Thread by @ProfDFrancis

Great question!

https://twitter.com/joeschm80238897/status/1336664563555635206

First, what do you mean by sham?

What does sham mean?

What proportion of patients undergoing elective PCI believe it is for reduction in mortality?

Who told them that?

Zoomed in:

What proportion of patients undergoing elective PCI believe it is for reduction in mortality?

OK now let's think about WHY they think that.

The illuminati and the dental-filling radio-signals can't be to blame. (They are too busy making the earth appear round.)

What is the advice to people who get exertional chest pain?

When your home catches fire, what should you do?

What do the public infer from the advice to contact the Fire Service IMMEDIATELY?

So what do you think people will infer from the advice to see Cardiology services as soon as possible if you develop exertional angina?

If that is the reasonable conclusion patients have drawn from the urgency with which referral to Cardiology is performed, who is the ONLY person that can reverse that conclusion?

If the ONLY person that could reverse that belief, did not do so, is it a suitable defence that,

"We didn't ever SAY that to the patient, it's not our fault!"

Those 90% of people who are going in for elective PCI _believing_ it to be a necessary life-saving procedure, are being

Alan volunteers for a placebo controlled trial of symptom relief. He knows he might get the real drug or the placebo, and understands that neither he nor his treating physician must know which it is until he finishes reporting his symptoms.

Is he a victim of deception?

Bob laughs at Alan. "Don't become a guinea pig, just because it is free! Do what I do, you idiot!"

He sells his house to buy a supply of open-label Francisomycin, "believing it to prevent mortality from chemtrails".

Dr Francis carefully never makes any claims for Francisomycin. He even mutters (and writes in very small print somewhere) that it is not thought to affect mortality.

He just promises peace of mind, for the $400,000 suitcase of tablets.

And he certainly provides that!

Which one has undergone sham treatment?

So no, I am generally not comfortable giving people sham.

I don't approve of the term "sham" to refer to "placebo", just as I don't approve of the term "cyanide" to refer to "water".

I'm funny that way.

You may argue that it is OK, because doctors realise that "cyanide" sometimes is just a term for "water", that we use in the cath lab.

Hmmm... maybe.

Not by me it isn't.

Do you think most doctors realised that "sham" in a procedure is just a very badly misspelled "placebo", rather than some form of dishonesty?

"Also, sham requires active deception by the investigators, violating fundamental patient–physician precepts."

Where did that above sentence come from?

Read and marvel how our profession can squirm and wriggle when faced with proper trial data.

Papers like this show why guidelines should be written by people OUTSIDE the field, because insiders have to diabolical professional conflicts of interest.

sci-hub.se/https://doi.or…

To answer the original question, which was:

And ASSUMING you meant "randomize to placebo", not "randomize to rob patient of $$$",

My answer is, "Depends for how long."

If the apex is indeed normal in function, it is getting ENOUGH blood from RCA or Cx.

(How much is "enough"?

Enough for the function to be normal.)

My answer is "Yes, I would be happy to randomize to placebo, FOR LONG ENOUGH TO ANSWER THE QUESTION."

If that lesion is causing the angina, when should the angina be relieved?

Any reason to keep them randomized for longer than that, in a trial of SYMPTOM relief?

So what do you say to people that objected to ORBITA keeping people randomized for "only" 6 weeks?

Why do you think they complained about the duration of ORBITA being 6 weeks?

Great point!

I used to think that too.

Then one of the ORBITA PhD students, I can't remember who.

(In which case I will say it was my idea)

pointed out this:

Do people ever show up to PPCI with an acute lesion and another chronically blocked vessel, despite no previous cardiac history?

When you see an obvious LAD infarct on ECG, do you completely skip the RCA diagnostic, on the grounds that "well there can't be any SYMPTOMATIC disease of any other vessel, since he had no symptoms until now"?

Because Joe Schmoe's patient might have an RCA like this. Not likely, but perfectly possible.

SOMEHOW it is perfectly possible to have a tight lesion and no symptoms.

