Systemic  review  of  treatment  of  intermi1ent  claudica5on  in  the  lower  extremi5es  

RFS  Journal  Primer  

BOTTOM  LINE  •  Given  the  limited  research,  supervised  exercise  therapy,  endovascular  therapy,  and  open  surgery  are  

superior  to  medical  management  in  terms  of  walking  distance,  pain,  and  claudication.    •  Blood  Alow  parameters  (ABI)  improved  faster  and  better  with  both  forms  of  revascularization,  which  

may  not  necessarily  correlated  with  clinical  improvement.      MAJOR  POINTS    •  High  quality  evidence  from  2  Cochrane  systematic  trials  favoring  supervised  exercise  therapy  (SET)  

for  improved  walking  performance  •  High  quality  evidence  favoring  revascularization  as  compared  to  optimal  medical  therapy  (OMT)  for  

improved  walking  performance  and  blood  Alow  parameters  •  Low   quality   evidence   showing   better/faster   improvement   in   ABI  with   revascularization   (open   or  

PTA)  as  compared  to  SET  •  Moderate  evidence  showing  increase  in  30-­‐day  morbidity  and  mortality,  longer  length  of  stay,  higher  

complication  rate,  but  increase  in  durability  and  patency  in  open  surgery  compared  to  PTA  •  Limited  studies  demonstrating  higher  mean  cost  of  PTA  compared  to  SET  

CRITICISM    

•  Limited  number  of  trials  and  systematic  reviews  from  which  to  draw  conclusions  

Quick  Summary  

Meta-­‐analysis  of  multiple  RCTs  and  systematic  reviews  •  A  total  of  1548  patients  in  a  total  of  12  trials.    •  A  total  of  8  systematic  reviews  were  evaluated  (3  Cochrane  reviews  on  exercise  

therapy,  2  on  SET  with  endovascular  therapy,  and  3  of  nonrandomized  surgical  case  series)  

•  The  median  length  of  follow-­‐up  was  15  months  

INCLUSION  CRITERIA  •  Randomized  trials  or  systematic  reviews  •  Enrolled  patients  with  claudication  (ie,  symptomatic  patients  with  peripheral  

vascular  disease  who  had  exertional  pain  with  walking)  •  Evaluated  open  bypass,  endovascular  revascularization,  or  exercise  therapy  •  Measured  the  outcomes  of  interest  

EXCLUSION  CRITERIA  •  Duplicates,  no  original  data,  or  ab  irrelevant  population  (ie:  patients  with  CLI)    

Study  design  

•  To  evaluate  the  available  modalities  currently  in  practice  to  treat  patients  with  claudication  with  respect  to  their  efAicacy.  

Purpose  

•  RCTs  and  systematic  reviews  comparing  medical  management,  supervised  exercise  therapy  (SET),  endovascular  treatment,  and  open  bypass  

•  Metrics  evaluated  were  •  Mortality/morbidity  

•  Amputation  

•  QOL  

•  Walking  distance  

•  ABI  

•  Patency  

•  Cost  

Interven7on  

Outcome    

•  Exercise  therapy  •  2  systematic  reviews,  a  total  of  2818  patients  from  44  RCTs  

•  Outcomes  •  Exercise  signiAicantly  improved  maximal  walking  distance  and  time  compared  with  usual  care  or  

placebo  (including  pentoxifylline,  iloprost,  antiplatelet  agents  and  vitamin  E,  or  pneumatic  calf  compression).  Improvements  persisted  over  2  years.    

•  Supervised  therapy  translated  to  an  increase  in  walking  distance  of  180  meters  as  compared  to  non-­‐supervised  therapy  

•  Comparing  endovascular  therapy  with  medical  management  •  MIMIC  trial:  PTA  vs  no  PTA  in  patients  already  in  SET  programs,  follow  up  for  24  

months  •  PTA  group  had  higher  adjusted  walking  distance  and  ABI,  but  not  QOL  

•  Creasy  et  al,  1990:  PTA  vs  SET,  follow-­‐up  9-­‐10  months  •  SET  lead  to  better  mean  claudicating  distance.    PTA  had  initial  improvement  for  3  months  

without  subsequent  improvement.    SET  continued  to  improved  over  15  months.  

