1. Direct catheter-based thrombectomy in acute ischemic stroke
PRAGUE-16 pilot study
Petr Widimský, Boris Kožnar, Tomáš Peisker, Peter Vaško, Jana Vavrová, Ivana Štětkářová.
Departments of Cardiology and Neurology
University Hospital Kralovske Vinohrady &
Third Faculty of Medicine, Charles University Prague, Czech Republic

2. Potential conflicts of interest
Speaker's name: Petr Widimsky
 I receive occasional honoraria from:
Abbott Vascular, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer
Ingelheim, Daiichi Sankyo, Eli Lilly, Medtronic, Sanofi, Servier.
No conflict of interest is related to this study and/or to this presentation.

3. Background
• Randomized trials with thrombolytic treatment of acute stroke provided controversial results (5/7 of
them were neutral or negative)
• Randomized trials with pharmaco-invasive therapy (thrombolysis and/or intervention) were also neutral (3 trials published in NEJM, March 2013)
• Recently, the new stent-retrievers (catheter-based thrombectomy) suggest promissing results:
• 75-90% recanalization rates (compared to 25-50% recanalization after thrombolysis)

4. ! Clinical suspicion for acute ischemic stroke EMS transfer to CT
EMS  neurologist  cath-lab nurse (on-site 24/7)  radiologist + cardiologist (info, if not on-site,
EMS transfer to CT
prepar totravel !) e
CT scan (± CT angio)
Cath-lab preparation
+ interventional radiologist +
cardiologist arrival
Ideally the interventionalist should arrive to cath-lab before or simultaneously with the patient. !
Patient transfer from CT to cath-lab
No intubation
Femoral artery sheath insertion (unless absolutely indicated)

5. Entry criteria: <100 000) wake-up • Exclusion criteria:
• New onset of acute stroke symptoms (NIHSS ≥8)
• Previously known moderate- severe neurologic symptoms
• Symptom onset - CT time <6 hours
• Known coagulation disorders (INR >1,7, thrombocytes
< )
• Wake-up stroke possible if CT performed within <2 hours after
• Known severe hypoglycemia
wake-up
• Gravidity (?)
• Availability of angiography (cath- lab + staff) <30 minutes after CT
• History of intracranial bleeding
• Age years

6. Study end-points • Recanalization rate (angiography)
• ΔNIHSS (admission - discharge)
• mRS after 90 days
• 90-days mortality
• CT (admission - final)
• Symptomatic intracranial bleeding (ΔNIHSS ≥4)

7. Patients baseline characteristics (period 10/2012 - 1/2014)
• Age (mean 64.8)
• Females: 48 %
• Anterior strokes: 100 %
• Admission NIHSS: (mean 17)

8. Time delays Interval Mean [min.] Range [min.] Symptom onset - CT 81
CT - sheath 47
Sheath - reperfusion 46
Total ischemic time (symptom
211
onset - reperfusion)

9. Clinically relevant complications•
30-day mortality: 13%
(3/23) •
90-day mortality: 21.7% (5/23)
• 2 pts: symptomatic intracranial hemorhage (NIHSS increase ≥ 4) - one of them received thrombolysis
• sICH rate among d-CBT (no lytics, n=18): 5,5%
• sICH rate among f-CBT (lytics + CBT, n=5): 20%

10. Functional outcomes mRS at 90 days6
mRS at 90 days 5 5 2 4
3,19 5 3
2,31 3 2 1 2 3 1 1
mRS
Admission
90 days all 1 2 3 4 5 6
90 days survivors
Favourable outcome (mRs ≤2) in 11 pts. (48%).
7 patients (30%) discharged directly home (no need for in-hospital rehabilitation) Mean mRs among survivors treated within <120 minutes was 1.17 !

11. Despite the learning curve, our results are similar to
endovascular treatment arms in the 3 largest randomized
trials (NEJM March 2013) 90 81 80 70
59 58 60 52 50
Mortality 40
Death / severe disability Mean mRS at 90 days 30
* *
21,7
19,1 18,8 20
14,4 10
PRAGUE-16
IMS-III trial MR Rescue SYNTHESIS trial trial
*SYNTHESIS included pts. with small strokes (NIHSS ≥2)
* * MR-Rescue included pts. with NIHSS ≥6

12. Comparison of matched groups
Mechanical vs. pharmacological reperfusion %
20 matched individuals, treated by iv. thrombolysis (IVT) 90
Mean age 64 years, mean NIHSS 16
80 All 40 patients had a hyperdense sign of middle cerebral artery 80
on the initial CT scan. 70
Mean onset - needle time: 140 min (CBT) vs. 143 min (IVT). 60 50 45
CBT 40
IVT 30 30 20 20 10
Recanalization mRs 0-2 at 3 months

13. C