• Interventional Techniques & Devices Cardiology Clinical Trials

• Interventional Techniques & Devices
• Cardiology & Cardiovascular Medicine
• Cardiology Clinical Trials

Results from the Placement of Aortic Transcatheter Valves 2 trial [PARTNER 2; NCT01314313] indicated that the new SAPIEN XT transcatheter heart valve (THV) system is noninferior to the old SAPIEN system when used in an inoperable cohort of patients. The new slimmer version was associated with improved procedural outcomes and reduced vascular complications, including major vascular bleeding. Martin B. Leon, MD, Columbia University Medical Center and New York-Presbyterian Hospital, New York, New York, USA, presented the results of PARTNER 2.

The objective of PARTNER 2 was to compare the safety and effectiveness of the new balloon-expandable SAPIEN XT with the old SAPIEN system in a randomized controlled trial of patients with symptomatic severe aortic stenosis who could not have surgery. The longer-profile SAPIEN XT incorporates important enhancements to the valve support frame, the valve leaflet geometry, the delivery system, and a significant reduction in sheath size designed to improve clinical outcomes.

This noninferiority trial included patients with severe aortic stenosis, NYHA Class ≥II and ≥50% risk of death or of serious irreversible morbidity as assessed by a cardiologist and 2 surgeons. After being assessed for inoperability and transfemoral access, patients (n=560) were randomly assigned 1:1 to THV replacement with either the SAPIEN XT or SAPIEN system. The primary study endpoint was a composite of all-cause mortality, disabling stroke, and rehospitalization for symptoms of aortic stenosis and/or complications of the valve procedure at 1 year.

Randomized patients (n=560) were 50% female, a mean age of 84 years, and had a mean Society of Thoracic Surgeons (STS) score of 10.3. More than half (59%) were deemed inoperable due to frailty.

At 12 months, SAPIEN XT was noninferior for the primary endpoint compared with SAPIEN (33.9% vs 34.7%; HR, 0.97; 95% CI, 0.73 to 1.30; p for noninferiority= 0.0034; p for superiority=0.863; Figure 1). There was no significant difference in all-cause mortality at 12 months between the SAPIEN XT and SAPIEN groups (22.5% vs 23.7%; HR, 0.93; 95% CI, 0.66 to 1.33; p=0.706; Figure 2). There were also no significant differences between the 2 groups in the number of disabling strokes or rehospitalization events.

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Figure 1.

All-Cause Mortality, Disabling Stroke, and Rehospitalization

Reproduced with permission from MB Leon, MD.

There were no significant differences between the SAPIEN XT and SAPIEN groups at 30 days for the primary endpoint (17.0% vs 15.3%; p=0.60), all-cause mortality (3.5% vs 5.1%; p=0.36), or disabling stroke (3.2% vs 3.0%; p=0.85).

There were lower rates of major vascular complications with SAPIEN XT (9.6% vs 15.5%; p=0.04). Disabling bleeding was also numerically lower but not statistically significantly lower with SAPIEN XT (7.8% vs 12.6%; p=0.06).

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Figure 2.

All-Cause Mortality

Reproduced with permission from MB Leon, MD.

SAPIEN XT was associated with numeric reductions in anesthesia time (197.6 vs 212.0 minutes; p=0.02), need for multiple (≥2) valve implants (3 vs 10; p=0.05), aborted procedures (2 vs 8; p=0.06), and need for intra-aortic balloon pump support during the procedure (1 vs 6; p=0.06) compared with SAPIEN.

By 1 year, >80% of patients were categorized as NYHA Class I or II heart failure after either intervention. Increases in echocardiographic value area, and reductions in mean and peak gradients based on as-treated analyses were similar for both devices at 30 days and persisted to 1 year. Values for total aortic regurgitation were also similar.

Dr. Leon said that the SAPIEN XT system represents a worthwhile advance with incremental clinical value and is now considered the preferred balloon-expandable THV system.

• © 2013 MD Conference Express®