SAVR vs TAVR: Adverse Outcomes Risk in Aortic Stenosis
There were more life-threatening or disabling bleeding events in patients with prior cardiac surgery treated with TAVR vs SAVR.
Surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) were associated with a similar relative risk for adverse outcomes at 2 years in patients with severe aortic stenosis (AS) who had and had not received prior cardiac surgery, according to a study presented at the European Society of Cardiology Congress 2018, held August 25-29 in Munich, Germany.
Patients with symptomatic and severe AS who presented with an estimated intermediate surgical risk based on the Society of Thoracic Surgeons (STS) mortality risk model were included in the study (N=2032). Investigators randomly assigned patients to undergo either TAVR (n=1011) or SAVR (n=1021). The number of patients who had had prior cardiac surgery in the TAVR and SAVR groups was 245 and 264, respectively, and the number of patients without PCS in the TAVR and SAVR groups was 766 and 757, respectively. In the intention-to-treat population, the primary end point was all-cause death and disabling stroke at 2-year follow-up.
With regard to the primary end point at 30 days and 2 years, no difference was found between TAVR and SAVR in patients with vs without prior cardiac surgery. However, a trend was found toward higher 30-day rates in the primary end point and all-cause mortality in the group who had not had prior cardiac surgery. Patients without prior cardiac surgery who were treated with TAVR experienced higher 30-day major vascular complication rates compared with patients treated with SAVR (adjusted hazard ratio [HR] 2.66; 95% CI, 1.68-4.22).
Comparatively, patients with prior cardiac surgery had lower 30-day rates of major vascular complications if they were treated with TAVR vs SAVR (adjusted HR 0.27; 95% CI, 0.11-0.66; Pinteraction<.0001). In addition, more life-threatening bleeding or disabling bleeding events were observed in patients with prior cardiac surgery treated with TAVR vs SAVR (adjusted HR 0.13; 95% CI, 0.08-0.21) but fewer events were observed in patients without prior cardiac surgery treated with TAVR (HR 0.24; 95% CI, 0.19-0.31; Pinteraction =.02).
Limitations of the analysis included the lack of power to assess outcomes based on the presence of prior cardiac surgery as well as and the potential for unmeasured confounders that may have influenced results.
The investigators reported that the findings support “the long-term efficacy of both TAVR and SAVR in patients with [prior cardiac surgery], with a possible early safety advantage for TAVR versus SAVR.”
Disclosures: This study was funded by Edwards Lifesciences. Several authors have received financial support from pharmaceutical and medical device companies.
Chen S, Redfors B, Ben-Yehuda O, et al. Transcatheter versus surgical aortic valve replacement in patients with prior cardiac curgery in the randomized PARTNER 2A trial [published online August 28, 2018]. JACC Cardiovasc Interv. doi:10.1016/j.jcin.2018.08.006