PMID- 30810703
OWN - NLM
STAT- MEDLINE
DCOM- 20200131
LR  - 20200309
IS  - 2380-6591 (Electronic)
IS  - 2380-6583 (Print)
VI  - 4
IP  - 3
DP  - 2019 Mar 1
TI  - Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs 
      Self-expanding Valves: The REPRISE III Randomized Clinical Trial.
PG  - 223-229
LID - 10.1001/jamacardio.2019.0091 [doi]
AB  - IMPORTANCE: To our knowledge, REPRISE III is the first large randomized 
      comparison of 2 different transcatheter aortic valve replacement platforms: the 
      mechanically expanded Lotus valve (Boston Scientific) and self-expanding 
      CoreValve (Medtronic). OBJECTIVE: To evaluate outcomes of Lotus vs CoreValve 
      after 2 years. DESIGN, SETTING, AND PARTICIPANTS: A total of 912 patients with 
      high/extreme risk and severe, symptomatic aortic stenosis enrolled between 
      September 22, 2014, and December 24, 2015, were randomized 2:1 to receive Lotus 
      (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, 
      and Australia. The first 2-year visit occurred on October 17, 2016, and the last 
      was conducted on April 12, 2018. Clinical and echocardiographic assessments are 
      complete through 2 years and will continue annually through 5 years. MAIN 
      OUTCOMES AND MEASURES: All-cause mortality and all-cause mortality or disabling 
      stroke at 2 years. Other clinical factors included overall stroke, disabling 
      stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker 
      implantation. Echocardiographic analyses included effective orifice area, mean 
      gradient, and paravalvular leaks (PVLs). RESULTS: Of 912 participants, the mean 
      (SD) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of 
      Thoracic Surgeons predicted risk of mortality was 6.8% (4.0%). At 2 years, 
      all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 
      0.94; 95% CI, 0.69-1.26; P = .67) and all-cause mortality or disabling stroke was 
      22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P = .14). 
      Overall stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); 
      disabling stroke was more frequent with CoreValve vs Lotus (4.7% Lotus vs 8.6% 
      CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P = .02). More Lotus patients received a 
      new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P < .01) or 
      had a valve thrombosis (3.0% vs 0.0%; P < .01) compared with CoreValve. More 
      patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 
      2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P < .01), valve migration (0.0% vs 
      0.7%; P = .05), or embolization (0.0% vs 2.0%; P < .01) than Lotus. Valve areas 
      remained significantly larger and the mean gradient was lower with CoreValve than 
      Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] 
      cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm 
      Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% 
      Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York 
      Heart Association (NYHA) functional class were observed with Lotus compared with 
      CoreValve (improved by >/=1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 
      of 189 [75.7%]; P = .01; improved by >/=2 NYHA classes: 122 of 402 [37.3%] vs 65 of 
      305 [21.3%]). CONCLUSIONS AND RELEVANCE: After 2 years, all-cause mortality 
      rates, mortality or disabling stroke were similar between Lotus and CoreValve. 
      Disabling stroke, functional class, valve migration, and PVL favored the Lotus 
      arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation 
      favored the CoreValve arm. TRIAL REGISTRATION: clinicaltrials.gov Identifier: 
      NCT02202434.
FAU - Reardon, Michael J
AU  - Reardon MJ
AD  - Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and 
      Vascular Center, Houston, Texas.
FAU - Feldman, Ted E
AU  - Feldman TE
AD  - Evanston Hospital Cardiology Division, Northshore University Health System, 
      Evanston, Illinois.
FAU - Meduri, Christopher U
AU  - Meduri CU
AD  - Piedmont Heart Institute, Atlanta, Georgia.
FAU - Makkar, Raj R
AU  - Makkar RR
AD  - Cedars-Sinai Heart Institute, Los Angeles, California.
FAU - O'Hair, Daniel
AU  - O'Hair D
AD  - Aurora St Luke's Medical Center, Milwaukee, Wisconsin.
FAU - Linke, Axel
AU  - Linke A
AD  - Heart Center Dresde, Dresden University Hospital, Dresden, Germany.
FAU - Kereiakes, Dean J
AU  - Kereiakes DJ
AD  - The Lindner Research Center, The Christ Hospital Heart and Vascular Center, 
      Cincinnati, Ohio.
FAU - Waksman, Ron
AU  - Waksman R
AD  - Washington Hospital Center, Washington, DC.
FAU - Babliaros, Vasilis
AU  - Babliaros V
AD  - Emory University, Emory University Hospital, Atlanta, Georgia.
FAU - Stoler, Robert C
AU  - Stoler RC
AD  - Baylor Heart & 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, Scottsdale-Lincoln Health Network, Scottsdale, Arizona.
