REDUCE LAP-HF I: Interatrial Shunt Device Safe, Patent Out to One Year

A new analysis provides encouraging data for patients with heart failure (HF) with ≥40% ejection fraction requiring an interatrial shunt device.  

Researchers for the 1-to-1 sham-controlled REDUCE LAP-HF I trial enrolled patients with NYHA class III or ambulatory class IV HF and looked at safety assessed by major adverse cardiac, cerebrovascular, or renal events (MACCRE). Additional exploratory outcomes included 10year hospitalization for HF, NYHA class, quality of life, 6-minute walk test, and device patency. 

REDUCE LAP-HF I sham-controlled RCT of InterAtrial Shunt Device (IASD) in #HFpEF demonstrates safety and 100% patency at 12 months, adding to 1 month efficacy results showing lowering of exercise PCWP https://t.co/PM5NUhsdEs

— JAMA Cardiology (@JAMACardio) August 27, 2018

According to the 1-year results, all shunts remained patent in all patients receiving the devices. There were no significant differences in MACCRE between the device arm and the control arm of the study (2 of 21 [9.5%] vs 5 of 22 [22.7%]; P=0.41) with no strokes occurring. No significant differences in yearly hospitalizations for HF, quality of life, and 6-minute walk test were reported between the study groups.  

“The REDUCE LAP-HF I phase 2, sham-controlled randomized clinical trial confirms the longer-term patency of the interatrial shunt devices,” the researchers wrote in the study. “Through 1 year of follow-up, interatrial shunt device treatment appears safe, with no significant differences in MACCRE in patients receiving interatrial shunt devices compared with those who received sham control treatment.” 

Very early and preliminary data, yet intriguing approach to HFpEF. Next phase of trials will be informative. https://t.co/tQAuWvUU7A

— Gregg Fonarow MD (@gcfmd) August 27, 2018

Corvia intra-atrial shunt appears safe in small HFpEF population at 1 year. Underwhelming efficacy suggestion for QoL, 6MW. The Phase 3 efficacy trial will give results in 2024. https://t.co/wvXYFL2cSv

— Mitchell Psotka (@mpsotka) August 27, 2018

https://twitter.com/jeremyprovance/statuses/1034398038679277568

https://twitter.com/knit2/statuses/1034184453244026881

… and more to come with ongoing enrollment in REDUCE LAP-HF TRIAL II. https://t.co/9cSryd0iTf

— Mark J Ricciardi MD (@mj_ricciardi) August 29, 2018

Source: JAMA Cardiology