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Posts Tagged ‘stream trial’

Why 3-24h ?

The famous & popular 3-24 hr time window for pharmaco-invasive strategy (PIPCI) was adopted, blindly from STREAM (prehospital Tenecteplase + PCI <6-24h in <3h presenters) and FAST-MI trials  assuming uniform IRA patency. It fails to stress the importance Initial time window to lysis, and its response . This makes the distinction between true rescue vs routine pharmaco invasive PCI  a hazy excercise . Thus, both inappropriately  delayed or a hastily-routine  PCI has become all too common.

The 24-hour upper cutoff in pharmacoinvasive strategy serves to prevent reocclusion, or to address any residual mechanical stenosis . It is not meant for myocardial salvage, which is irrelevant if lysis was successful.

Mind you, IRA optimisation  is not a time bound emergency in a well recannalised vesseel. In fact,  PCI is not an absolute neccesity for long term IRA patency especially if it an coronary erosion. If there is TIMI 3 flow ,and there is  little ischemic substrate , there is no need to chase the , supposedly sacred 24 hr time window. If the lysis achieves complete( or almost complete) IRA patency, PCI can safely  be extended to 48-72 hours, or even permanent deferral (No-PCI , stand alone thrombolysis) in stable patients with optimal medical therapy.

An interesting study is published , from my institute in the current issue of AJC with a title ” Extended Pharmacoinvasive PCI Compared to Primary PCI: Insights From Madras Medical College STEMI Registry” . This study argues for extending the time window for pharmacoinvasive strategy to 48 hrs. (It could still be higher.) It suggests , this flexibility suits the LMIC, due to logistical realities. ( Glad to be listed as a co-athour)

Link to the PDF of the article

I am sure, this study, demands to reset the 24 hr upper limit of cut off for pharmaco invasive strategy.Looking beyond this study, there is an urgent need to clarify the specifc purpose of the generalised time window of “3 to 24” hr time window in pharmaco invasive strategy.

A call for new sub defintions in the time windows in PIPCI

1.Successful Lysis* (TIMI 2-3, in about 70%): Routine angiography/PCI 3-24h (prevent reocclusion/residual stenosis) .Extendable to 48-72h + is possibel. Permanent deferral if the pateint and myocardiumare , with a patent IRA . (Implying no need for further salvage at all , we should allow a green corridor for patients with successful standalone thromolysis to exit the hospital without a PCI ) Doing a PCI onlu t0 prevent fear of reocclusion in the first 30 days is not backed with good data.

2.Failed Lysis* (TIMI 0-1, 30%): Rescue PCI immediately (<3-6h post-lysi, like PPCI) Here the time window should be hastened and can never afford to extend it, at any stretch of imagination.

* Ironically, the 24hr cut of has no place in both the above subsets. (May be in failed lysis , 24 hr cut off might apply , again it is 12 hr longer than primary PCI )

Final message

Time is no longer muscle , if the Intial lysis is successful

What is the purpose of “24-hour” upper limit cut of time in pharmaco invasive strategy ? The 24 hr is not universally valid. Pharmaco Invasive  strategy time windows need to be  based on timing and  efficacy of the Initial  lysis.

Postamble

Commenting this paper as a third person :

One limitation in this study is to be admitted. I think, the generalised comparative efficacy of extended PIPCI with primary PCI can not be made, for the simple reason, the extension of time window is possible only in patients who had successful lysis. This study may ideally be concluded as  “3-24h pharmacoinvasive PCI can be extended to 48h if the initial lysis successful” . Further, If initial lysis fails (30% TIMI 0-1), any extension is contraindicated and requires immediate rescue PCI akin to PPCI. Also, data regarding non-IRA intervention might help understand the importance of the extension of the time window better.

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How can we use AI as a tool of knowledge distillation ?

Here is a deep discussion with Grok 3, on the merits, limitations & validity of DANAMI 2 and PRAGUE 2 , the two old studies on pPCI. Curiously , we don’t have any other studies to quote. As on 2025 , superiority of pPCI hangs precariously on these two decade old studies, which has some serious omissions in the primary end point and its Interpretation. To get into the facts , please go through the following link.

https://grok.com/Is primary PCI really superior to lysis in a global perspective /

It is a long chat, I am sure most of you can’t spare your vital time. But, the truth comes out only at the fag end of the conversation.

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Primary PCI (pPCI) is a  glorious revascularization strategy for STEMI practiced for over 2 decades  but still has not proved its perceived mettle convincingly as a large population based strategy. In the mean time, the utility value  of  thrombolysis  was systematically  (Intentionally too! )  downgraded in the minds of both academic and public mind.
Truth can’t be buried for long. Series of revelations are coming up restoring the superiority of early thrombolysis over pPCI even in PCI capable centers.
In 2013, the high Impact STREAM trial argued  for pharmacoinvasive approach within 3 hrs as it was at equipoise with a pPCI. Now, EARLY -MYO  from China vouch  for pharmaco- Invasive approach  till 6 hours. (Just published in Circulation September 2017 )
 
 I think we need to wait for some more time , for another prevailing  falsehood that need to be busted ,(Looking  out for some straight thinking new generation cardiologist to do it !)
What is that ?
Many of us have misunderstood(rather made to !)  that pharmaco Invasive has a defined therapeutic endpoint ie taming  & stenting the IRA . This is absolute ignorance  happening even in state of the art centres ,ironically this beleaguered concept is  backed by peer-reviewed papers from premier journals. The fact of the matter is , If thrombolysis is stunningly successful (Which at the least happens in 50 % ) one can stop with that , it’s also a therapeutic endpoint at least for time being .
Is coronary angiogram a baseline test like ECG ?
That’s what current cardiologists with cutting edge knowledge  seem to believe !  Do you agree ! I am sure I’m not !
 Patients with STEMI who had successful thrombolysis who had an  apparently uncomplicated course (Assessed by strict clinical ECG, ECHO criteria) need not go for coronary angiogram in the immediate future.In fact some good guidelines strongly argue for it and call it as Ischemia driven PCI ! but very few seem to respect that concept.)This will not only contain the cost and ensure the vast majority of Inappropriate (  scientific quackery) coronary plumping activity in human race.
Searching for an elusive data ! Can some one help ?
I have been searching for data , from all those major pharmaco invasive studies (Which is not being reported /shared or analysed )
How many  patients in the “success cohort” after thrombolysis  who subsequently land up with urgent PCI related complications when trying to stent an already reperfused IRA or while tackling  coexisting Innocent or non-innocent non IRA lesions ?
* Complications and adverse events  may be acceptable in patients who had failed thrombolysis or who are  unstable  but even minor adverse events are forbidden in patient with a truly successful and asymptomatic patient.
Final message
So called scientific facts have very short half life !  for the simple reason they are let loose in human domain prematurely !
Reference 

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