MATTERHORN trial finds TEER non-inferior to surgical procedure for secondary mitral regurgitation

There was no distinction in efficacy between transcatheter edge-to-edge restore (TEER) and surgical procedure in sufferers with secondary mitral regurgitation (MR), in keeping with late-breaking analysis offered in a Scorching Line session as we speak at ESC Congress 2024.

“TEER is often used to deal with sufferers with secondary MR, however there was no randomized trial evaluating it with conventional surgical procedure. Within the MATTERHORN trial, we had been in a position to present non-inferiority between the 2 strategies for bettering MR – each strategies labored properly – with some security advantages favoring TEER,” stated examine presenter Professor Volker Rudolph of the Coronary heart and Diabetes Middle NRW, Dangerous Oeynhausen, Germany

This investigator-initiated randomized managed trial recruited sufferers with secondary MR, left ventricular ejection fraction (LVEF) ≥20%, with signs of coronary heart failure (New York Coronary heart Affiliation [NYHA] class ≥2) regardless of optimum guideline-directed medical remedy, who had been thought-about at excessive surgical danger by the native Coronary heart Group. Sufferers had been randomized 1:1 to mitral TEER or surgical mitral valve remedy (mitral valve restore or substitute on the surgeon’s discretion).

The first efficacy endpoint was the composite of demise, hospitalization for coronary heart failure, mitral reintervention, help machine implantation and stroke at 1 12 months. The important thing secondary endpoint was the recurrence of MR grade ≥3 at 1 12 months. The first composite security endpoint, assessed at 30 days, included demise, myocardial infarction, main bleeding, stroke or transient ischaemic assault, rehospitalization, all reinterventions, non-elective cardiovascular surgical procedure, renal failure, deep wound an infection, mechanical air flow >48 hours, gastrointestinal issues requiring surgical procedure, new-onset atrial fibrillation (AF), septicemia and endocarditis.

In complete, 210 sufferers had been randomized from 16 facilities in Germany. The typical age was 70.5 years and 40% had been feminine. The imply LVEF was 43% and coronary heart failure was NYHA class III or IV in 86% of sufferers. The median European System for Cardiac Operative Threat Analysis (EuroSCORE) II rating was 3%. Within the surgical group, 72% underwent mitral valve restore and 28% underwent mitral valve substitute.

There was no vital distinction within the major composite endpoint, which occurred in 16.7% of sufferers within the TEER group and 22.5% within the surgical group at 1 12 months (odds ratio [OR] 0.69; 95% confidence interval [CI] 0.33-1.44; p=0.320), with non-inferiority confirmed (p<0.01 for non-inferiority).

There was no vital distinction within the recurrence of MR grade ≥3 at 1 12 months: 8.9% of sufferers within the TEER group vs. 1.5% within the surgical group (OR 6.22; 95% CI 0.75- 51.95; p=0.091). After 1 12 months, 73.2% of sufferers within the TEER group and 87.3% of sufferers within the surgical group had MR grade ≤1, highlighting the efficacy of each therapies.

The first security endpoint occurred in considerably extra sufferers within the surgical group (54.8%) than within the TEER group (14.9%; p<0.001), which was largely pushed by extra main bleeding (29% vs. 3%, respectively), all reinterventions (19% vs. 8%) and new-onset AF (33% vs. 9%).

The MATTERHORN trial is the primary randomized trial to show the non-inferiority of TEER and surgical procedure in sufferers with secondary MR. These new information might grow to be essential to information choice making as European guidelines2 presently advocate TEER could also be thought-about in sufferers who’re judged inoperable or at excessive surgical danger by the Coronary heart Group.”

Stephan Baldus, Principal Investigator, Professor from the College of Cologne, Germany