FAU - Iyer, Vijay S
AU  - Iyer VS
AD  - Gates Vascular Institute, University at Buffalo, 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  - Department of Internal Medicine/Cardiology, Herzzentrum Dresden, Technische 
      Universitat Dresden, Dresden, Germany.
FAU - Rovin, Joshua D
AU  - Rovin JD
AD  - Morton Plant Mease Healthcare System, Clearwater, Florida.
FAU - Lhermusier, Thibault
AU  - Lhermusier T
AD  - Clinique Pasteur, Toulouse, France.
FAU - Carrie, Didier
AU  - Carrie D
AD  - Clinique Pasteur, Toulouse, France.
FAU - Hodson, Robert W
AU  - Hodson RW
AD  - Providence St Vincent Medical Center, Portland, Oregon.
FAU - Allocco, Dominic J
AU  - Allocco DJ
AD  - Boston Scientific Corp, Marlborough, Massachusetts.
FAU - Meredith, Ian T
AU  - Meredith IT
AD  - Boston Scientific Corp, Marlborough, Massachusetts.
CN  - Reprise III Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02202434
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA Cardiol
JT  - JAMA cardiology
JID - 101676033
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/pathology
MH  - Aortic Valve Stenosis/diagnostic imaging/pathology/*surgery
MH  - Australia/epidemiology
MH  - Boston/epidemiology
MH  - Echocardiography/methods
MH  - Europe/epidemiology
MH  - Female
MH  - Heart Valve Prosthesis/*adverse effects/statistics & numerical data
MH  - Humans
MH  - Male
MH  - Patient Readmission/statistics & numerical data
MH  - Prosthesis Design/trends
MH  - Severity of Illness Index
MH  - Stroke/etiology
MH  - Thrombosis/etiology
MH  - Transcatheter Aortic Valve Replacement/*methods/mortality
MH  - Treatment Outcome
PMC - PMC6439548
COIS- Conflict of Interest Disclosures: Dr Reardon reported research grants from 
      Medtronic and Boston Scientific during the conduct of the study. Dr Feldman 
      reported grants and personal fees from Abbott, BSC, and Edwards during the 
      conduct of the study. Dr Makkar reported grants from Abbott and Edwards 
      Lifesciences; personal fees from Cordis, Medtronic, and Cedars-Sinai Medical 
      Center; and nonfinancial support from Cordis, and Cedars-Sinai Medical Center. Dr 
      Linke reported grants from Medtronic, Boston Scientific, and Claret Medical; 
      consulting fees and speaker honoraria from Boston Scientific, Medtronic, Bayer, 
      Astra Zeneca, and Abbott; speaker honoraria from Symetis; and being a stock 
      option owner with Claret Medical, Emboline, and Transverse Medical. Dr Kereiakes 
      reported grants, personal fees, and other from Boston Scientific. Dr Waksman 
      reported personal fees from Boston Scientific and Amgen; grants and personal fees 
      from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, and 
      Chiesi; personal fees from Cardioset, Cardiovascular Systems Inc, Medtronic, 
      Philips Volcano, and Pi-Cardia Ltd; and being an investor in MedAlliance. Dr 
      Babliaros reported consulting fees from Edwards Lifesciences and Abbott Vascular 
      outside the submitted work. Dr Stoler reported personal fees from Boston 
      Scientific and Medtronic and nonfinancial support from Edwards Lifesciences. Dr 
      Mishkel reported personal fees from Boston Scientific. Dr Rizik reported 
      royalties, serving as a member of the executive physician council, receiving 
      grant/research support, and receiving consulting/proctor fees from Boston 
      Scientific. Dr Iyer reported grants and proctor fees from Boston Scientific. Dr 
      Gleason reported grants from Boston Scientific and Medtronic and serving on the 
      medical advisory board for Abbott. Dr Rovin reported receiving trial funding from 
      Morton Plant Hospital/Baycare and personal fees from Medtronic and Abbott. Dr 
      Lhermusier reported grants, nonfinancial support, and personal fees from Boston 
      Scientific. Dr Allocco reported being a full-time employee and stockholder of 
      Boston Scientific. Dr Meredith reported personal fees from Boston Scientific. No 
      other disclosures were reported.
EDAT- 2019/02/28 06:00
MHDA- 2020/02/01 06:00
PMCR- 2020/02/27
CRDT- 2019/02/28 06:00
PHST- 2019/02/28 06:00 [pubmed]
PHST- 2020/02/01 06:00 [medline]
PHST- 2019/02/28 06:00 [entrez]
PHST- 2020/02/27 00:00 [pmc-release]
AID - 2725867 [pii]
AID - hoi190005 [pii]
AID - 10.1001/jamacardio.2019.0091 [doi]
PST - ppublish
SO  - JAMA Cardiol. 2019 Mar 1;4(3):223-229. doi: 10.1001/jamacardio.2019.0091.