Obesity has been associated with higher rates of adverse valve-related findings after transcatheter aortic valve replacement (TAVR), including hypo-attenuated leaflet thickening (HALT) and paravalvular leak (PVL). A prospective, randomized, open-label, multicenter trial published in Cardiovascular Revascularization Medicine evaluated whether tirzepatide could improve post-TAVR valve outcomes in patients with obesity.
The TAVR-MET trial enrolled 260 patients with obesity undergoing transfemoral TAVR, defined by body mass index (BMI) of at least 30 kg/m². Participants were randomized to receive tirzepatide started before TAVR and continued after the procedure or to standard care. The primary endpoint was HALT incidence at 6 months, assessed by four-dimensional computed tomography (4D-CT) or transesophageal echocardiography (TEE). Secondary endpoints included PVL severity, major adverse valve events, inflammatory biomarkers, weight reduction, and bleeding outcomes.
At 6 months, HALT occurred in 8.4% of patients receiving tirzepatide compared with 21.6% in the standard-care group (P=0.002). Rates of at least mild PVL were 10.7% vs 25.3%, respectively (P=0.006). Tirzepatide was also associated with lower C-reactive protein (CRP) levels and body weight, without an increase in major bleeding.
Multivariable analysis identified tirzepatide use, CRP reduction greater than 30%, and follow-up BMI below 32 kg/m² as independent predictors of HALT absence. These findings suggest that tirzepatide may improve valve-related outcomes after TAVR in patients with obesity.