2) This is an @cardiomet_CE #JournalClub on "Andexanet alfa versus PCC products for factor Xa inhibitor bleeding: A systematic review with meta-analysis," just pub'd in @PharmacoJournal; @CMichaelWhite2 was lead author. Follow this 🧵for 0.5hr 🆓CE/#CME!#FOAMed @CCPharmacists pic.twitter.com/AWrBFKvRca
— cardio-met (@cardiomet_CE) June 4, 2024
4) So, start by (1) answering these two questions 👇, then (2) check out the subject article at 🔓 https://t.co/dIgeLxMY18, and (3), ONLY HERE, learn from the lead author about the 🔑points to take 🏡.
— cardio-met (@cardiomet_CE) June 4, 2024
5b) In a #metaanalysis that pools low–moderate-risk-of-bias studies together with those at high risk of bias, which of the following endpoints is statistically better with #andexanet vs #PCC?
— cardio-met (@cardiomet_CE) June 4, 2024
a. in-hospital mortality
b. 30d mortality
c. hemostatic efficacy
d. hospital #LOS
7) Pooling studies together increases the power to assess for an underlying significant difference obscured in individual studies. pic.twitter.com/2NYkbWkbsA
— cardio-met (@cardiomet_CE) June 4, 2024
9) This is vital because studies with many #methodological weaknesses can introduce systematic #biases that either accentuate or attenuate the true comparative effects of a therapy. As we will specify later, many of the studies in this literature carry a high risk of bias. pic.twitter.com/AywNwEaEsS
— cardio-met (@cardiomet_CE) June 4, 2024
11a) 18 real world evidence (#RWE) studies were included in our systematic review. A major reason for excluding #andexanet alfa or #PCC studies was because they only reported single arm assessments. pic.twitter.com/XJOjU0RHft
— cardio-met (@cardiomet_CE) June 4, 2024
12a) We used the #MINORS criteria (https://t.co/l5dDLC6i9f) and @JBIEBHC tools (https://t.co/fov0ovkgYE) to assess risk of bias.
— cardio-met (@cardiomet_CE) June 4, 2024
13) A few major weaknesses in the #reversal/#repletion literature were a lack of control of baseline differences between groups, differences in patient inclusion criteria between groups, and a lack of prospective study design. pic.twitter.com/ihu7Zfpuuo
— cardio-met (@cardiomet_CE) June 4, 2024
15) In hospital #mortality was significantly better when #andexanet alfa was used vs #PCC in low-moderate risk of bias studies, but not in high-risk-of-bias studies or the analysis, regardless of study quality. pic.twitter.com/OxRRtiR3nP
— cardio-met (@cardiomet_CE) June 4, 2024
17) #Andexanet_alfa did not increase the risk of #thrombotic events overall or in groups segregated by risk of bias. The 95% confidence intervals for all studies were very long. pic.twitter.com/hMP3fVmlaU
— cardio-met (@cardiomet_CE) June 4, 2024
19) .@CMichaelWhite2: both #ANNEXA_I & our real-world evidence systematic review found significant improvements in #hemostatic efficacy when andexanet is used to reverse, vs #PCC to replete. This ⬆️ confidence that these RCT results also occur under real world conditions. pic.twitter.com/VqyJonPvuJ
— cardio-met (@cardiomet_CE) June 4, 2024
21) #ANNEXA_I was not designed or powered to assess mortality & was stopped early when it met a significant benefit for the primary EP (limiting ability to assess ☠️). In our real-world evidence systematic review, 30d ☠️ was significantly reduced when #andexanet alfa was used.
— cardio-met (@cardiomet_CE) June 4, 2024
23) These #RWE data suggest that any deleterious effects from #thrombotic events do not negate the impact of better #hemostatic efficacy or drive lower 30-day mortality. This supports that andexanet alfa has a positive balance ⚖️ of benefits to harm.
— cardio-met (@cardiomet_CE) June 4, 2024
25) Some literature bases have a lot of available publications, like this one, but the average study’s quality is very poor. This can make it very difficult for frontline #clinicians to reconcile conflicting findings between studies. ⚖️ again!
— cardio-met (@cardiomet_CE) June 4, 2024
27) But hear THIS–you just earned 0.5h CE/#CME! Claim your certificate now at https://t.co/P4UuATqm8E. Thanks to faculty @CMichaelWhite2; join him in FOLLOWING @cardiomet_CE for the BEST in #MedEd delivered wholly on Twitter/X!
— cardio-met (@cardiomet_CE) June 4, 2024