In the PARTNER 1 study, patients with inoperable severe aortic stenosis treated with an aortic valve prosthesis balloon-expandable Edwards-SAPIEN showed a mortality reduction compared with standard treatment. However, the Edwards SAPIEN device is associated with peri-procedural complications. The new generation of Edwards SAPIEN XT prosthesis incorporates significant improvements in the profile of the delivery system, which could lead to better clinical outcomes.

In the PARTNER II study the aim was to compare the results and security between the two prostheses also in patients considered inoperable. We randomized 500 patients 1:1 to receive Edwards SAPIEN XT or Edwards SAPIEN evaluating all-cause mortality, stroke and re-hospitalization. Patients were followed up for a minimum of one year and evaluated for the non-inferiority of treatment. 

Conclusions: In patients with significant symptoms who were not suitable candidates for conventional surgery, percutaneous replacement was superior to standard therapy with an incremental benefit of 1-2 years but kept the same rates of all-cause mortality, cardiovascular mortality and re-hospitalization as PARTNER I. At 30 days the incidence of death and stroke were similar in both groups, (comparing the two prostheses used). The SAPIEN XT group showed a significant reduction in peri-procedural complications such as perforation, dissection or hematoma (p <0.04). At one year the mortality and stroke rates were similar, maintaining a superiority in relation to peri-procedural complications. 

Panelists: David Holmes commented on improving patient profile, who although still “inoperable” would present a better choice, given current knowledge about the procedure. Martin Leon again commented on the stringent selection criteria and standardization of procedures and, also, an improved patient care after surgery.

Martin Leon
2013-03-12

Original title: A Randomized Evaluation of the SAPIEN XT Transcatheter Valve System in Patients with Aortic Stenosis who are not Candidates for Surgery: PARTNER 2, Cohort B Outcomes