MR CLEAN Journal Primer Donaldson

A  Randomized  Trial  of  Intraarterial  Treatment  for  Acute  Ischemic  Stroke  (MR  CLEAN  Trial)  

SIR  RFS  Journal  Primer  

BOTTOM  LINE  •  In  patients  with  acute   ischemic   stroke   from  proximal   intracranial   occlusion  of   arterial   circulation,  

intraarterial   treatment   (IAT)  within   6   hours   of   stroke   onset  was   safe   and   effective,   leading   to   an  increase  in  functional  recovery  without  greater  mortality.  .      

 MAJOR  POINTS    •  As   a   contrast   to   recent   trials  which   showed  no  beneFit   to   IAT,   this   study   showed   a   clear,   patient-­‐

centered  outcome  of  improved  functional  status  as  a  result  of  if  IAT.    •  NIH  Stroke  Scale  after  5-­‐7  days  2.9  points  lower  in  the  intervention  group  than  the  control  group.    •  No  signiFicant  between  group  difference  in  mortality  or  other  severe  adverse  events  during  the  90  

day  follow  up.    

CRITICISM    

•  Unbalanced  randomization,  with  more  patients  in  the  control  group  than  the  intervention  group.  Addressed  by  stratiFication.    

•  Lower  reperfusion  rate  than  recent  case  series.  May  have  resulted  from  heterogeneity  of  outcome  measures.    

•  9%  of  patients  in  the  intervention  group  experienced  embolization  to  new  vascular  territories.    

•  Patients  aware  of  their  treatment  group  assignments.          

Quick  Summary  

RANDOMIZED  CONTROL  TRIAL  •  500  patients  at  16  medical  centers  in  the  Netherlands  with  proximal  arterial  

occlusion  in  the  anterior  cerebral  circulation  that  was  conFirmed  on  vessel  imaging  and  that  could  be  treated  intraarterially  within  6  hours  after  symptom  onset,  from  December  2010  to  May  2014.    

INCLUSION  CRITERIA  •  Patients  18  years  of  age  or  older.    •  Occlusion  of  the  distal  intracranial  carotid  artery,  middle  cerebral  artery  (M1  or  

M2),  or  anterior  cerebral  artery  (A1  or  A2).    •  VeriFied  by  CT,  CTA,  MRA,  or  DSA.      EXCLUSION  CRITERIA  •  Cerebral  infarction  in  distribution  of  the  relevant  occluded  artery  in  the  

previous  6  weeks.    •  Arterial  blood  pressure  >185/110.  •  Blood  glucose  <2.7  or  >22.2  mmol/L.          

Study  design  

•  In  patients  with  acute  ischemic  stroke  from  proximal  intracranial  arterial  occlusion,  intraarterial  treatment  will  effectively  revascularize  these  territories.  Prior  to  this  study,  however,  there  has  not  been  a  demonstration  of  a  functional  beneFit  to  the  patient  from  this  revascularization.      

Purpose  

•  Actual  intraarterial  therapy  (with  or  without  mechanical  thrombectomy)  was  performed  in  196  of  233  patients  in  the  intervention  group  (84.1%).  Mechanical  treatment  was  performed  in  195  of  the  233  patients  (83.7).  

Interven7on  

Outcome    

•  Shift  in  the  distribution  of  primary  outcome  scores  in  favor  of  the  intervention,  consistent  across  all  categories  of  the  modiFied  Rankin  scale,  except  for  death.        

Credits  

SUMMARY  BY:    Jeffrey  Barrett  Donaldson,  M.S.,  MS4  College  of  Medicine  SUNY  Upstate  Medical  University    FULL  CITATION:  Berkhemer,  Olvert  A.,  et  al.  "A  randomized  trial  of  intraarterial  treatment  for  acute  ischemic  stroke."  New  England  Journal  of  Medicine  372.1  (2015):  11-­‐20.  Fransen,  Puck  SS,  et  al.  "MR  CLEAN,  a  mul7center  randomized  clinical  trial  of  endovascular  treatment  for  acute  ischemic  stroke  in  the  Netherlands:  study  protocol  for  a  randomized  controlled  trial."  Trials  15.1  (2014):  343.          

Society  of  Interven7onal  Radiology  3975  Fair  Ridge  Drive    |    Suite  400  North    Fairfax,  VA  22033  (703)  460-­‐5583    

sirweb.org