PARTNER IIA Findings Evaluate TAVR Versus SAVR Outcomes in Patients With Previous Cardiac Surgery

November 6, 2018—Findings from a comparison of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in patients with previous cardiac surgery (PCS) in the randomized PARTNER IIA trial were published by Shmuel Chen, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11: 2207–2216).

The investigators stated that the study evaluated clinical outcomes in patients with and without PCS, which has been shown to be associated with increased surgical risk and postoperative complications after SAVR, but whether this risk is similar in TAVR is unclear.

As summarized in JACC: Cardiovascular Interventions, the PARTNER IIA trial was composed of 2,032 patients with severe aortic stenosis at intermediate surgical risk who were randomized to TAVR with the Sapien XT valve (Edwards Lifesciences) or SAVR. The investigators compared adverse clinical outcomes at 30 days and 2 years using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The trial's primary endpoint was all-cause death and disabling stroke.

The investigators reported that 509 patients (25.1%) had PCS (98.2% coronary artery bypass grafting). There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years.

Nevertheless, an interaction was observed between PCS and treatment arm: patients without PCS who were treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio, 2.66; 95% confidence interval, 1.68 to 4.22) but the opposite was true in patients with PCS (adjusted hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.66) (P_interaction < .0001). A similar interaction was observed for life-threatening or disabling bleeding.

The relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS in the PARTNER IIA trial of intermediate-risk patients with severe aortic stenosis, concluded the investigators in JACC: Cardiovascular Interventions.