4994Transcatheter versus surgical aortic valve replacement in patients with prior cardiac surgery in the randomized PARTNER 2A Trial

Abstract

Background: Prior cardiac surgery (PCS) is associated with increased risk and post‐op complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear. Purpose: To evaluate clinical outcomes in pts with and without PCS undergoing TAVR or SAVR. Methods: In the PARTNER 2A trial, 2032 pts with severe AS at intermediate surgical risk (STS 4‐8) were randomized to TAVR with SAPIEN XT or SAVR. Outcomes at 30d and 2y were compared using KM event rates, and association of PCS with outcomes was assessed using multivariable Cox models. The primary endpoint was all cause death and disabling stroke. Results: 509 pts (25.1%) had PCS. Pts with PCS were younger, with higher BMI and STS score, and were more often male and diabetic. There were no significant differences between TAVR and SAVR in patients with or without PCS, in rates of the primary endpoint or its components at 30d (Table). Bleeding was significantly higher in SAVR in both PCS groups (Figure), but an interaction between PCS group and treatment arm was observed for bleeding, driven by life threatening or disabling bleeding, such that the gap between bleeding rates was more pro‐found in PCS pts (adjusted TAVR vs SAVR HR [95% CI]: 0.13 [0.08, 0.21] for PCS vs 0.24 [0.19, 0.31] for no‐PCS; adj p‐interaction=0.02). 2‐year clinical outcomes did not differ significantly between TAVR and SAVR, in pts with or without PCS. 80 [Figure Presented] Conclusions: In the PARTNER 2A Trial of intermediate‐risk pts with severe AS undergoing SAVR versus TAVR with SAPIEN XT, the relative risk of 30‐day life‐threatening bleeding associated with SAVR was disproportionately higher amongst patients with PCS compared to those without PCS. Contrary to prior re‐ports in high‐risk patients, two‐year clinical outcomes in intermediate‐risk patients with PCS were similar for SAVR and TAVR. Funding Acknowledgements: The PARTNER 2 Trial was funded by Edwards Lifesciences.