Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial - PORTICO IDE

Contribution To Literature:

The PORTICO IDE trial showed that TAVR with the self-expanding Portico valve met criteria for noninferiority for safety and efficacy compared with commercially available TAVR valves.

Description:

The goal of the trial was to compare the safety and efficacy of TAVR with the self-expanding Portico valve compared with a commercially available TAVR valve among patients with extreme or high-risk patients with severe aortic stenosis (AS).

Study Design

Eligible patients were randomized in a 1:1 fashion to TAVR with either Portico (n = 381) or a commercial valve (n = 369).

  • Total number of enrollees: 750
  • Duration of follow-up: 1 year
  • Mean patient age: 83 years
  • Percentage female: 53%

Inclusion criteria:

  • High or extreme surgical risk
  • Degenerative symptomatic severe AS
  • Computed tomography-measured aortic annulus between 19 and 27 mm
  • Age ≥21 years
  • New York Heart Association class ≥II

Exclusion criteria:

  • Acute myocardial infarction/stroke within 30 days
  • Congenital unicuspid or bicuspid
  • Mixed aortic valve disease
  • Any coronary or peripheral procedure within prior 30 days
  • Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification that is continuous with calcium in the left ventricular outflow tract, severe (>3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise
  • Bleeding diathesis or coagulopathy
  • Cardiogenic shock
  • Life-expectancy <12 months

Other salient features/characteristics:

  • Mean Society of Thoracic Surgeons (STS)–predicted risk of mortality (PROM): 6.5%; ≥8%: 27%; extreme risk: 18%
  • Peripheral artery disease: 18%
  • Chronic lung disease: 41%
  • Mean gradient: 46 mm Hg

Principal Findings:

The primary safety endpoint of all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days, for Portico vs. commercial valve, was 13.8% vs. 9.6% (p = 0.03 for noninferiority).

  • All-cause mortality at 30 days: 3.5% vs. 1.9% (p = 0.2)
  • Disabling stroke at 30 days: 1.6% vs. 1.1% (p = 0.55)
  • Major vascular complications: 9.6% vs. 6.3% (p = 0.1)

The primary efficacy endpoint, all-cause mortality or disabling stroke at 1 year, was 14.9% for Portico vs. 13.4% for commercial valve (p = 0.006 for noninferiority).

  • All-cause mortality at 1 year: 22.3% vs. 20.2% (p = 0.40)
  • Disabling stroke at 1 year: 3.1% vs. 5.0% (p = 0.23)

Secondary outcomes for Portico vs. commercial valve:

  • New pacemaker: 27.7% vs. 11.6%
  • Mean aortic gradient at 1 year: 8.6 vs. 10.6 mm Hg (p < 0.0001)
  • Moderate to severe aortic regurgitation: 7.8% vs. 1.5% (p = 0.0005)
  • All-cause mortality at 2 years: 22.3% vs. 20.2% (p = 0.4)

Post hoc comparison for Portico vs. Edwards Sapien S3:

  • Moderate/severe paravalvular leak at 1 year: 7.6% vs. 1.3% (p = 0.006)
  • Mean gradient at 2 years: 8.1 vs. 11.5 mm Hg (p < 0.001)
  • Mortality at 2 years: 22.7% vs. 15.6% (p = 0.03)

Interpretation:

The results of this trial indicate that TAVR with the self-expanding Portico valve met criteria for noninferiority for safety and efficacy compared with commercially available TAVR valves (balloon-expandable Sapien, self-expanding CoreValve). Pacemaker rates, moderate to severe paravalvular leak, and major vascular complications were higher with Portico, while transvalvular gradients were lower.

These are important head-to-head comparison data. A post hoc analysis suggested better hemodynamics but worse outcomes compared with balloon-expandable Sapien S3. The delivery system used in the trial was their first-generation; a subsequent iteration with lower profile has been developed and in an accompanying nested registry, resulted in lower complication rates. Of note, the Food and Drug Administration (FDA) stopped the PORTICO IDE trial midway due to reports of valve-related thrombosis. The results of the leaflet motion substudy of this trial are eagerly awaited.

References:

Makkar RR, Cheng W, Waksman R, et al. Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial. Lancet 2020;396:669-83.

Presented by Dr. Gregory P. Fontana at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 27, 2019.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease

Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Blood Transfusion, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Renal Dialysis, Stroke, Tomography, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, TCT19, Thrombosis, Vascular Diseases


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