Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis - CHOICE

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve versus a self-expandable valve among high-risk patients with iliac arteries suitable for transfemoral access.

The CHOICE trial showed that a balloon-expandable valve was superior to a self-expandable valve due to a lower risk of significant aortic regurgitation and need for permanent pacemaker.

Study Design

  • Randomized
  • Placebo Controlled

Patient Populations:

  • Severe aortic stenosis (aortic valve area ≤1.0 cm2, or indexed aortic valve area ≤0.6 cm2/m2)
  • High-risk patients (>75 years of age, logistic EuroSCORE ≥20%, STS score of ≥10%, or contraindications to surgical AVR)
  • Aortic annulus between 20 and 27 mm
  • Suitability for transfemoral access

    Number of screened applicants: 405
    Number of enrollees: 241
    Duration of follow-up: 30 days
    Mean patient age: 82 years
    Percentage female: 57%
    Ejection fraction: 53%
    New York Heart Association class: I–6%, II–14%, III–60%, IV–20%

Exclusions:

  • Aortic annulus <20 mm or >27 mm
  • Prior aortic valve replacement
  • Hemodynamic instability
  • Active endocarditis or other active infection
  • Life expectancy <12 months
  • Gastrointestinal bleeding within the last 3 months
  • Contraindication to aspirin, clopidogrel, or heparin
  • Planned elective surgery within the next 3 months
  • Participation in another study

Primary Endpoints:

  • Device success was defined as the composite of: 1) successful vascular access, delivery, deployment, and retrieval of the delivery system, 2) correct position of the device, 3) mean gradient <20 mm Hg with < moderate aortic regurgitation, and 4) only one valve implanted in the proper location
  • Aortic regurgitation was primarily determined by immediate post-procedure angiography, but corroborated by echocardiography

Secondary Endpoints:

  • Cardiovascular mortality
  • Bleeding and vascular complications
  • Post-procedural pacemaker placement
  • All-cause mortality, major stroke, or serious complication at 30 days

Drug/Procedures Used:

Patients with obstructive coronary artery disease were recommended to undergo revascularization with drug-eluting stents and maintain clopidogrel for 3 months.

High-risk patients with severe aortic stenosis undergoing TAVR were randomized to a balloon-expandable valve (Edwards Sapien XT; n = 121) versus a self-expandable valve (Medtronic CoreValve; n = 120).

The balloon-expandable valve was deployed during rapid ventricular pacing. The self-expandable valve was deployed without pacing or slow-rapid pacing.

Principal Findings:

Overall, 241 patients were randomized. In the balloon-expandable valve group, the mean age was 82 years, 57% were women, mean logistic EuroSCORE was 21.5, mean Society of Thoracic Surgeons (STS) risk score was 5.6, 31% had diabetes, 60% had coronary artery disease, 22% had cerebrovascular disease, 17% had peripheral vascular disease, 22% had pulmonary disease, and 33% had atrial fibrillation.

By preprocedural echo, the mean aortic valve area was 0.7 cm2, mean aortic valve gradient was 43 mm Hg, mean left ventricular ejection fraction was 53%, ≥ moderate aortic regurgitation was present in 14%, ≥ moderate mitral regurgitation was present in 37%, and ≥ moderate tricuspid regurgitation was present in 30%.

By preprocedural multidetector computed tomography (CT), the mean aortic annulus diameter was 24 mm, mean area was 457 mm2, and mean left coronary height was 14 mm.

The implanted valve size relative to the mean aortic annulus was oversized 20% in the balloon-expandable group versus 31% in the self-expandable group (p < 0.001). Post-dilation was performed in 20% of the balloon-expandable group versus 49% of the self-expandable group (p < 0.001).

