Right on with every point. Quality metrics should be completely abandoned for all the reasons given. In addition, can you imagine all the various interests that would have a large financial and/or reputational stake in establishing and maintaining their favored "metrics".
Does even one cardio guy address the problems that create negative heart conditions in the first place? This is why no matter how many "improvements" come along, cardiology will still be a stone age medical endeavor. More tests, procedures and drugs do not change anything. Except increase the income, revenues and profits. The root causes of heart failures are ignored and this insures a steady lineup of patients into the foreseeable future. No thanks.
The titration off BB is very interesting aspect. How did it pass IRB? Or was there really equipoise? It's a pretty bold move to titrate off of BB if that is standard of care.
It's the kind of gimmick that arguable is often to used to promote a new drug by making control group less than SoC. Although here if there is bias toward less is more minimalism we may wink so long as it turns out ok, which is problematic.
VP notes the conundrum but it raises important ethical questions of how to ethically show less is more after the horse is out of the barn.
Certainly, when trialing “new” therapies, they have to be tested against proper contemporary SOC or on top of such SOC, so that we know the “new” thing actually adds something. VP has spoken multiple times in the past about “new” cancer therapies that have been trialed against subpar controls. That’s clearly wrong.
But I think it’s valid to periodically revisit that SOC when not testing “new” therapies. Post MI, we were routinely discharging pts on 5 drugs just for that diagnosis. Pill burden and polypharmacy become legit concerns, esp for pts with multiple diagnoses. If we can show that some older pillars are no longer necessary in the midst of combinations with newer agents, that to me is still useful and clinically actionable information.
In that context, I feel this study meets the bar. It’s testing BB in the same way a “new” drug should be tested…against background of SOC (in this case, everything in real-life SOC minus the BB), trying to show superiority. It’s testing BB in the same way any new medical therapy for post MI care would and should be tested.
Dr. Mandrola in his Medscape post today reviewing this study lists 3 other upcoming BB post MI trials. So there will be opportunities for these results to be replicated (or not).
I think when I’m on CCU in 2 weeks, based on this study and the fact modern pts look nothing like those from the BB post MI trials of yore, I’m putting this evidence into practice.
However, I will soon see pts in follow up who I discharged while on CCU a month ago (when I still sent such pts home on BB). So that will be the evidence free zone….as you say, should you discontinue pts whom you’ve already started? (unlike this trial which speaks to the decision of whether to start at all). I don’t think there is anything on point. But my inclination will likely be to extrapolate this data after a discussion with the pt about what we now know and what remains unknown.
Right on with every point. Quality metrics should be completely abandoned for all the reasons given. In addition, can you imagine all the various interests that would have a large financial and/or reputational stake in establishing and maintaining their favored "metrics".
His comments on quality metrics needs to be shouted from the rooftops... especially since they are antithetical to true shared decision making
Does even one cardio guy address the problems that create negative heart conditions in the first place? This is why no matter how many "improvements" come along, cardiology will still be a stone age medical endeavor. More tests, procedures and drugs do not change anything. Except increase the income, revenues and profits. The root causes of heart failures are ignored and this insures a steady lineup of patients into the foreseeable future. No thanks.
The titration off BB is very interesting aspect. How did it pass IRB? Or was there really equipoise? It's a pretty bold move to titrate off of BB if that is standard of care.
It's the kind of gimmick that arguable is often to used to promote a new drug by making control group less than SoC. Although here if there is bias toward less is more minimalism we may wink so long as it turns out ok, which is problematic.
VP notes the conundrum but it raises important ethical questions of how to ethically show less is more after the horse is out of the barn.
I agree it’s not a straightforward question.
Certainly, when trialing “new” therapies, they have to be tested against proper contemporary SOC or on top of such SOC, so that we know the “new” thing actually adds something. VP has spoken multiple times in the past about “new” cancer therapies that have been trialed against subpar controls. That’s clearly wrong.
But I think it’s valid to periodically revisit that SOC when not testing “new” therapies. Post MI, we were routinely discharging pts on 5 drugs just for that diagnosis. Pill burden and polypharmacy become legit concerns, esp for pts with multiple diagnoses. If we can show that some older pillars are no longer necessary in the midst of combinations with newer agents, that to me is still useful and clinically actionable information.
In that context, I feel this study meets the bar. It’s testing BB in the same way a “new” drug should be tested…against background of SOC (in this case, everything in real-life SOC minus the BB), trying to show superiority. It’s testing BB in the same way any new medical therapy for post MI care would and should be tested.
I agree tricky.
Titration off though is not exactly the same as testing A or not A. It itself is new purpose intervention.
A. no BB
B. BB
C. titration off preexisting use of BB
Probably should have
D. sham titration off BB
This could create a powering question.
Then there is ethics. Are BB really current standard of care? 🤷♂️
The important thing is to always try to be both ethical and scientific. This requires thoughtful consideration.
Ongoing randomization is probably good solution. But would MDs agree for themselves and family members to that. A lot of ego involved.
Physicians have to lead by example by agreeing to have there own treatment subject to randomization when sold basis.
Dr. Mandrola in his Medscape post today reviewing this study lists 3 other upcoming BB post MI trials. So there will be opportunities for these results to be replicated (or not).
I think when I’m on CCU in 2 weeks, based on this study and the fact modern pts look nothing like those from the BB post MI trials of yore, I’m putting this evidence into practice.
However, I will soon see pts in follow up who I discharged while on CCU a month ago (when I still sent such pts home on BB). So that will be the evidence free zone….as you say, should you discontinue pts whom you’ve already started? (unlike this trial which speaks to the decision of whether to start at all). I don’t think there is anything on point. But my inclination will likely be to extrapolate this data after a discussion with the pt about what we now know and what remains unknown.