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Posts Tagged ‘des in stemi’

DES is  a revolutionary coronary support device ,   but it was always a suspect  when it came to STEMI and primary PCI .

How good and safe is DES in STEMI ?

Cardiologist were always beating around the bush for a specific answer to this question.

The general  principles and background

DES was thought to be unsafe in a thrombotic milieu .(DES was notorious for acute stent thrombosis) .Still ,first generation DES ( Sirolimus and Paclitaxel ) were thought to be unsafe in STEMI .However anecdotal evidence suggested DES reduced stent thrombosis  . .Then came the 2nd generation DES (Zotarolimus and Everolimus ) . There was a  excitement every where .The logic  was   “If first generation of DES is not good . 2nd generation  must be good”   What a way to think scientifically .Wisdom  did not prevail  . Many started using ZOTA /EVERO  in STEMI  .(Medtronic and Abbot were silently enjoying the scenario !)  And now finally Everolimus was tested with BMS in  STEMI .

That is EXAMINATION trial for you  . . . Published in Lancet  September 2012

It  has found  2nd Generation DES are not superior to BMS in STEMI in terms of  patient outcome . The study broadly concluded  that  the patient related parameter did not show any significant difference  while  stent related outcome seemed  fare better.

Why this patient – stent dissociation ?

How can large group of patient who  have more stent thrombosis and TVR ,  still  no correspondingly increased ACS or deaths

Does this mean  these stent thrombosis are safe events ?

The answer lies in the fundamentals. The  stents  represent  anatomical  correction  , while  the patient  outcome depend   more on physiology ( flow )  so we are back to square one  to the fundamental  coronary conflict  ie  improving anatomy need not impact physiology.

Critical comments

After reading the EXAMINATION  trial  I asked my third year fellow .

What was  the re-stenosis rate  in DES vs BMS  at 6 months ?

He said this study never analysed the issue of re-stenosis  .

I asked him , Are you sure ?

He confirmed it with a firm Yes.   And then , I found this

                                   A shocking omission for a study which is supposed to answer a   critical question whether
                                   DES is good for   STEMI in the long term
Final message
What a way to conduct a large  land mark study ?
This  study   never bothered to find out the re-stenosis rate  with DES  after  primary PCI and compare it with BMS  .
In fact they have conveniently mentioned ,  follow up angiogram was not part of the study protocol .
I concluded  at the end of journal  review meet   , that  this  EXAMINATION  was not properly conducted   and DES may come back with a vengeance   in the near future !

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Interventional cardiologist are excessively  talented  guys .They always  lead ahead in innovations  .The only issue is , their  enthusiasm  (   many times  overtake  the pace of science .  In the name of off label indications  they indulge   in drug and device extravaganza   in uncharted territory .

Even as we boast of practicing evidence  based cardiology   scientific  adventures  happen  without  proper  evidence  . . .   rather  we  have wait for evidence to come later .” A clear case of  cart pulling the horse “

The wide-spread of use of  second generation DES in STEMI has not been found to superior to BMS in the  EXAMINATION trial just released in ESC 2011 Paris. It failed miserably ,  when every one took  the superiority  for  granted.( Some may claim  non inferiority is  not a failure , but for a DES which was perceived a revolution,  it is definitely a failure in the  STEMI subset )

Further,  what  EXAMINATION  trial did not  address  is  acute and sub acute  stent thrombosis .Even as the DES is credited  with a dubious  record for  sub acute stent thrombosis ,   there is every reason to  suspect , in  the milieu of STEMI the thrombotic risk of DES  would increase many fold.

The  seemingly  low   incidence  of stent thrombosis with DES  in STEMI ,   in  EXAMINATION  trail  is a statistical mirage .This  trial was  neither  planned  nor powered to address the issue of stent thrombosis.

In the  ultimate  analysis of EXAMINATION ,   One could conclude   Cobalt chromium BMS,  has  cemented  its place ,  more firmly for use in primary PCI.

DES  at best ( *With all those conditions apply , Dual antiplatelet etc) can be equal to BMS,  while  BMS at any  day ,  would  casually will  win over DES without any conditions at a  huge cost advantage.

The above analysis is diagonally opposite to that of general  perception  that  emanated  from Paris  ESC meet 2011   trial   .

Please remember EXAMINATION trial did not reach its desired primary end point  !

That is  a strong point  against it  .What do you think ?

Reference

http://www.theheart.org/article/1272077.do

A  TV  debate on Examination  trial from EURO PCR

http://www.oxfordjournals.org/our_journals/eurheartj/ehjvideo.html

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Drug eluting stents are liberally used  worldover .

It is very unfortunate ,while the jury is still confused about the role of DES  “even”  in chronic coronary syndrome ,

There has been widespread use of DES in  the   potentially hazardous    thrombotic milieu  of STEMI  . It is well known  the DES ( polymer and drug)   has a dangerous liaison  with the thrombus.

Even as the evidence base was about to accumulate against the DES in STEMI , there was  an undue haste in the use of  this stent in STEMI .

Now in 2010 the results are out the DEDICATION trial

  • The culprit is out
  • The truth exposed
  • DES kills more life than bare metal stents   during primary PCI

Read this article  ,just released in Atlanta 2010

http://www.cardiosource.com/clinicaltrials/trial.asp?trialID=1618

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