According to reports in TCTMD, analysis presented by Abbott last week from its EXPAND registry compares favorably with outcomes seen in the landmark COAPT trial back in 2018. EXPAND was conducted across 57 locations in the U.S. and Europe.
Abbott Park, Ill.-based Abbott’s MitraClip, a transcatheter mitral valve repair (TMVR) system, is a non-surgical option for treating mitral regurgitation (MR) or a leaky heart valve. MitraClip is delivered to the heart through a vein in the leg and clips portions of the leaflets or flaps of the mitral valve together to reduce the backflow of blood.
MitraClip’s latest version received CE Mark approval in September, having already received FDA clearance back in July 2019. The device then won the 2020 Prix Galien USA Award for Best Medical Technology in October, highlighting its status in the replacement heart valve space.
The mortality rate for secondary MR patients treated with MitraClip NTR or XTR was 17.7%, coming in 1.4% lower than the 19.1% mortality rate posted at 12 months in COAPT. EXPAND’s rate of hospitalization for heart failure was 26%, which was slightly higher than the rate observed in COAPT.
“COAPT is a very nice and important clinical trial, but the patient population was highly selected,” lead investigator Dr. Jörg Hausleiter (Ludwig-Maximilians-Universität, München, Germany) told TCTMD. “In EXPAND, this was a real-world study, and we included patients as we see them today where we think the MitraClip is going to be beneficial. There aren’t the same constraints as we have in a randomized trial in terms of inclusion/exclusion criteria. This is real-world, representing daily practice.”