PMID- 32593323
OWN - NLM
STAT- MEDLINE
DCOM- 20201009
LR  - 20201009
IS  - 1474-547X (Electronic)
IS  - 0140-6736 (Linking)
VI  - 396
IP  - 10252
DP  - 2020 Sep 5
TI  - 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.
PG  - 669-683
LID - S0140-6736(20)31358-1 [pii]
LID - 10.1016/S0140-6736(20)31358-1 [doi]
AB  - BACKGROUND: Randomised trial data assessing the safety and efficacy of the 
      self-expanding intra-annular Portico transcatheter aortic valve system (Abbott 
      Structural Heart, St Paul, MN, USA) compared with any commercially available 
      valves are needed to compare performance among designs. METHODS: In this 
      prospective, multicentre, non-inferiority, randomised controlled trial (the 
      Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device 
      Exemption trial [PORTICO IDE]), high and extreme risk patients with severe 
      symptomatic aortic stenosis were recruited from 52 medical centres experienced in 
      performing transcatheter aortic valve replacement in the USA and Australia. 
      Patients were eligible if they were aged 21 years or older, in New York Heart 
      Association functional class II or higher, and had severe native aortic stenosis. 
      Eligible patients were randomly assigned (1:1) using permuted block randomisation 
      (block sizes of 2 and 4) and stratified by clinical investigational site, 
      surgical risk cohort, and vascular access method, to transcatheter aortic valve 
      replacement with the first generation Portico valve and delivery system or a 
      commercially available valve (either an intra-annular balloon-expandable 
      Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, 
      USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve 
      [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting 
      physician, and study participant were unmasked to treatment assignment. Core 
      laboratories and clinical event assessors were masked to treatment allocation. 
      The primary safety endpoint was a composite of all-cause mortality, disabling 
      stroke, life-threatening bleeding requiring transfusion, acute kidney injury 
      requiring dialysis, or major vascular complication at 30 days. The primary 
      efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical 
      outcomes and valve performance were assessed up to 2 years after the procedure. 
      Primary analyses were by intention to treat and the Kaplan-Meier method to 
      estimate event rates. The non-inferiority margin was 8.5% for primary safety and 
      8.0% for primary efficacy endpoints. This study is registered with 
      ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS: Between May 30 and 
      Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment 
      paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were 
      eligible and randomly assigned to the Portico valve group (n=381) or commercially 
      available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52.7%) 
      patients were female. For the primary safety endpoint at 30 days, the event rate 
      was higher in the Portico valve group than in the commercial valve group (52 
      [13.8%] vs 35 [9.6%]; absolute difference 4.2, 95% CI -0.4 to 8.8 [upper 
      confidence bound UCB 8.1%]; p(non-inferiority)=0.034, p(superiority)=0.071). At 
      1 year, the rates of the primary efficacy endpoint were similar between the 
      groups (55 [14.8%] in the Portico group vs 48 [13.4%] in the commercial valve 
      group; difference 1.5%, 95% CI -3.6 to 6.5 [UCB 5.7%]; p(non-inferiority)=0.0058, 
      p(superiority)=0.50). At 2 years, rates of death (80 [22.3%] vs 70 [20.2%]; 
      p=0.40) or disabling stroke (10 [3.1%] vs 16 [5.0%]; p=0.23) were similar between 
      groups. INTERPRETATION: The Portico valve was associated with similar rates of 
      death or disabling stroke at 2 years compared with commercial valves, but was 
      associated with higher rates of the primary composite safety endpoint including 
      death at 30 days. The first-generation Portico valve and delivery system did not 
      offer advantages over other commercially available valves. FUNDING: Abbott.
CI  - Copyright (c) 2020 Elsevier Ltd. All rights reserved.
FAU - Makkar, Raj R
AU  - Makkar RR
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 
      Electronic address: raj.makkar@cshs.org.
FAU - Cheng, Wen
AU  - Cheng W
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
FAU - Waksman, Ron
AU  - Waksman R
AD  - Washington Hospital Center, Washington, DC, USA.
FAU - Satler, Lowell F
AU  - Satler LF
AD  - Washington Hospital Center, Washington, DC, USA.
FAU - Chakravarty, Tarun
AU  - Chakravarty T
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
FAU - Groh, Mark
AU  - Groh M
AD  - Mission Health and Hospitals, Asheville, NC, USA.
FAU - Abernethy, William
AU  - Abernethy W
AD  - Mission Health and Hospitals, Asheville, NC, USA.
