English to Russian Medical Medical (general)

«Are NOACs as effective as C/L? »
In major orthopedic surgery, results among NOACs are heterogeneous in terms of absolute asymptomatic VTE incidence and relative difference of risk with C/L. The only consistent finding among all studies is the lack of demonstration of benefit on symptomatic VTE and PE. For the absolute risk, in the same TKR indication, the total asymptomatic VTE rate varied markedly, ranging from 9 % to almost 40% without correlation with the PE rate. This confirms that venography results cannot be extrapolated to real life setting because of this lack of correlation. Same heterogeneity was found in terms of comparative risk difference with C/L.

(If more explanation required for “heterogeneity”vs C/L)
Two trials failed their objectives (REMOBILIZE with dabigatran and ADVANCE I with apixaban) and C/L superiority was even demonstrated in REMOBILIZE, 2 others demonstrated non-inferiority but using inappropriate margin of Non Inferiority (REMODEL and RENOVATE with dabigatran), 3 trials showed superiority but with an increase in bleeding events (RECORD-1, 3, 4 with rivaroxaban), 1 was biased by treatment duration (RECORD-2 with rivaroxaban), and finally only one demonstrated superiority without increase in bleeding (ADVANCE-2 with apixaban but had numerically higher PE rate. There are clearly heterogeneous results. These results depend on the drug, the type of surgery and the dose used.

As of today more than 200 million patients have been treated with C/L in real life setting, which gives you/us a great experience and confidence in the drug
However, NOACs might become a good alternative to VKA treatment in chronic indication such in patients with atrial fibrillation (AF) because of a clear unmet medical need in this field- which is not the case in orthopedic surgery where the risk is covered and therapeutic options are numerous. As you know, dabigatran was recently approved in the US for the prevention of stroke in patients with AF whereas the application of rivaroxaban in orthopedic surgery is still pending despite an earlier filing of the dossier. This illustrates which priorities were given by the FDA in terms of indication.