Antithrombotic strategies after transcatheter edge-to-edge repair: clinical implications from the MitraSafe study.

BACKGROUND: The correct antithrombotic strategy after the MitraClip system needs to be clarified.

OBJECTIVES: This study aimed to compare the clinical outcomes of single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) following transcatheter edge-to-edge repair (TEER) using the MitraClip system. The objective was to evaluate their relative safety and efficacy in a real-world cohort, offering preliminary evidence to inform future prospective studies.

METHODS: The study retrospectively analysed patients who underwent MitraClip implantation at a high-volume tertiary care centre in Rome, Italy. Patients treated with oral anticoagulant therapy (OAC) were excluded. The primary outcome was to determine SAPT vs. DAPT in terms of all-cause mortality, cardiac mortality, hospitalization for heart failure, myocardial infarction, and bleeding complications.

RESULTS: Among 199 patients, 114 met the inclusion criteria. Baseline mitral regurgitation was 3+ or 4+ in both groups. The acute success of the procedure was 100%. All patients were monitored for 12 months following treatment. Complications were uncommon and, in most cases, unrelated to antiplatelet therapy. Patients in the DAPT group had significantly poorer outcomes than those in the SAPT group, with 12-month survival freedom from all-cause mortality of 78.7% and 94% ( P  = 0.014) and survival freedom from cardiac mortality of 89.4% and 98.5% ( P  = 0.031).We observed no significant difference in major and minor bleeding between the two groups, although the incidence was higher in the DAPT group.

CONCLUSIONS: SAPT was associated with improved 12-month survival and a lower rate of bleeding events compared with DAPT in patients undergoing TEER. While individual rates of major and minor bleeding were not significantly different, the overall bleeding burden was reduced in the SAPT group. These findings suggest a potential association between SAPT and lower mortality rates and support its consideration in patients at high bleeding risk. Further prospective studies are warranted to confirm these observations.