The "faith healing and subtraction anxiety" framing is brillant—it perfectly captures how unblinding creates psychological pressure that drives the endpoint. The divergance between objective (ECG/enzymes) and subjective (symptoms) triggers for urgent revasc in the medical arm is stunning. Its a textbook example of why you can't just assume away the placebo effect in cardiovascular interventions. The fact that FFR gained widespead adoption based on this flawed methodology is both depressing and unsurprising.
The neglect of psychological realities (placebo effects, emotional state, pleasing one's physician) has been a massive cause of wasted resources in healthcare.
Very helpful analysis. I am not sure I agree with the premise that "avoiding an urgent revascularization is a positive..." The premise of the trial rests on the idea that an "urgent" percutaneous coronary intervention (PCI) is dramatically different that an "elective" PCU. In the first place, as you show, most of the "urgent" PCIs in the medical therapy arm were driven by subjective symptoms rather than any objective evidence of clinical harm. In the FAME-2 trial, then, the authors are proposing that doing elective PCI in 100% of patients with FFR<0.80 is clinical valuable because it prevents doing "urgent" PCI in 15% of them otherwise (the difference in "urgent" PCI between intervention [10%] and medical therapy [25%] arms. If one ignores the distinction between "elective" and "urgent" PCI, the proposition is absurd.
The fallacy here I believe is classifying a medical intervention as a "therapy" in one arm and an "adverse event" in the other arm. This methodology plainly stacks the deck in favor of the intervention. They made the same error in the EARLY AS trial.
Can you image if EPs did a trial of catheter ablation for asymptomatic AF and randomized half to ablation and half to medical therapy and then considered ablation for symptomatic AF in follow-up to be an endpoint? Of course catheter ablation would "win." I think we would all recognize this thinking as fallacious.
..."one group got fixed; one group got tablets."...and in the end, not one person was healed because whatever is causing the stenosis or blockages will never be addressed. The root causes of these problems are ignored by doctors and that is a crime. Then again, it is because they have no clue.
Crix is really good at engaging in the comment section and explaining his comments, but if he doesn’t respond in a day or so, I’ll jump in with the older, mainstream (ACC/AHA) theory of what causes stenosis vs. more recent evidence of its cause.
“Then one gets fixed and feels fixed, and the other group gets meds and feels unfixed.” Love this phrase.
The "faith healing and subtraction anxiety" framing is brillant—it perfectly captures how unblinding creates psychological pressure that drives the endpoint. The divergance between objective (ECG/enzymes) and subjective (symptoms) triggers for urgent revasc in the medical arm is stunning. Its a textbook example of why you can't just assume away the placebo effect in cardiovascular interventions. The fact that FFR gained widespead adoption based on this flawed methodology is both depressing and unsurprising.
The neglect of psychological realities (placebo effects, emotional state, pleasing one's physician) has been a massive cause of wasted resources in healthcare.
Very helpful analysis. I am not sure I agree with the premise that "avoiding an urgent revascularization is a positive..." The premise of the trial rests on the idea that an "urgent" percutaneous coronary intervention (PCI) is dramatically different that an "elective" PCU. In the first place, as you show, most of the "urgent" PCIs in the medical therapy arm were driven by subjective symptoms rather than any objective evidence of clinical harm. In the FAME-2 trial, then, the authors are proposing that doing elective PCI in 100% of patients with FFR<0.80 is clinical valuable because it prevents doing "urgent" PCI in 15% of them otherwise (the difference in "urgent" PCI between intervention [10%] and medical therapy [25%] arms. If one ignores the distinction between "elective" and "urgent" PCI, the proposition is absurd.
The fallacy here I believe is classifying a medical intervention as a "therapy" in one arm and an "adverse event" in the other arm. This methodology plainly stacks the deck in favor of the intervention. They made the same error in the EARLY AS trial.
Can you image if EPs did a trial of catheter ablation for asymptomatic AF and randomized half to ablation and half to medical therapy and then considered ablation for symptomatic AF in follow-up to be an endpoint? Of course catheter ablation would "win." I think we would all recognize this thinking as fallacious.
So, how the heck do you decide to jump in with the PCI?
..."one group got fixed; one group got tablets."...and in the end, not one person was healed because whatever is causing the stenosis or blockages will never be addressed. The root causes of these problems are ignored by doctors and that is a crime. Then again, it is because they have no clue.
I’m not sure what you mean. Could you be more specific?
Crix is really good at engaging in the comment section and explaining his comments, but if he doesn’t respond in a day or so, I’ll jump in with the older, mainstream (ACC/AHA) theory of what causes stenosis vs. more recent evidence of its cause.