ESCAPE trial: use of clot retrieval devices + guideline management vs guideline management alone in patients with ischemic stroke. 

N=316, 22 centers (international)
Study design: prospective, randomized, open-label treatment, blinded outcome evaluation. Current-guideline based controls (no sham control). No specified clot retrieval method.
Disclosures: funded by Covidien.
Inclusion Criteria: 
- Adults, no upper age limit
- Ischemic stroke with onset of symptoms within 12 hours
- Previously normally functioning (Barthel > 90)
- Small infarct core on CT (ASPECTS 6-10)
- Good collaterals on CTA (>50% filling of pial MCA territory vessels)
- Proximal occlusion (M2 or more proximal)
Data adjusted for: use of thrombolytics, age, sex, baseline ASPECTS, baseline NIHSS, location of clot.
Primary outcome: modified Rankin score at 90 days
Modified Rankin:
- 0 : no deficit
- 1 : some deficit, but still able to carry out all activities of daily living (ADL)
- 2 : not able to carry out all ADLs but able to carry out most
- 3 : needs assistance for most ADLs, but able to walk and care for own bodily functions
- 4 : no ADLs, not able to walk or care for own bodily functions
- 5 : bedridden, incontinent, requires 24 hour nursing care
- 6 : dead
Secondary outcome: time to reperfusion/recanalization, hemorrhage, neurological disability at 90 days, death.

Results: 

"The median 90-day modified Rankin score was 2 in the intervention group and 4 in the control group (P<0.001).  The proportion of patients with a modified Rankin score of 0 to 2 at 90 days was 53.0% in the intervention group and 29.3% in the control group (rate ratio, 1.8; 95% CI, 1.4 to 2.4; P<0.001)." (Goyal et al)

Complications: 

The incidence of asymptomatic hemorrhage-infarct was higher in the intervention group (data not shown) but there was no significant difference in symptomatic/significant parenchymal hemorrhage between control and intervention! Woooo 

Speed: goal CT to groin puncture <60 mins, CT to recanalization < 90 mins

 "Although eligibility criteria allowed enrollment up to 12 hours after symptom onset, the median time from symptom onset to first reperfusion was 241 minutes. A total of 49 participants (15.5%) underwent randomization 6 or more hours after symptom onset, and the study was not powered to assess endovascular therapy among patients presenting 6 to 12 hours after symptom onset"

Limitations: 

- Unclear generalizability - unknown how many people were screened and determined to be ineligible based on having too large of an infarct, insufficient collaterals, poor prior function level etc. The significantly devastated people, with the giant infarcts and poor collaterals, the ones who will likely end up rankin 5-6, I wonder if these people may be more vulnerable to hemorrhagic conversion - I don't know... Something to look up next. If they are, the the risk/benefit of clot retrieval in these patients may be more difficult to ascertain-- i.e. they need it more because their injury is more devastating, but their complication rate may be higher making intervention not worth it. 

- The timing was impressive (84 mins CT to recanalization) and may not be reproducible. However MR CLEAN was slower and still had positive outcomes with clot retrieval.