PHANTOM-S study Prehospital acute neurologic therapy and optimization of medical care in stroke Matthias Wendt on behalf of the PHANTOM-S study group

Recent guidelines

1. Intravenous rtPA (0.9 mg/kg, maximum dose 90 mg) is recommended for selected patients who may be treated within 3 hours of onset of ischemic stroke (Class I; Level of Evidence A). 2. In patients eligible for intravenous rtPA, benefit of therapy is time dependent, and treatment should be initiated as quickly as possible (Class I; Level of Evidence A). 3. Intravenous rtPA (0.9 mg/kg, maximum dose 90 mg) is recommended for administration to eligible patients who can be treated in the time period of 3 to 4.5 hours after stroke onset (Class I; Level of Evidence B).

tPA effects are time dependent SITS-MOST-Registry: Proportion of patients according to OTT

NNT 4.5

NNT 9

NNT 14

11%

Wahlgren N et al, Lancet 2008

Lees K et al, Lancet 2010

Starting situation Thrombolysis rate in Germany:

~ 5-10%

Thrombolysis rate in 14 Berlin Stroke Units:

12% (2010)

54 min

pre-hospital

in-hospital

98min

Bolus

44min Admission

Alarm

times in 50 consecutive tPA treatments in Charité 2010

The vision of prehospital thrombolysis

Laboratory Med. History

BodyCheck

NeuroExam

Venous line CTExam

30 min ?

STEMO-concept Preconditions for tPA

STEMO components

Discrimination to other diseases

Neurologist as an emergency physician

Exclusion of hemorrhage/tumor

Compact CT with teleradiology

Exclusion of coagulation disorders

Point of care laboratory

Imaging of vessel occlusion

CT-angiography

External view

Inside view

Deployment process Deployment via stroke identification algorithm Dispatch Center

 Accuracy for stroke and TIA:

59%

 Frequency of neurological diseases: 79% Krebes S et al. Stroke 2012

Objectives and Hypothesis  Primary: Reduction of time from alarm to treatment

 at least 20 minutes  Secondary outcomes:  tPA treatment rate  Safety (stroke and non-stroke): 7d mortality and hemorrhages  Process quality

 Relevance of effects on local stroke population 3-month pilot study 2011

(Weber et al., Neurology, 2013):

• 23 prehospital tPA treatments

• Time from alarm-to-treatment: 62 min • No safety concerns

Study design • Prospective controlled study: 1 special ambulance, multiple hospitals • Inclusion criteria:  Acute stroke suspected by dispatchers

 Expected arrival at scene within 16 min (with 75% probability)  Age ≥ 18 y

Methods  Random allocation of STEMO- and control weeks C

S

C

S

S

C

S

C

S

C

S

C

S

C

S

C

C

S

C

S

C

S

C

S

C

S

C

S

 Patient delivery to closest adequately equipped hospital

 Ethics and data protection (approved by Berlin authorities) • Informed consent on STEMO (tPA was given also in Patients who were unable to give their informed consent) • De-identified data collection from external hospitals • 3-month FU only from tPA patients

Inclusion from 01.05.2011 to 31.01.2013: 10.5 months in both groups Included patients N=7098

STEMO-weeks

Control weeks

N=3668 in 322 days

STEMO deployed N=2027

N=3430 in 320 days

STEMO not deployed N=1641

No transport to hospital N=117 (6%)

No transport to hospital N=132 (8%)

No transport to hospital N=276 (8%)

Incomplete hospital data N=106 (5%)

Incomplete hospital data N=100 (6%)

Incomplete hospital data N=186 (5%)

Cared in STEMO N=1457

Evaluable patients N=1804

Evaluable patients N=1409

Documentation from 28 hospitals

Evaluable patients N=2968

Results 1: Total deployments

STEMO deployed

STEMO weeks

Control weeks

N=1804

p

N=3213

p

N=2965

Age (years)

74

0.39

74

0.33

74

Male gender

44%

0.45

44%

0.50

45%

Diagnosis groups Non-neurological

31%

Neurological / non-stroke

21%

Strokes and TIA

48%

31% 0.35

22%

29% 0.19

47%

22% 49%

tPA in Stroke-Mimics

0.3%

0.43

0.2%

0.97

0.2%

In-hospital death

3.4%

0.32

3.6%

0.43

4.0%

Results 2: Stroke patients STEMO deployed

STEMO weeks

Control weeks

N=866

p

N=1516

p

N=1457

Age (years)

76

0.56

76

0.89

76

Male gender

45%

0.87

45%

0.90

46%

Subtypes TIA

21%

22%

22%

Ischemic stroke (AIS)

71%

71%

71%

0.94

0.87

Hemorrhagic stroke

5%

5%

5%

Others

3%

2%

2%

Transport to hospital with Stroke Unit

95%