Dr Malik says:
Two trials have come up with absolutely opposite results. Why?
The positive trial , COAPT, had more severe mitral regurgitation and less stretch of the heart.
Mean effective regurgitant orifice area (EROA):
-COAPT 41 mm2
-MITRA-FR 31 mm2
Left ventricular end diastolic volume:
-COAPT 101 mL/m2
-MITRA-FR 135 mL/m
Also, the patients already had maximal medical therapy. But it took a long time to recruit- suggesting that real patients may not be the same as trial patients.
The negative trial, MITRA-FR was a European rather than US lead study, and was clear in showing no benefit.
For the moment let’s wait for RESHAPE-HF2.