The insights from the DSMB and how data was truncated at 3 yrs for plenary session presentation just before guidelines were written, while DSMB chair called the investigators out on this is baffling
You can argue that this is just different ways of presenting the same data. I disagree. This is suppressing data to control the discussion. Akin to Bill Barr's summary of the Mueller report. Doesn't give the full picture. An informed discussion requires #opendata
The indictment of the guidelines process is damning. @escardio commissioned an external review by expert @brophyj, yet it wasn't shared with all involved and dismissed. This seems akin to the one-line dismissal of #ORBITA trial more recently: indefensible
This illustration puts the main issues at hand ever so clearly. How can we trust data & guidelines from those involved, when they are judge and jury, and stand to profit from all of it?
Two take-home messages from all of this: 1. This is just one trial, for which we have gotten an inside look and come back with huge concerns, from these investigators. @deb_cohen, we need you to look at more trials with the same PI: COAPT, etc.
2. We are learning from this, and working on guidelines we can trust from @escardio and @EACTS. I look forward to collaborating in a true #HearTeam to improve these guidelines and offer the best to our patients!
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Trial design in TAVI
Total number of total primary outcome events 4x lower in low-risk trial for Sapien. CoreValve more robust by design, yet events 2.5x lower and 2yr follow-up computed. #EACTS2020
SYNTAX score is an angiographic score of angiographic complexity
Designed to predict feasibility of PCI - nothing to do with feasibility of CABG or outcomes #EACTS2020
It may prove actually wrong for CABG: a CTO can easily be grafted, yet prediction by SYNTAX would suspect bad outcome. #EACTS2020
After almost 1 year, the wait is over - the #EXCEL investigators finally release the UDMI data in @NEJM nejm.org/doi/full/10.10…
🧵 in a nutshell:
- the EXCEL investigators had the UDMI data, although they said they didn’t
- It shows higher MI risk for PCI
- This is research fraud and the papers should be retracted
@BBCnewsnight have had this data since december, why did it take 7 months more? Gosh @NEJM, what is up?
/2
Main finding: PCI has 2x the incidence of PMI (95%CI: 0.5-3.3), and 4.9x the incidence of all MI when using UDMI (95%CI: 2.6-7.2)