Thread by @jaygirimd

🧵 @InariMedical FLAME trial (largest ever high risk PE study) presented today @ACCinTouch #ACC23 by Mitch Silver!

Details in this thread below

2/ The FLAME trial was 2 parallel prospective registries of high risk PE patients at 11 US hospitals. All patients had hypotension or arrest.

One arm (n=53) included pts treated with Flowtriever large bore embolectomy.

Pts in “context” arm (n=61) treated with other therapies

3/ There were few exclusion criteria so the aim was to enroll a very sick population.

Each arm was compared to historical benchmark of the primary endpoints that was derived through an observational SRMA that was recently published @MyJSCAI :

jscai.org/article/S2772-…

4/ Patients in both arms were very ill. Advanced @SCAI shock class C or worse in about 75% of Flowtriever arm and 90% of context arm.

5/ In the context arm, approx 70% of patients received systemic TPA. This is not surprising as this currently has the strongest guideline recc in this population.

Very few patients in either arm received mechanical circulatory support.

6/ In hospital mortality was as follows:

Flowtriever arm: 2%

Context arm (largely TPA): 30%

Historical benchmark from SRMA above: 29%

Other relevant endpoints are below

7/ Main takeaways:

1) We can do prospective studies of high risk PE patients!

2) Systemic TPA shouldn’t be algorithmically used in this population as a primary txment.

3) PERT teams can select appropriate pts for large bore embolectomy- and this approach has great results!

8/ For more great info on high risk PE, please see recent @AHAScience Statement led by @GoldbergJBCTMD:
ahajournals.org/doi/10.1161/CI…

Also, stay tuned for @PERTConsortium registry data on this population in the fall led by @TaiKobayashiMD

And huge thanks to all the investigative teams involved in FLAME!