FAU - Russo, Mark J
AU  - Russo MJ
AD  - Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA; Newark Beth 
      Israel Medical Center, Newark, NY, USA.
FAU - Heimansohn, David
AU  - Heimansohn D
AD  - St Vincent Heart Center, Indianapolis, IN, USA.
FAU - Hermiller, James
AU  - Hermiller J
AD  - St Vincent Heart Center, Indianapolis, IN, USA.
FAU - Worthley, Stephen
AU  - Worthley S
AD  - Royal Adelaide Hospital, Adelaide, SA, Australia; Genesis Care, Sydney, NSW, 
      Australia.
FAU - Chehab, Bassem
AU  - Chehab B
AD  - Cardiovascular Research Institute of Kansas, Ascension Via Christi Hospital, 
      Wichita, KS, USA.
FAU - Cunningham, Mark
AU  - Cunningham M
AD  - University of Southern California, Los Angeles, CA, USA.
FAU - Matthews, Ray
AU  - Matthews R
AD  - University of Southern California, Los Angeles, CA, USA.
FAU - Ramana, Ravi K
AU  - Ramana RK
AD  - Advocate Christ Medical Center, Oak Lawn, IL, USA; Heart Care Centers of 
      Illinois, Palos Park, IL, USA.
FAU - Yong, Gerald
AU  - Yong G
AD  - Fiona Stanley Hospital, Murdoch, WA, Australia.
FAU - Ruiz, Carlos E
AU  - Ruiz CE
AD  - Hackensack University Medical Center, Hackensack, NJ, USA.
FAU - Chen, Chunguang
AU  - Chen C
AD  - Newark Beth Israel Medical Center, Newark, NY, USA.
FAU - Asch, Federico M
AU  - Asch FM
AD  - MedStar Health Research Institute, Washington, DC, USA.
FAU - Nakamura, Mamoo
AU  - Nakamura M
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
FAU - Jilaihawi, Hasan
AU  - Jilaihawi H
AD  - NYU Langone Health, New York, NY, USA.
FAU - Sharma, Rahul
AU  - Sharma R
AD  - Stanford University Medical Center, Stanford, CA, USA.
FAU - Yoon, Sung-Han
AU  - Yoon SH
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
FAU - Pichard, Augusto D
AU  - Pichard AD
AD  - Abbott, Abbott Park, IL, USA.
FAU - Kapadia, Samir
AU  - Kapadia S
AD  - Cleveland Clinic, Cleveland, OH, USA.
FAU - Reardon, Michael J
AU  - Reardon MJ
AD  - Houston Methodist Hospital, Houston, TX, USA.
FAU - Bhatt, Deepak L
AU  - Bhatt DL
AD  - Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Fontana, Gregory P
AU  - Fontana GP
AD  - Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, CA, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02000115
PT  - Comparative Study
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200625
PL  - England
TA  - Lancet
JT  - Lancet (London, England)
JID - 2985213R
SB  - IM
EIN - Lancet. 2020 Sep 5;396(10252):668. PMID: 32619415
MH  - Acute Kidney Injury/epidemiology/therapy
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve Stenosis/*surgery
MH  - Australia
MH  - Blood Transfusion
MH  - Cause of Death
MH  - Female
MH  - *Heart Valve Prosthesis
MH  - Humans
MH  - Male
MH  - *Mortality
MH  - Postoperative Complications/*epidemiology/therapy
MH  - Postoperative Hemorrhage/epidemiology/therapy
MH  - *Prosthesis Design
MH  - Renal Dialysis
MH  - Severity of Illness Index
MH  - Stroke/*epidemiology
MH  - *Transcatheter Aortic Valve Replacement
MH  - Treatment Outcome
MH  - United States
EDAT- 2020/07/01 06:00
MHDA- 2020/10/10 06:00
CRDT- 2020/06/29 06:00
PHST- 2019/08/19 00:00 [received]
PHST- 2020/06/08 00:00 [revised]
PHST- 2020/06/09 00:00 [accepted]
PHST- 2020/07/01 06:00 [pubmed]
PHST- 2020/10/10 06:00 [medline]
PHST- 2020/06/29 06:00 [entrez]
AID - S0140-6736(20)31358-1 [pii]
AID - 10.1016/S0140-6736(20)31358-1 [doi]
PST - ppublish
SO  - Lancet. 2020 Sep 5;396(10252):669-683. doi: 10.1016/S0140-6736(20)31358-1. Epub 
      2020 Jun 25.