Agree with above comments. The real question is whether frail patients who have yet to have a bleeding complication or fall should continue on anticoagulation or undergo LAA closure.
This new substudy was an interesting idea. And FRAIL-AF was bedevilled by its small size and being underpowered by early termination. But the current much larger study is a post hoc retrospective cohort of the foundational DOAC trials.
So how should one proceed, when faced with somewhat disparate guidance from the results of a small underpowered but prospective RCT, vs results from a study design that ought to only be hypothesis-generating?
I think your conclusion sums it up. To me, there isn’t overwhelmingly high quality evidence to strongly recommend either “staying” or “switching” in the relevant population, so it should really come down to patient values and preferences.
Congrats on the subscribers! As a medical student, I've read a critical analysis of a study on this substack that was subsequently presented at gen med teaching rounds at my institution with a lesser quality of analysis... I'm so grateful for the critically thinking clinicians who post here.
Congrats to you guys for approaching the 100,000 subscriber number. It is well-deserved, and since it’s inception, SM has been the juggernaut of Medical education. 👐
I’m not even a physician (a retired rehab clinician x40yrs), yet I find this Substack extremely valuable, with the comments section often just as useful as the main article. For example, one person responded: “…when various protocols are equivocal in outcomes that patient/family centered risk benefit as a preferred course of actions.” Too often, a physician is too quick to act on his/her treatment bias, completely disregarding the patient/family preference.
Following sensible medicine for almost a year now I really appreciate authors acknowledging that when various protocols are equivocal in outcomes that patient/family centered risk benefit as a preferred course of actions. Also have found this series, now that I’m in my 7Os, a number of topics I never thought much about before (pediatrician) which now do apply and most likely will apply to me personally. It’s a shame one can get CME for some of the posts.
It fulfills the rule "the enemy of good is perfect" ...
You learn very quickly that if you have elderly people that are very stable on a medical regimen- by every clinical marker that is- arbitrary switching them because of a study or a arbitrary notion of what "perfect" is - you will get burned every time..
I have a strong preference for apixiban (Eliquis) in the elderly. Apixiban was approved a year after rivaroxaban and became my preferred DOAC thereafter because of the more sensible dosing (2.5 mg if. 2 of following, >80 years, <60K, creatinine >1.5 mg). In addition, apixiban was superior to warfarin in lowering ischemic stroke with less bleeding risk, whereas rivaroxaban wasn't in the major RCTS (ARISTOTLE and ROCKETAF) establishing their efficacy. Clinicallly, I've seen much more GI bleeding on rivaroxaban (generally not prescribed by me) than apixiban.
Warfarin management is the key to safety with VKA in the frail elderly. I ran a warfarin clinic for a decade and our time in therapeuti crange was much higher than that in the major AFIB trials with a correspondingly lower rate of major bleeding. Conversely, I've seen quite a bit of bad management of warfarin when managed by individual docs based on blood draws.
I've also had patients who obsessively manage their warfarin dosing with at home PT tests who do wonderfully for decades.
Every patient is different and discerning docs take into account how well the warfarin management is for the individual and if not ideal, switching to the best and safest DOAC
We need more clinicians across the board who can critically re-examine their opinions and change them. No applogy, just diving in with an open mind and correcting the assumptions. Thank you for the reminder, Dr. Mandrola.
Agree with above comments. The real question is whether frail patients who have yet to have a bleeding complication or fall should continue on anticoagulation or undergo LAA closure.
This new substudy was an interesting idea. And FRAIL-AF was bedevilled by its small size and being underpowered by early termination. But the current much larger study is a post hoc retrospective cohort of the foundational DOAC trials.
So how should one proceed, when faced with somewhat disparate guidance from the results of a small underpowered but prospective RCT, vs results from a study design that ought to only be hypothesis-generating?
I think your conclusion sums it up. To me, there isn’t overwhelmingly high quality evidence to strongly recommend either “staying” or “switching” in the relevant population, so it should really come down to patient values and preferences.
Amazing article, but who TF named this study LOL
Congrats on the subscribers! As a medical student, I've read a critical analysis of a study on this substack that was subsequently presented at gen med teaching rounds at my institution with a lesser quality of analysis... I'm so grateful for the critically thinking clinicians who post here.
Congrats to you guys for approaching the 100,000 subscriber number. It is well-deserved, and since it’s inception, SM has been the juggernaut of Medical education. 👐
Ben Hourani MD, MBA
I’m not even a physician (a retired rehab clinician x40yrs), yet I find this Substack extremely valuable, with the comments section often just as useful as the main article. For example, one person responded: “…when various protocols are equivocal in outcomes that patient/family centered risk benefit as a preferred course of actions.” Too often, a physician is too quick to act on his/her treatment bias, completely disregarding the patient/family preference.
Following sensible medicine for almost a year now I really appreciate authors acknowledging that when various protocols are equivocal in outcomes that patient/family centered risk benefit as a preferred course of actions. Also have found this series, now that I’m in my 7Os, a number of topics I never thought much about before (pediatrician) which now do apply and most likely will apply to me personally. It’s a shame one can get CME for some of the posts.
It fulfills the rule "the enemy of good is perfect" ...
You learn very quickly that if you have elderly people that are very stable on a medical regimen- by every clinical marker that is- arbitrary switching them because of a study or a arbitrary notion of what "perfect" is - you will get burned every time..
I have a strong preference for apixiban (Eliquis) in the elderly. Apixiban was approved a year after rivaroxaban and became my preferred DOAC thereafter because of the more sensible dosing (2.5 mg if. 2 of following, >80 years, <60K, creatinine >1.5 mg). In addition, apixiban was superior to warfarin in lowering ischemic stroke with less bleeding risk, whereas rivaroxaban wasn't in the major RCTS (ARISTOTLE and ROCKETAF) establishing their efficacy. Clinicallly, I've seen much more GI bleeding on rivaroxaban (generally not prescribed by me) than apixiban.
Warfarin management is the key to safety with VKA in the frail elderly. I ran a warfarin clinic for a decade and our time in therapeuti crange was much higher than that in the major AFIB trials with a correspondingly lower rate of major bleeding. Conversely, I've seen quite a bit of bad management of warfarin when managed by individual docs based on blood draws.
I've also had patients who obsessively manage their warfarin dosing with at home PT tests who do wonderfully for decades.
Every patient is different and discerning docs take into account how well the warfarin management is for the individual and if not ideal, switching to the best and safest DOAC
We need more clinicians across the board who can critically re-examine their opinions and change them. No applogy, just diving in with an open mind and correcting the assumptions. Thank you for the reminder, Dr. Mandrola.