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

NNT

14

NNT

4.5

NNT

9

11%

Lees K et al, Lancet 2010 Wahlgren N et al, Lancet 2008

SITS-MOST-Registry: Proportion of patients according to OTT

Starting situation

Thrombolysis rate in Germany: ~ 5-10%

Thrombolysis rate in 14 Berlin Stroke Units: 12% (2010)

98min

44min

pre-hospital

54 min

in-hospital

Ad

mis

sio

n

Ala

rm

Bo

lus

times in 50 consecutive tPA treatments in Charité 2010

Labor-

atory

Med.

History

Body-

Check

Neuro-

Exam Venous

line

CT-

Exam

30 min ?

The vision of prehospital thrombolysis

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 via stroke identification algorithm

Dispatch Center

Accuracy for stroke and TIA: 59%

Frequency of neurological diseases: 79%

Krebes S et al. Stroke 2012

Deployment process

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

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

C S C S

C S C S

S C S C

C S C S

Inclusion from 01.05.2011 to 31.01.2013:

10.5 months in both groups

STEMO-weeks

No transport

to hospital

N=117 (6%)

Control weeks

Incomplete

hospital data

N=106 (5%)

No transport

to hospital

N=132 (8%)

Incomplete

hospital data

N=100 (6%)

No transport

to hospital

N=276 (8%)

Incomplete

hospital data

N=186 (5%)

Evaluable

patients

N=1804

Evaluable

patients

N=1409

Evaluable

patients

N=2968

N=3668

in 322 days

STEMO

not deployed

N=1641

STEMO

deployed

N=2027

N=3430

in 320 days

Documentation from 28 hospitals

Included patients

N=7098

Cared in

STEMO

N=1457

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%

0.35

31%

0.19

29%

Neurological / non-stroke 21% 22% 22%

Strokes and TIA 48% 47% 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%

0.94

22%

0.87

22%

Ischemic stroke (AIS) 71% 71% 71%

Hemorrhagic stroke 5% 5% 5%

Others 3% 2% 2%

Transport to hospital

with Stroke Unit 95% <0.01 93% <0.01 87%

iv.-tPA rate (from AIS) 33% <0.01 29% <0.01 21%

In-hospital death 3.8% 0.41 4.4% 0.90 4.5%

Results 3: tPA treatments

STEMO

deployed

STEMO

weeks

Control

weeks

N=201 p N=312 p N=218

Age (years) 77 0.25 76 0.40 75

Male gender 46% 0.59 50% 0.85 49%

Severity (NIHSS;

median [IQR]) 8 [5-17] 0.02 8 [5-15] 0.09 7 [4-13]

Alarm-to-needle-time

(mean) 52min <0.01 62min <0.01 77min

Complications

Intracranial hemorrh. 3.5% 0.25 4.8% 0.58 6.0%

In-hosp. death within 7 d 4.5% 0.83 4.5% 0.82 4.1%

in STEMO

48 min

in STEMO N = 184

Zeit von Alarmierung bis Lysebeginn

48

35

42

42

53

0 20 40 60 80 100 120

Lysen imSTEMO

Standard-Versorgung

Ausgangslage

Minuten

STEMO Rettungsdienst Klinik

95 min

76 min

48 min

Acceleration of treatment

Alarm to treatment time

Starting situation

(2010)

Regular care

STEMO care

Minutes

Ambulance (prehospital)

Hospital

0

2

4

6

8

10

12

14

16

18

-10

-30

-50

-70

-90

-110

-130

-150

-170

SITS-MOST

STEMO

Onset-to-treatment-time compared to regular care

SITS-MOST

11%

64%

% of

treatments

Real time benefit?

0

2

4

6

8

10

12

14

16

18

-10

-30

-50

-70

-90

-110

-130

-150

-170

SITS-MOST

STEMO

minutes

from onset

Limitations

Randomisation of weeks, not at patient level

Evaluation of one prehospital facility („monocentric“)

No 3-month outcome (will be provided as functional

outcome for patients with informed consent (only STEMO

patients)

Summary and conclusions

STEMO concept

can be integrated in a metropolitan EMS

safe (for all patient groups)

superior to regular care regarding

Quality of care

Proportion of patients receiving tPA

Time to treatment

Effects remain relevant after inclusion of cases who could not

be managed by STEMO

Further potentials (ICH, triage for interventional treatment)

is teamwork! Dispatch Center

Project partners (Berliner Feuerwehr, BRAHMS, CSB, MEYTEC)

Technology Foundation Berlin for funding

Berlin hospitals for their outstanding cooperation

Berlin and it‘s citizens for their openness

STEMO-team and neuroradiologist

Merci beaucoup pour

votre attention!

Disclosures

Co-funding by the

European Union

(European Regional Development Fund)

The STEMO project has been funded by the Technology Foundation

Berlin with co-funding by the European Union.

The Center for Stroke Research Berlin (CSB) is funded by the German

Federal Ministry for Education and Research (BMBF).

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

1. quartile 2. quartile 3. quartile 4. quartile

minutes

Alarm to treatment times (mean times)

Our learning curve

Interview algorithms for acute stroke identification at the dispatch center.

Krebes S et al. Stroke 2012;43:776-781

Copyright © American Heart Association

Alarm: 19:42

Arrival: 19:59

GCS: 13

CCT: 20:36

INR: 2,2

1200 IE PPSB

Transport to Virchow-

hospital

Accompanying effects

Arrival CVK: 21:00

GCS: 5

Left side mydriasis

INR: 1,52

OP: 21:40

Day 0 (OP)

Day 18

Day 36

Day 131

Status 4 months after incidence:

•No focal neurology

•Slightly slowed down

•Patient at home

Accompanying effects