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

Transcription

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

2 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).

3 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

4 Alarm Starting situation Admission Bolus Thrombolysis rate in Germany: ~ 5-10% Thrombolysis rate in 14 Berlin Stroke Units: 12% (2010) times in 50 consecutive tpa treatments in Charité min pre-hospital 54 min in-hospital 98min

5 The vision of prehospital thrombolysis Laboratory Med. History Body- Check Neuro- Exam Venous line 30 min? CT- Exam

6 STEMO-concept Preconditions for tpa STEMO components Discrimination to other diseases Exclusion of hemorrhage/tumor Exclusion of coagulation disorders Imaging of vessel occlusion Neurologist as an emergency physician Compact CT with teleradiology Point of care laboratory CT-angiography

7 External view

8 Inside view

9 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

10 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

11 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

12 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 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

13 Inclusion from to : 10.5 months in both groups Included patients N=7098 STEMO-weeks N=3668 in 322 days Control weeks N=3430 in 320 days STEMO deployed N=2027 STEMO not deployed N=1641 No transport to hospital N=117 (6%) 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%) Cared in STEMO N=1457 Evaluable patients N=1804 Evaluable patients N=1409 Evaluable patients N=2968 Documentation from 28 hospitals

14 Results 1: Total deployments STEMO deployed STEMO weeks Control weeks N=1804 p N=3213 p N=2965 Age (years) Male gender 44% % % Diagnosis groups Non-neurological 31% 31% 29% Neurological / non-stroke 21% % % Strokes and TIA 48% 47% 49% tpa in Stroke-Mimics 0.3% % % In-hospital death 3.4% % %

15 Results 2: Stroke patients STEMO deployed STEMO weeks Control weeks N=866 p N=1516 p N=1457 Age (years) Male gender 45% % % Subtypes TIA 21% 22% 22% Ischemic stroke (AIS) 71% 71% 71% Hemorrhagic stroke 5% 5% 5% Others 3% 2% 2% Transport to hospital with Stroke Unit 95% < % < % iv.-tpa rate (from AIS) 33% < % < % In-hospital death 3.8% % %

16 Results 3: tpa treatments STEMO deployed STEMO weeks Control weeks in N=201 STEMO N = 184 p N=312 p N=218 Age (years) Male gender 46% % % Severity (NIHSS; median [IQR]) Alarm-to-needle-time (mean) Complications 8 [5-17] [5-15] [4-13] in STEMO 52min < min < min 48 min Intracranial hemorrh. 3.5% % % In-hosp. death within 7 d 4.5% % %

17 Acceleration of treatment Zeit Alarm von Alarmierung to treatment bis time Lysebeginn Ausgangslage Starting situation (2010) min Standard- Regular care Versorgung min Lysen im STEMO STEMO care min Ambulance (prehospital) Hospital Minuten Minutes STEMO Rettungsdienst Klinik

18 Real time benefit? Onset-to-treatment-time compared to regular care SITS-MOST 11% 64% % of treatments SITS-MOST STEMO minutes from onset

19 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)

20 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)

21 is teamwork! STEMO-team and neuroradiologist 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

22 Merci beaucoup pour votre attention!

23 Disclosures 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). Co-funding by the European Union (European Regional Development Fund)

24 Our learning curve Alarm to treatment times (mean times) 70,0 60,0 50,0 minutes 40,0 30,0 20,0 10,0 0,0 1. quartile 2. quartile 3. quartile 4. quartile

25 Interview algorithms for acute stroke identification at the dispatch center. Krebes S et al. Stroke 2012;43: Copyright American Heart Association

26 Accompanying effects Alarm: 19:42 Arrival: 19:59 GCS: 13 CCT: 20:36 INR: 2, IE PPSB Transport to Virchowhospital

27 Accompanying effects Day 0 (OP) Day 18 Arrival CVK: 21:00 GCS: 5 Left side mydriasis INR: 1,52 OP: 21:40 Day 36 Status 4 months after incidence: No focal neurology Slightly slowed down Patient at home Day 131