Zusammenfassung:
Fragestellung: Es sollen Voraussetzungen, Sicherheit und Effektivität der systemischen Thrombolyse
mit rt-PA beim ischämischen Insult in einem universitären Versorgungskrankenhaus überprüft
werden. Methoden: Über einen Zeitraum von 2 Jahren und 10 Monaten wurden alle Patienten mit der Aufnahmediagnose
„Schlaganfall” prospektiv erfasst. Ein- und Ausschlusskriterien für die Behandlung
wurden nach den Erfahrungen der großen prospektiven Studien adaptiert. Erfasst wurden
die Zeitintervalle von Symptombeginn bis Krankenhausaufnahme, cCT und Lyse. Als Ergebnisparameter
wurden der Barthel-Index (BI) und die modifizierte Rankin-Skala (mRS) benutzt. Ergebnisse: Von Mai 1998 bis März 2001 wurden 103 Patienten lysiert. Dies entspricht 14,9 % aller
Patienten mit ischämischem Insult und 47 % aller Patienten mit ischämischem Insult,
die innerhalb von 3 h zur Aufnahme kamen. Bei Aufnahme betrug das Durchschnittsalter
70 (± 12) Jahre, der Median der NIHSS 14 (2 - 27) und der mRS 13 (3 - 34). Das Zeitintervall
Symptombeginn - Aufnahme betrug 64 min, die Tür-CT-Zeit 27 min, das Intervall Aufnahme
- Lysebeginn 80 min und die Zeit zwischen Symptombeginn und Lyse 142 min. Es ereigneten
sich 4 symptomatische hämorrhagische Transformationen, davon 3 Parenchymblutungen,
von denen 2 tödlich endeten, die dritte folgenfrei abheilte. Nach 3 Monaten hatten
39 % einen mRS von 0 - 1 und 60 % einen BI von 95 - 100 bzw. 72 % einen mRS von 0
- 2 und einen BI von > 90 erreicht. Die Sterblichkeit betrug 15 %. Schlussfolgerung: Die systemische Lyse mit rt-PA erfordert eine geeignete Organisation der Prähospital-
und der Aufnahmephase. Sie ist bei strenger Beachtung der Ein- und Ausschlusskriterien
sowie der Durchführungsrichtlinien auch unter den Bedingungen eines Versorgungskrankenhauses
eine sichere und effektive Behandlungsmethode des ischämischen Insultes, mit der ähnlich
positive Ergebnisse erzielt werden können, wie in der NINDS-Studie.
Prerequisites, Indications and Contraindications of IV-Lysis of Ischemic Stroke with
rt-PA:
Background and purpose: To evaluate prerequisites, safety, and efficacy of iv-thrombolysis of ischemic stroke
with rtPA in an academic medical center. Methods: Over a period of 2 years and 10 months all patients admitted with a diagnosis of
stroke were recruited. Inclusion and exclusion criteria for iv-thrombolysis were combined
from large scale randomized controlled trials, the time window, however, could be
extended up to 4 hours in subjects with a negative CT-scan. Prespecified outcome parameters
were the modified Rankin Scale (mRS) and the Barthel Index (BI) at 3 months, and symptomatic
hemorrhagic complications. Additionally, time parameters, such as onset-admission-time,
door-Ct-time, door-needle time, and onset-needle time were recorded. Results: During the reported period 103 patients underwent iv-thrombolysis, corresponding
to 14.9 % of all patients with ischemic stroke, and 47 % of patients with ischemic
stroke arriving in < 3 hours after symptom onset. The mean baseline NIHSS was 14,
the mean mRS 13 (3 - 34), the mean age 70 (± 12) years. The following time intervalls
were observed: Onset- admission-time 64 min., door-CT-time 27 min., admission-needle-time
80 min., and onset-needle-time 142 min. There were 4 symptomatic intracerebral hemorrhagic
transformations, including 3 parenchymal hemorrhages, 2 of them lethal, and one with
almost full recovery. According to the mRS, 39 % of patients had a good (mRS 0 - 1),
72 % a good to moderate recovery (mRS 0 - 2). The corresponding figures for the BI
were 60 % BI 95 - 100 and 72 % BI > 90. The mortality was 15 %. Conclusion: The iv-thrombolysis of ischemic stroke with rt-PA demands appropriate organisation
of the pre- and in-hospital phase and can be performed safely and efficaciously in
daily clinical routine if inclusion and exclusion criteria as well as all safety measures
during the critical phase after therapy are strictly obeyed.
Literatur
- 1
Tissue plasminogen activator for acute ischemic stroke. The National Institute of
Neurological Disorders and Stroke rt-PA Stroke Study Group [see comments].
1995;
333 (24)
1581-1587
- 2
Kwiatkowski T G, Libman R B, Frankel M. et al .
Effects of tissue plasminogen activator for acute ischemic stroke at one year.
National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen
Activator Stroke Study Group.
1999;
340 (23)
1781-1787
- 3
Hacke W, Kaste M, Fieschi C. et al .
Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric
stroke. The European Cooperative Acute Stroke Study (ECASS) [see comments].
JAMA.
1995;
274 (13)
1017-1025
- 4
Hacke W, Kaste M, Fieschi C. et al .
Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous
alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute
Stroke Study Investigators.
Lancet.
1998;
352 (9136)
1245-1251
- 5
Adams H P, Bendixen B H, Kappelle L J. et al .
Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter
clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment.
Stroke.
1993;
24 (1)
35-41
- 6
Grond M, Stenzel C, Schmulling S. et al .
Early intravenous thrombolysis for acute ischemic stroke in a community-based approach.
Stroke.
1998;
29 (8)
1544-1549
- 7
Koennecke H-C, Nohr R, Leistner S, Marx P.
Intravenous tPA for Ischemic Stroke Team Performance Over Time, Safety, and Efficacy
in a Single-Center, 2-Year Experience.
Stroke.
2001;
32 (5)
1074-1078
- 8
Leistner S, Boegner F, Marx P, Koennecke H C.
Transtentorial herniation after unilateral infarction of the anterior cerebral artery.
Stroke.
2001;
32 (3)
649-651
- 9
Albers G W, Bates V E, Clark W M. et al .
Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard
Treatment with Alteplase to Reverse Stroke (STARS) study [see comments].
2000;
283 (9)
1145-1150
- 10
Tanne D, Gorman M J, Bates V E. et al .
Intravenous tissue plasminogen activator for acute ischemic stroke in patients aged
80 years and older: the tPA stroke survey experience.
Stroke.
2000;
31 (2)
370-375
- 11
Wang D Z, Rose J A, Honings D S. et al .
Treating acute stroke patients with intravenous tPA. The OSF stroke network experience.
Stroke.
2000;
31 (1)
77-81
- 12
Barsan W G, Brott T G, Broderick J P. et al .
Urgent therapy for acute stroke. Effects of a stroke trial on untreated patients.
Stroke.
1994;
25 (11)
2132-2137
- 13
Alberts M J, Perry A, Dawson D V, Bertels C.
Effects of public and professional education on reducing the delay in presentation
and referral of stroke patients.
Stroke.
1992;
23 (3)
352-356
- 14
Tilley B C, Lyden P D, Brott T G. et al .
Total quality improvement method for reduction of delays between emergency department
admission and treatment of acute ischemic stroke.
The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group.
1997;
54 (12)
1466-1474
- 15
Chiu D, Krieger D, Villar-Cordova C. et al .
Intravenous tissue plasminogen activator for acute ischemic stroke: feasibility, safety,
and efficacy in the first year of clinical practice [see comments].
Stroke.
1998;
29 (1)
18-22
- 16
Fiorelli M, Bastianello S, von Kummer R. et al .
Hemorrhagic transformation within 36 hours of a cerebral infarct: relationships with
early clinical deterioration and 3-month outcome in the European Cooperative Acute
Stroke Study I (ECASS I) cohort.
Stroke.
1999;
30 (11)
2280-2284
- 17
Intracerebral hemorrhage after intravenous t-PA therapy for ischemic stroke.The NINDS
t-PA Stroke Study Group.
Stroke.
1997;
28 (11)
2109-2118
- 18
Larrue V, von Kummer R R, Muller A, Bluhmki E.
Risk factors for severe hemorrhagic transformation in ischemic stroke patients treated
with recombinant tissue plasminogen activator: a secondary analysis of the European-Australasian
Acute Stroke Study (ECASS II).
Stroke.
2001;
32 (2)
438-441
- 19
Hacke W, Warach S.
Diffusion-weighted MRI as an evolving standard of care in acute stroke.
Neurology.
2000;
54 (8)
1548-1549
- 20
Clark W M, Wissman S, Albers G W. et al .
Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to
5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial. Alteplase
Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke.
JAMA.
1999;
282 (21)
2019-2026
- 21
Clark W M, Albers G W, Madden K P, Hamilton S.
The rtPA (alteplase) 0- to 6-hour acute stroke trial, part A (A0276g): results of
a double-blind, placebo-controlled, multicenter study. Thrombolytic therapy in acute
ischemic stroke study investigators.
Stroke.
2000;
31 (4)
811-816
- 22
Marler J R, Tilley B C, Lu M. et al .
Early stroke treatment associated with better outcome: the NINDS rt-PA stroke study.
Neurology.
2000;
55 (11)
1649-1655
- 23
Chapman K M, Woolfenden A R, Graeb D. et al .
Intravenous tissue plasminogen activator for acute ischemic stroke: A Canadian hospital's
experience.
2001;
31 (12)
2920-2924
- 24
Lopez-Yunez A M, Bruno A, Williams L S. et al .
Protocol violations in community-based rTPA stroke treatment are associated with symptomatic
intracerebral hemorrhage.
Stroke.
2001;
32 (1)
12-16
- 25
Akins P T, Delemos C, Wentworth D. et al .
Can emergency department physicians safely and effectively initiate thrombolysis for
acute ischemic stroke?.
2001;
55 (12)
1801-1805
- 26
Katzan I L, Furlan A J, Lloyd L E. et al .
Use of tissue-type plasminogen activator for acute ischemic stroke: the Cleveland
area experience [see comments].
2000;
283 (9)
1151-1158
1 Herrn Prof. Dr. O. Hallen zum 80. Geburtstag gewidmet.
Prof. Dr. Peter Marx
Neurologische Klinik und Poliklinik und Klinische Neurophysiologie
Universitätsklinikum Benjamin Franklin
Freie Universität Berlin
Hindenburgdamm 30
12200 Berlin
eMail: E-mail: peter.marx@medizin.fu-berlin.de