Placement of Aortic Transcatheter Valves II - PARTNER II

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) with the Sapien XT device compared with the first-generation Sapien device among inoperable patients with severe aortic stenosis.

The Sapien XT device requires a 19 Fr sheath to implant a 26 mm valve, and an 18 Fr sheath to implant a 23 mm valve. The Sapien device requires a 24 Fr sheath to implant a 26 mm valve, and a 22 Fr sheath to implant a 23 mm valve.

Hypothesis:

The objective of the study was to compare the safety and efficacy of these two devices.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with severe aortic stenosis and inoperable for surgical AVR
  • Severe aortic stenosis defined by: aortic valve area <0.8 cm2, and mean aortic gradient >40 mm Hg or peak jet velocity >4 m/sec

    Number of enrollees: 560
    Duration of follow-up: 1 year
    Mean patient age: 84 years
    Percentage female: 50%
    Ejection fraction: 52%

Exclusions:

  • Aortic annulus <18 mm or >25 mm
  • Minimum iliac-femoral diameter <7 mm
  • Left ventricular dysfunction <20%
  • Need for coronary revascularization
  • Serum creatinine >3 mg/dl
  • Acute myocardial infarction within the last month
  • Stroke/TIA within the last 6 months
  • Hemodynamic instability

Primary Endpoints:

  • All-cause mortality, disabling stroke, or hospitalization at 1 year (noninferiority design)

Drug/Procedures Used:

Inoperable patients with severe aortic stenosis were randomized to transfemoral TAVR with the Sapien XT device (n = 284) versus the first-generation Sapien device (n = 276).

Concomitant Medications:

n/a

Principal Findings:

Overall, 560 patients were randomized. The mean age was 84 years, 50% were women, mean body mass index was 29 kg/m2, mean Society of Thoracic Surgeons (STS) risk score was 10.3, 11% had previous stroke, 31% had peripheral arterial disease, 36% had diabetes, 30% had chronic obstructive pulmonary disease, 35% had a history of cancer, 37% had atrial fibrillation, and 59% met criteria for inoperability based on frailty.

The mean left ventricular ejection fraction was 52%, mean aortic valve area was 0.6 cm2, and mean aortic valve gradient was 45 mm Hg.

The mean procedural time was 101 minutes with the Sapien XT device, and 110 minutes with the Sapien device (p = 0.18).

Aortic valve area at 1 year was 1.4 cm2 in the Sapien XT group vs. 1.5 cm2 in the Sapien group. The mean aortic valve gradient at 1 year was 11.9 mm Hg in the Sapien XT group vs. 10.8 mm Hg in the Sapien group. Moderate to severe aortic regurgitation at 1 year was observed in 29% of the Sapien XT group vs. 21% of the Sapien group (p = 0.20).

All-cause death, stroke, or hospitalization at 1 year occurred in 33.9% of the Sapien XT group vs. 34.7% of the Sapien group (pnoninferiority = 0.0034; psuperiority = 0.86).

- All-cause mortality at 1 year: 22.5% vs. 23.7% (p = 0.71), respectively
- Disabling stroke at 1 year: 4.5% vs. 4.6% (p = 0.93), respectively
- Hospitalization at 1 year: 17.4% vs. 19.0% (p = 0.69), respectively

- All-cause death, stroke, or hospitalization at 30 days: 17.0% of the Sapien XT group vs. 15.3% of the Sapien group (p = 0.60)
- All-cause death at 30 days: 3.5% vs. 5.1% (p = 0.36), respectively
- Disabling stroke at 30 days: 3.2% vs. 3.0% (p = 0.85), respectively

- Major vascular events at 30 days: 9.6% vs. 15.5% (p = 0.04), respectively
- Major bleeding at 30 days: 15.7% vs. 16.4% (p = 0.84), respectively

Interpretation:

Among inoperable patients with severe aortic stenosis, TAVR with the Sapien XT device was associated with multiple improvements compared with the first-generation Sapien device. Sapien XT significantly reduced vascular complications, with similar mortality and stroke rate at 30 days. The Sapien XT device met criteria for noninferiority compared with the Sapien device based on the composite outcome of death, stroke, or hospitalization at 1 year. The approval of the Sapien XT device for clinical use is eagerly awaited.

References:

Presented by Dr. Martin Leon at ACC.13, San Francisco, March 10, 2013.

Clinical Topics: Cardiac Surgery, Vascular Medicine, Atherosclerotic Disease (CAD/PAD)

Keywords: Heart Valve Prosthesis, Pulmonary Disease, Chronic Obstructive, Stroke, Neoplasms, Follow-Up Studies, Body Mass Index, Stroke Volume, Peripheral Arterial Disease, Diabetes Mellitus


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