment reduced mortality and improved functional outcomes in imaging-selected patients with acute ischemic stroke who had a proximal vessel occlusion, a small infarct core and moderate-to-good collateral circulation. The trial included 316 patients randomly assigned to standard care or standard care plus use of available thrombectomy devices. Of the 151 patients assigned endovascular treatment, 130 received a retrievable stent, and 100 of those received the Solitaire stent retriever. In total, 238 patients (120 in intervention group, 118 in control group) received alteplase.
Functional independence at 90 days was reported in 53% of the intervention group vs. 29.3% of controls (P < .001). The primary outcome of modified Rankin scale score at 90 days favored thrombectomy (OR = 2.6; 95% CI, 1.7-3.8). Thrombectomy was also associated with reduced mortality (10.4% vs. 19%; P = .04).
SWIFT PRIME
In this trial, researchers investigated whether patients with acute ischemic stroke due to large vessel occlusion treated with IV tissue plasminogen activator (tPA) and the Solitaire FR or Solitaire 2 device had less stroke-related disability compared with patients treated with IV tPA alone.
At 90 days, the intervention group had 17.3% of patients with a modified Rankin scale score of 0, 25.5% with 1, 17.3% with 2, 12.2% with 3, 15.3% with 4 and 12.2% with 5 or 6, vs. 8.6%, 10.8%, 17.2%, 21.5% and 25.8%, respectively, in controls (P = .0002). Functional independence at 90 days was 60.2% in the intervention group vs. 35.5% in controls (OR = 2.75; 95% CI, 1.53-4.95). Mean improvement in NIH Stroke Scale at 27 hours was 8.5 vs. 3.9, respectively (P < .0001).="">
Other Results
The data demonstrate no significant differences in symptomatic intracerebral hemorrhage in any trial or mortality in the EXTEND-IA and SWIFT PRIME trials.
All three trials were stopped early due to efficacy. – by Erik Swain
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Perspective
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These studies add to the recently published Dutch MR CLEAN study and herald a very welcome change in acute stroke care, with the possibility that at least some patients with large strokes treated at specialty centers will experience much improved recovery and independence.
The ESCAPE and EXTEND-IA trials suggested that even more improvement in outcomes might occur after stent retrieval than in MR CLEAN. However, a few important issues need to be considered. ESCAPE incorporated a very high rehabilitative care standard, with patients immediately hospitalized in stroke units with staffs including physicians with ‘expertise/core training’ in rehabilitation and therapists using evidence-based care practices. EXTEND-IA was also carried out at stroke units known for a very high standard of acute stroke rehabilitative care. Unfortunately, many U.S. stroke patients do not have access to rehabilitation physicians and teams trained in evidence-based care until after they leave the hospital, or may never have this access. Patients who are treated with new technologies may also need to start rehabilitation from day 1, as patients did in the ESCAPE and EXTEND-IA studies.
The functional outcome measures used in these studies (NIH Stroke Scale and Rankin Scale) can miss hidden disability, and that could be why the presence of early, skilled rehabilitation is important. I am concerned that broadly applying stent retrieval without building infrastructure, to identify hidden disabilities and deliver evidence-based rehabilitation, could actually increase the number of people with hidden disabilities. This gives us a ‘good problem’ and a good challenge: Focus on creating care pathways for stroke survivors who look fine, but who have increased risk for falls, medication management, driving errors and work challenges.