Comparison of intravenous alteplase with a combined intravenous-endovascular approach in patients with stroke and confirmed arterial occlusion (RECANALISE study): a prospective cohort study.
BACKGROUND
The efficacy of intravenous (IV) alteplase is restricted by the speed of recanalisation and the site of the occlusion. The aim of this study was to ascertain the effect of a combined IV-endovascular approach (intra-arterial alteplase and, if required, additional thrombectomy) in patients with stroke due to arterial occlusion.


METHODS
We compared recanalisation rates, neurological improvement at 24 h, and functional outcome at 3 months between two periods (February, 2002, to March, 2007, vs April, 2007, to October, 2008) in patients in a prospective registry who were treated with different regimens of alteplase within 3 h of symptom onset. Patients with confirmed occlusion who were treated before April, 2007, were treated with IV alteplase; after April, 2007, patients were treated with a systematic IV-endovascular approach. Analysis was by intention to treat.


RESULTS
46 (87%) of 53 patients treated with the IV-endovascular approach achieved recanalisation versus 56 (52%) of 107 patients in the IV group (adjusted relative risk [RR] 1.49, 95% CI 1.21-1.84; p=0.0002). Early neurological improvement (NIHSS score of 0 or 1 or an improvement of 4 points or more at 24 h) occurred in 32 (60%) patients in the IV-endovascular group and 42 (39%) patients in the IV group (adjusted RR 1.36, 0.97-1.91; p=0.07). Favourable outcome (mRS of 0-2 at 90 days) occurred in 30 (57%) patients in the IV-endovascular group and 47 (44%) patients in the IV group (adjusted RR 1.16, 0.85-1.58; p=0.35). The mortality rate at 90 days was 17% in both groups, and symptomatic intracranial haemorrhage was reported in five (9%) patients in the IV-endovascular group and in 12 (11%) patients in the IV group. Better clinical outcome was associated with recanalisation in both groups and with time to recanalisation in the IV-endovascular group.


CONCLUSIONS
An IV-endovascular approach is associated with higher recanalisation rates than is IV alteplase in patients with stroke and confirmed arterial occlusion. In patients treated with an IV-endovascular approach, a shorter time from symptom onset to recanalisation is associated with better clinical outcomes.
Mazighi
Mikael
M
Department of Neurology and Stroke Centre, Bichat University Hospital, Paris, France; Diderot University, Paris, France.
Serfaty
Jean-Michel
JM
Labreuche
Julien
J
Laissy
Jean-Pierre
JP
Meseguer
Elena
E
Lavallée
Philippa C
PC
Cabrejo
Lucie
L
Slaoui
Tarik
T
Guidoux
Céline
C
Lapergue
Bertrand
B
Klein
Isabelle F
IF
Olivot
Jean-Marc
JM
Abboud
Halim
H
Simon
Olivier
O
Niclot
Philippe
P
Nifle
Chantal
C
Touboul
Pierre-Jean
PJ
Raphaeli
Gai
G
Gohin
Christiane
C
Claeys
Elisabeth Schouman
ES
Amarenco
Pierre
P
D000368:Aged; D000369:Aged, 80 and over; D002536:Cerebral Arteries / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D002985:Clinical Protocols; D015331:Cohort Studies; D004333:Drug Administration Routes; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007269:Injections, Intra-Arterial / Q000009:adverse effects / Q000706:statistics & numerical data; D007275:Injections, Intravenous / Q000706:statistics & numerical data; D020767:Intracranial Thrombosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011859:Radiography; D020127:Recovery of Function / Q000187:drug effects / Q000502:physiology; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator