Analysis of Workflow and Time to Treatment on Thrombectomy Outcome in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) Randomized, Controlled Trial

Abstract

Background— The Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial used innovative imaging and aggressive target time metrics to demonstrate the benefit of endovascular treatment in patients with acute ischemic stroke. We analyze the impact of time on clinical outcome and the effect of patient, hospital, and health system characteristics on workflow within the trial. Methods and Results— Relationship between outcome (modified Rankin Scale) and interval times was modeled by using logistic regression. Association between time intervals (stroke onset to arrival in endovascular-capable hospital, to qualifying computed tomography, to groin puncture, and to reperfusion) and patient, hospital, and health system characteristics were modeled by using negative binomial regression. Every 30-minute increase in computed tomography-to-reperfusion time reduced the probability of achieving a functionally independent outcome (90-day modified Rankin Scale 0–2) by 8.3% ( P =0.006). Symptom onset-to-imaging time was not associated with outcome ( P >0.05). Onset-to-endovascular hospital arrival time was 42% (34 minutes) longer among patients receiving intravenous alteplase at the referring hospital (drip and ship) versus direct transfer (mothership). Computed tomography-to-groin puncture time was 15% (8 minutes) shorter among patients presenting during work hours versus off hours, 41% (24 minutes) shorter in drip-ship patients versus mothership, and 43% (22 minutes) longer when general anesthesia was administered. The use of a balloon guide catheter during endovascular procedures shortened puncture-to-reperfusion time by 21% (8 minutes). Conclusions— Imaging-to-reperfusion time is a significant predictor of outcome in the ESCAPE trial. Inefficiencies in triaging, off-hour presentation, intravenous alteplase administration, use of general anesthesia, and endovascular techniques offer major opportunities for improvement in workflow. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01778335.

Vessel Patency at 24 Hours and Its Relationship With Clinical Outcomes and Infarct Volume in REVASCAT Trial (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset)

“…Although the precise time when revascularization occurred in control arm cannot be determined, it is likely that higher rates of early revascularization in the intervention group compared with control group could explain this finding because longer onset to reperfusion time has been associated with a reduced likelihood of good outcome in most trials examining the clinical benefit of reperfusion (intravenous or endovascular). [14][15][16] Our results are similar to those observed in SWIFT PRIME where patients who achieved successful reperfusion at 27 hours had more favorable clinical outcome than those who did not reperfuse regardless of treatment allocation with a trend toward better outcomes in successfully reperfused patients in the intervention group compared with controls. 11 Importantly, REVASCAT has shown a strong association between the degree of revascularization and the probability to become functionally independent at 90 days (Figure 2).…”

“…The analysis of vessel revascularization at 24 hours followed this methodology, but associations between revascularization at 24 hours with infarct volume and functional outcome were analyzed post hoc. [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]) at 24 hours and a higher rate of mortality (52.9% versus 13.8%) compared with those who did undergo follow-up imaging, and no significant differences were found regarding baseline clinical variables between the 2 groups.…”

Time for a Time Window Extension: Insights from Late Presenters in the ESCAPE Trial

“…6,7 The trial enrolled patients presenting within 12 hours from last seen healthy with disabling ischemic stroke, a small core infarct on noncontrast head CT (ASPECTS 6 -10), and moderate-to-good collaterals on CT angiography. 6,8 Because the 75th percentile for randomization to arterial access/groin puncture time was 28 minutes in the intervention group, patients randomized between 5.5 and 12 hours from last seen healthy (likely to undergo arterial access/groin puncture Ͼ6 hours from symptom onset/last seen healthy) were defined as the extended time window population for the current analyses.…”

Novel Distal Emboli Protection Technology: The EmboTrap

“…Studies have suggested that protective effects may be achieved using proximal flow control with a balloon guide catheter [8,9,10,11]. The ability of the stent retriever to retain the clot in the stent struts during clot retrieval is an important predictor of successful recanalization and may in part be affected by the device design.…”