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Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial.

Abstract Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title jama
Publication Year Start




PMID- 29297076
OWN - NLM
STAT- In-Process
LR  - 20180103
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 319
IP  - 1
DP  - 2018 Jan 2
TI  - Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve
      Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients 
      With Aortic Stenosis: The REPRISE III Randomized Clinical Trial.
PG  - 27-37
LID - 10.1001/jama.2017.19132 [doi]
AB  - Importance: Transcatheter aortic valve replacement (TAVR) is established for
      selected patients with severe aortic stenosis. However, limitations such as
      suboptimal deployment, conduction disturbances, and paravalvular leak occur.
      Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to
      an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis
      undergoing TAVR. Design, Setting, and Participants: The REPRISE III trial was
      conducted in 912 patients with high or extreme risk and severe, symptomatic
      aortic stenosis at 55 centers in North America, Europe, and Australia between
      September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017.
      Interventions: Participants were randomized in a 2:1 ratio to receive either an
      MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures: The primary safety
      end point was the 30-day composite of all-cause mortality, stroke,
      life-threatening or major bleeding, stage 2/3 acute kidney injury, and major
      vascular complications tested for noninferiority (margin, 10.5%). The primary
      effectiveness end point was the 1-year composite of all-cause mortality,
      disabling stroke, and moderate or greater paravalvular leak tested for
      noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary
      end point of 1-year moderate or greater paravalvular leak was tested for
      superiority in the full analysis data set. Results: Among 912 randomized patients
      (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality,
      6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point
      at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients
      (difference, 3.1%; Farrington-Manning 97.5% CI, -infinity to 8.3%; P = .003 for
      noninferiority). At 1 year, the primary effectiveness composite end point
      occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%;
      Farrington-Manning 97.5% CI, -infinity to -4.4%; P<.001 for noninferiority). The 
      1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and
      6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The
      superiority analysis for primary effectiveness was statistically significant
      (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates
      of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5%
      vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve
      deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and 
      Relevance: Among high-risk patients with aortic stenosis, use of the MEV compared
      with the SEV did not result in inferior outcomes for the primary safety end point
      or the primary effectiveness end point. These findings suggest that the MEV may
      be a useful addition for TAVR in high-risk patients. Trial Registration:
      ClinicalTrials.gov Identifier: NCT02202434.
FAU - Feldman, Ted E
AU  - Feldman TE
AD  - Evanston Hospital Cardiology Division, Northshore University Health System,
      Evanston, Illinois.
FAU - Reardon, Michael J
AU  - Reardon MJ
AD  - Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and
      Vascular Center, Houston, Texas.
FAU - Rajagopal, Vivek
AU  - Rajagopal V
AD  - Piedmont Heart Institute, Atlanta, Georgia.
FAU - Makkar, Raj R
AU  - Makkar RR
AD  - Cedars-Sinai Heart Institute, Los Angeles, California.
FAU - Bajwa, Tanvir K
AU  - Bajwa TK
AD  - Aurora St Luke's Medical Center, Milwaukee, Wisconsin.
FAU - Kleiman, Neal S
AU  - Kleiman NS
AD  - Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center,
      Houston, Texas.
FAU - Linke, Axel
AU  - Linke A
AD  - University of Leipzig, Heart Center and Leipzig Heart Institute, Leipzig,
      Germany.
FAU - Kereiakes, Dean J
AU  - Kereiakes DJ
AD  - Christ Hospital Heart and Vascular Center/Lindner Research Center, Cincinnati,
      Ohio.
FAU - Waksman, Ron
AU  - Waksman R
AD  - Washington Hospital Center, Washington, DC.
FAU - Thourani, Vinod H
AU  - Thourani VH
AD  - Washington Hospital Center, Washington, DC.
FAU - Stoler, Robert C
AU  - Stoler RC
AD  - Baylor Heart and Vascular Hospital, Dallas, Texas.
FAU - Mishkel, Gregory J
AU  - Mishkel GJ
AD  - St John's Hospital, Springfield, Illinois.
FAU - Rizik, David G
AU  - Rizik DG
AD  - HonorHealth and the Scottsdale-Lincoln Health Network, Scottsdale, Arizona.
FAU - Iyer, Vijay S
AU  - Iyer VS
AD  - University at Buffalo/Gates Vascular Institute, Buffalo, New York.
FAU - Gleason, Thomas G
AU  - Gleason TG
AD  - University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
FAU - Tchetche, Didier
AU  - Tchetche D
AD  - Clinique Pasteur, Toulouse, France.
FAU - Rovin, Joshua D
AU  - Rovin JD
AD  - Morton Plant Mease Healthcare System, Clearwater, Florida.
FAU - Buchbinder, Maurice
AU  - Buchbinder M
AD  - Foundation for Cardiovascular Medicine, Stanford University, Stanford,
      California.
FAU - Meredith, Ian T
AU  - Meredith IT
AD  - Boston Scientific Corp, Marlborough, Massachusetts.
FAU - Gotberg, Matthias
AU  - Gotberg M
AD  - Department of Cardiology, Clinical Sciences, Lund University, Skane University
      Hospital, Lund, Sweden.
FAU - Bjursten, Henrik
AU  - Bjursten H
AD  - Department of Cardiothoracic Surgery, Clinical Sciences, Lund University, Skane
      University University Hospital, Lund, Sweden.
FAU - Meduri, Christopher
AU  - Meduri C
AD  - Piedmont Heart Institute, Atlanta, Georgia.
FAU - Salinger, Michael H
AU  - Salinger MH
AD  - Evanston Hospital Cardiology Division, Northshore University Health System,
      Evanston, Illinois.
FAU - Allocco, Dominic J
AU  - Allocco DJ
AD  - Boston Scientific Corp, Marlborough, Massachusetts.
FAU - Dawkins, Keith D
AU  - Dawkins KD
AD  - Boston Scientific Corp, Marlborough, Massachusetts.
LA  - eng
SI  - ClinicalTrials.gov/NCT02202434
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2018/01/04 06:00
MHDA- 2018/01/04 06:00
CRDT- 2018/01/04 06:00
PHST- 2018/01/04 06:00 [entrez]
PHST- 2018/01/04 06:00 [pubmed]
PHST- 2018/01/04 06:00 [medline]
AID - 2667721 [pii]
AID - 10.1001/jama.2017.19132 [doi]
PST - ppublish
SO  - JAMA. 2018 Jan 2;319(1):27-37. doi: 10.1001/jama.2017.19132.