TAVI Compares Favorably to Surgery in Italian Registry

February 23, 2012—One-year data comparing complications and outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) were published by Corrado Tamburino, MD, et al online ahead of print in the American Journal of Cardiology.

The investigators noted that comparisons of TAVI to SAVR in patients with severe aortic stenosis remain sparse or limited by a short follow-up duration. Therefore, they conducted this study to evaluate early and mid-term outcomes of consecutive patients (n = 618) undergoing successful TAVI (n = 218) or isolated SAVR (n = 400) at two centers in Italy.

The study's primary endpoint was incidence of Valvular Academic Research Consortium–defined major adverse cerebrovascular and cardiac events (MACCE) at up to 1 year. Control of potential confounders was attempted with extensive statistical adjustment by covariates and/or propensity score.

As detailed in the American Journal of Cardiology, the investigators found that in-hospital MACCE occurred in 73 patients (11.8%) and occurred more frequently in patients who were treated with SAVR compared to those treated with TAVI (7.8% vs 14%; P = .022). After addressing potential confounders using three methods of statistical adjustment, SAVR was consistently associated with a higher risk of MACCE than TAVI, with estimates of relative risk ranging from 2.2 to 2.6 at 30 days, 2.3 to 2.5 at 6 months, and 2 to 2.2 at 12 months. This difference was driven by an adjusted increased risk of life-threatening bleeding at 6 and 12 months and stroke at 12 months with SAVR. Conversely, no differences in adjusted risk of death, stroke, and myocardial infarction were noted between TAVI and SAVR at each time point.

In this large observational registry with admitted potential for selection bias and residual confounders, TAVI was not associated with a higher risk of 1-year MACCE compared to SAVR, concluded the investigators.