•  Nylaende  et  al,  2007:  PTA  +  medical  therapy  vs  medical  therapy.  2  year  follow  up  •  Early  management  with  PTA  and  medical  therapy  better  than  medical  therapy  alone  with  regards  

to  pain  free  walking  distance  ,  pain,  and  QOL.  Greatest  difference  at  3  months.  No  difference  at  2  years.  

 

Outcome    

•  Comparing  endovascular  therapy  with  medical  management  (cont)  •  Hobbs  et  al,  2006:  PTA  superior  to  SET  and  best  medical  treatment  on  basis  of  ABI,  

initial  claudication  distance,  and  absolute  claudication  distance  at  6  months  

•  Perkins  et  al,  1996.  Early  improvement  with  SET,  but  no  difference  at  long  term  follow  up.  PTA  increased  ABI.  

•  Spronk,  et  al,  2009.  No  difference  between  endovascular  therapy  and  SET  with  respect  to  pain-­‐free  walking  distance  at  6  and  12  months,  and  7  year  follow-­‐up.  Somewhat  faster  improvement  with  PTA.  

•  Whyman,  et  al,  1997.    Adding  PTA  to  medical  therapy  (aspirin,  smoking  cessation,  and  exercise)  did  not  result  in  signiAicant  difference  in  walking,  onset  of  claudication,  walking  distance,  or  ABI.  

•  CLEVER  trial.  Longer  peak  walking  time  at  6  months  in  the  SET  arm  compared  with  optimal  medical  therapy  (OMT)  and  stenting.  ABI  improved  in  the  stenting  group.  •  After  6  months,  stent  revascularization  had  better  patient  reported  QOL  as  compared  with  SET  

and  OMT  •  ABI  improved  in  the  stenting  group  

•  ERASE  trial.  Endovascular  therapy  +  SET  resulted  in  signiAicant  greater  improvement  in  pain-­‐free  and  maximum  walking  disease  and  health-­‐related  QOL  compared  to  SET  alone  

•  2  separate  systematic  reviews  (Frans  et  al  and  Ahimastos  et  al)  concluded  that  endovascular  therapy  and  SET  are  likely  equal  •  Combination  of  both  is  likely  better  than  1  approach  alone  

 

Outcome    

•  Comparing  endovascular  therapy  with  surgery  •  Van  der  Zaag  et  al,  2004:  Bypass  had  higher  clinical  improvement  in  Rutherford  

classiAication  than  PTA    •  Bypass  had  higher  1  year  patency  and  less  incidence  of  reocclusion  

•  Wolf  et  al,  1993.    Both  had  improvement  in  functional  status  

•  A  systematic  review  (which  also  included  CLI  patients)  with  a  total  of  5358  patients  showed  that  bypass  was  associated  with  longer  hospital  stay,  higher  complication  rate,  and  30-­‐day  mortality.  Bypass  had  higher  patency  and  durability.  2nd  review  showed  increased  30-­‐day  morbidity,  but  no  difference  in  mortality.    

•  Comparing  any  revascularization  with  medical  management  or  exercise  •  Gelin  et  al,  2001.  Invasive  vascularization  increases  walking  capacity  and  was  more  

effective  than  supervised  training  in  alleviating  illness  speciAic  symptoms  compared  to  medical  management  or  exercise  

•  Nordanstig  et  al,  2014.    Invasive  vascularization  is  associated  with  improved  QOL  and  higher  initial  claudication  distance,  but  not  maximum  walking  distance  

 

Outcome    

•  Cost  utilization  data.  Very  limited  data  due  to  most  RCTs  that  included  cost  analysis  also  included  CLI  •  Spronk  et  al,  2008.    Higher  cumulative  cost  per  patient  for  endovascular  therapy  

compared  to  a  hospital-­‐based  exercise  program,  despite  similar  outcomes  at  12-­‐months  

•  Bermingham  et  al,  2013.  SET  more  cost  effective  than  unsupervised  therapy  

•  Mazari  et  al,  2013.  SET  with  PTA  is  more  cost  effective  than  PTA  alone  

   

Outcome    

   

Credits  

SUMMARY  BY:    Alexander  Lam  M.D.,  R1  PGY2  Department  of  Radiological  Sciences  University  of  California,  Irvine  Medical  Center    Malgor  RD,  Alalahdab  F,  Elraiyah  TA,  et  al.  A  systematic  review  of  treatment  of  intermittent  claudication  in  the  lower  extremities.  Journal  of  vascular  surgery.  2015;61(3  Suppl):54S-­‐73S.  

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