Device success occurred in 95.9% of the balloon-expandable valve group versus 77.5% of the self-expandable valve group (p < 0.001). This was due to a lower frequency of final ≥ moderate aortic regurgitation assessed by angiography: 4.1% vs. 18.3% (p < 0.001), respectively. Final ≥ moderate aortic regurgitation assessed by echocardiography was less severe, but still different between groups: 1.6% vs. 5.8% (p = 0.005), respectively. There was also a lower frequency of needing to implant more than one valve: 0.8% vs. 5.8% (p = 0.03), respectively, for a balloon-expandable versus a self-expandable valve.

- Cardiovascular mortality at 30 days: 4.1% vs. 4.3% (p = 0.99), respectively
- Major bleeding: 19% vs. 15% (p = 0.36), respectively
- Vascular complications: 14% vs. 13% (p = 0.78), respectively
- Stroke: 5.8% vs. 2.6% (p = 0.33), respectively
- Need for permanent pacemaker: 17% vs. 38% (p = 0.001), respectively
- Coronary obstruction: 1.6% vs. 0 (p = 0.49), respectively
- Annular rupture: 0 vs. 0

One-year results:

- All-cause mortality at 1 year: 17.4% vs. 12.8% (p = 0.37), respectively

- Stroke at 1 year: 9.1% vs. 3.4% (p = 0.11), respectively

- Hospitalization for heart failure at 1 year: 7.4% vs. 12.8% (p = 0.19), respectively

- Valve thrombosis at 1 year: 3.4% vs. 0% (p = 0.12), respectively

- Need for permanent pacemaker at 1 year: 23% vs. 38% (p = 0.001), respectively

In the self-expanding valve group, 71% with ≥ moderate aortic regurgitation at discharge had ≤ mild aortic regurgitation at 1 year. However, 20% of the self-expanding valve group with mild aortic regurgitation at discharge progressed to a moderate leak at 1 year, resulting in a neutral effect.

Interpretation:

Among high-risk patients with severe aortic stenosis undergoing TAVR, the device success of a balloon-expandable valve was superior to a self-expandable valve. This was due to a lower frequency of ≥ moderate aortic regurgitation and less need for an additional valve implant compared with the balloon-expandable valve group. Moderate or greater aortic regurgitation has been associated with late mortality. This study revealed that echocardiography underestimated the degree of aortic regurgitation compared with angiography.

Four patients in the balloon-expandable valve group developed valve thrombosis, which resolved with anticoagulation therapy. Some patients with the self-expandable valve reduced their severity of aortic regurgitation, while others increased their degree of paravalvular regurgitation with long-term follow-up. Therefore, long-term clinical outcomes appeared similar between the two groups. The self-expandable valve was also associated with a high need for permanent pacemaker (38%), which was approximately two-fold higher than the balloon-expandable valve. The degree of implant oversize was generous (especially among the self-expandable group), but fortunately, there were no annular ruptures in either group. Future studies will need to determine which patients are best served by a self-expandable valve (i.e., valve in valve procedures or minimal calcification of the aortic valve).

References:

Abdel-Wahab M, Neumann FJ, Mehilli J, et al. 1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial. J Am Coll Cardiol 2015;66:791-800.

Abdel-Wahab M, Mehilli J, Frerker C, et al., on behalf of the CHOICE Investigators. Comparison of Balloon-Expandable vs Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: The CHOICE Randomized Clinical Trial. JAMA 2014;311:1503-14.

Presented by Dr. Mohamed Abdel-Wahab at the American College of Cardiology Scientific Session, Washington, DC, March 30, 2014.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Cardiac Surgery and VHD, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging, Mitral Regurgitation

Keywords: Heart Valve Prosthesis, Coronary Artery Disease, Stroke, Drug-Eluting Stents, Tricuspid Valve Insufficiency, Mitral Valve Insufficiency, Ticlopidine, Iliac Artery, Peripheral Vascular Diseases, Multidetector Computed Tomography, Stroke Volume, Diabetes Mellitus, Echocardiography, Lung Diseases, ACC Annual Scientific Session


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