Italian OBSERVANT Study Compares 1-Year Outcomes for TAVR and Surgery

August 17, 2015—Corrado Tamburino, MD, et al published results from the Italian OBSERVANT study in the Journal of the American College of Cardiology  (JACC; 2015;66:804–812). In this analysis, the investigators aim to describe 1-year clinical outcomes of a large series of propensity-matched patients undergoing transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. 

As summarized in JACC, the OBSERVANT trial is an observational, prospective, multicenter cohort study that enrolled patients with aortic stenosis who underwent SAVR or TAVR. The propensity score method was applied to select two groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year.

The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 transfemoral TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate–risk population (mean logistic EuroSCORE 1: SAVR, 10.2% ± 9.2% vs TAVR, 9.5% ± 7.1%). 

The investigators reported that at 1 year, the rate of death from any cause was 13.6% in the SAVR group and 13.8% in the TAVR group. Similarly, there were no significant differences in the MACCE rates, which were 17.6% in the SAVR group and 18.2% in the TAVR group. The cumulative incidence of cerebrovascular events and rehospitalization for cardiac reasons and acute heart failure was similar in both groups at 1 year.

The investigators concluded in JACC that the results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rehospitalization rates because of cardiac reasons at 1 year; however, they advised that these data need to be confirmed in longer-term and dedicated ongoing randomized trials.