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)
After a few days to go over the #EXCEL 5 year results published in @NEJM and thinking hard about @DrMoritzWvB tweet on IC and cardiac surgery seeing things quite differently, here are a few thoughts. Glad to hear your thoughts @tssmn@ctsnetorg@EACTS
1/30
2/ Congratulations to the investigators for an outstanding RCT! Important question and results, which will have an impact on guidelines. The protocol was powered for non-inferiority of the composite outcome at 3 years, and congratulations for following these patients to 5 years
3/ why were p-values for secondary outcomes reported selectively? e.g. for revascularization, but not others?