That's the fascinating thing about PPCI's: what we see in OTHER vessels.

Sometimes people even show up with 2 chronically severely diseased vessels, and 1 acute vessel, and while we go through them one by one, we are baffled as to how they were pogo-sticking around yesterday feeling normal.

It SHOULD be impossible, but it's not.

It can't be because they are someone who doesn't get pain from their heart: they showed up today, didn't they?

Maybe different parts of the heart need different amounts of blood supply reduction to cause pain?

Of course I would never say that, to avoid upsetting the "FFR 0.80 = angina" fundamentalists.

They get very tense if you even suggest such a thing.

Let's be nice to them for Xmas

EXTENDED QUESTION

Suppose Joe Schmoe's patient had been free of angina.

https://twitter.com/joeschm80238897/status/1336664563555635206?s=20

What would you do then?

I don't believe it. What is the matter with you people?

You SHOULD have been asking this question, instead of answering like half-wits.

'What does "asymptomatic" mean?'

Many critics of ORBITA weren't bright enough to recognise that all 4 of those are plausible meanings of "asymptomatic".

When people are dosed up with 3 anti-anginals, we should bloody well hope that some haven't had any pain IN THE LAST FEW DAYS (i.e. CCS 0)

Most patients clinically undergoing PCI for stable angina have had

So the next time you hear somebody whining that "Loads of ORBITA patients were asymptomatic, so it is all shit, blah blah", they are taking the absence of pain in the LAST FEW DAYS as though it meant "NEVER HAD PAIN".

What should you do?

I hold by my viewpoint (not shared by Rasha) that the most informative result of ORBITA was the experiment carried out on the people who did NOT consent to be randomized, but still volunteered to participate.

The commentators.

Look through the complaints they made. Turn them over in your head.

Use them to judge the analytical skill of the commentator.
You have the advantage that you have the same knowledge that they had, when they commented.

If you find their standard of interpretation is way below yours, that tells you not to take any notice of anything they say about anything, ever.

Yes this is not a very Christmassy sentiment.

But then it doesn't have to be. It is more of a Boxinggy sentiment, which in a way is appropriate to the time of year.

Anyway back to the question, of what I would do if this patient was asymptomatic.

https://twitter.com/joeschm80238897/status/1336664563555635206?s=20

If asymptomatic means "Has had exertional pain over last few months, but none very recently"

Then I would consent them for randomization.

If asymptomatic means "Never had any pain, ever"?

What would you do, then?

Of course I would revascularise!

I am not actually insane!

Look at that vessel! It's not 90%, it's sub-pixel!

If you are not confident that the correct answer is revascularise, let me ask you this:

WHY DID YOU DO THE ANGIOGRAM, you moron?

That angiogram is the most screamingly in need of revasc of any stable coronary artery disease.

If you can't see that, you need your head examined.

My reason to revasc?

"To get more blood into the distal LAD."

Yes, somehow it has enough blood right now to keep the LV function good. And I have no proof that opening it will help the patient.

But I have a strong belief. Otherwise what the hell are we doing in the Cath Lab?

If they are not eligible for the trial, due to being truly asymptomatic, then we use our best clinical judgement, which is (of course) revascularise.

If they ARE eligible for a trial, due to having had symptoms (even if not yesterday/today), then they can contribute to the science of care of FUTURE patients...

NOT by NEVER having a PCI (that would be cruel), but by voluntarily delaying their PCI for some weeks in a placebo controlled trial.

They will get their stent in the end! (We aren't mad!)

Tom explains it well here.

https://twitter.com/DrKeeble/status/1342792247675416576?s=20

So there's the irony.

The commonest reason for not being eligible for ORBITA was that there wasn't a background of angina.

And what happened to them?

They got revascularised of course!

Well, hope you've built yourselves all up to all-gold in the Clinical Trial Interpretation seminars, in readiness for today's seminar?
tweetorials.inspirion.org/h2/3f9dba29d95…