PMID- 33029937
OWN - NLM
STAT- MEDLINE
DCOM- 20211019
LR  - 20220531
IS  - 1522-726X (Electronic)
IS  - 1522-1946 (Print)
IS  - 1522-1946 (Linking)
VI  - 98
IP  - 3
DP  - 2021 Sep
TI  - Final five-year results of the REMEDEE Registry: Real-world experience with the 
      dual-therapy COMBO stent.
PG  - 503-510
LID - 10.1002/ccd.29305 [doi]
AB  - OBJECTIVES: This final report from the REMEDEE Registry assessed the long-term 
      safety and efficacy of the dual-therapy COMBO stent in a large unselected patient 
      population. BACKGROUND: The bio-engineered COMBO stent (OrbusNeich Medical BV, 
      The Netherlands) is a dual-therapy pro-healing stent. Data of long-term safety 
      and efficacy of the this stent is lacking. METHODS: The prospective, multicenter, 
      investigator-initiated REMEDEE Registry evaluated clinical outcomes after COMBO 
      stent implantation in daily clinical practice. One thousand patients were 
      enrolled between June 2013 and March 2014. RESULTS: Five-year follow-up data were 
      obtained in 97.2% of patients. At 5-years, target lesion failure (TLF) (composite 
      of cardiac death, target-vessel myocardial infarction, or target lesion 
      revascularization) was present in 145 patients (14.8%). Definite or probable 
      stent thrombosis (ST) occurred in 0.9%, with no additional case beyond 3-years of 
      follow-up. In males, 5-year TLF-rate was 15.6 versus 12.6% in females (p = .22). 
      Patients without diabetes mellitus (DM) had TLF-rate of 11.4%, noninsulin-treated 
      DM 22.7% (p = .001) and insulin-treated DM 41.2% (p < .001). Patients presenting 
      with non-ST segment elevation acute coronary syndrome (NSTE-ACS) had higher 
      incidence of TLF compared to non-ACS (20.4 vs. 13.3%; p = .008), while incidence 
      with STE-ACS was comparable to non-ACS (10.7 vs. 13.3%; p = .43). CONCLUSION: 
      Percutaneous coronary intervention with the dual-therapy COMBO stent in 
      unselected patient population shows low rates of TLF and ST to 5 years. 
      Remarkably, no case of ST was noted beyond 3 years.
CI  - (c) 2020 The Authors. Catheterization and Cardiovascular Interventions published by 
      Wiley Periodicals LLC.
FAU - Kerkmeijer, Laura S M
AU  - Kerkmeijer LSM
AUID- ORCID: 0000-0003-0873-2014
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
FAU - Chandrasekhar, Jaya
AU  - Chandrasekhar J
AUID- ORCID: 0000-0001-8776-326X
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
AD  - Department of Cardiology, Icahn School of Medicine at Mount Sinai Hospital, New 
      York, USA.
FAU - Kalkman, Deborah N
AU  - Kalkman DN
AUID- ORCID: 0000-0002-1900-2116
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
FAU - Woudstra, Pier
AU  - Woudstra P
AUID- ORCID: 0000-0002-5870-9923
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
FAU - Menown, Ian B A
AU  - Menown IBA
AD  - Department of Cardiology, Craigavon Cardiac Centre, Craigavon, UK.
FAU - Suryapranata, Harry
AU  - Suryapranata H
AD  - Department of Cardiology, Radboud University Medical Center, Nijmegen, The 
      Netherlands.
FAU - den Heijer, Peter
AU  - den Heijer P
AD  - Department of Cardiology, Amphia Hospital Breda, Breda, The Netherlands.
FAU - Iniguez, Andres
AU  - Iniguez A
AD  - Department of Cardiology, Hospital Alvaro Cunqueiro - Complejo Hospitalario 
      Universitario, Vigo, Spain.
FAU - van 't Hof, Arnoud W J
AU  - van 't Hof AWJ
AD  - Department of Cardiology, Isala Klinieken, Zwolle, the Netherlands.
FAU - Erglis, Andrejs
AU  - Erglis A
AD  - Department of Cardiology, Pauls Stradins Clinical University Hospital, Riga, 
      Latvia.
FAU - Arkenbout, Karin E
AU  - Arkenbout KE
AD  - Department of Cardiology, Tergooi Ziekenhuis, Blaricum, The Netherlands.
FAU - Muller, Philippe
AU  - Muller P
AD  - Department of Cardiology, Institut National de Cardiochirurgie et de Cardiologie 
      Interventionnelle, Luxembourg, Luxembourg.
FAU - Koch, Karel T
AU  - Koch KT
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
FAU - Tijssen, Jan G
AU  - Tijssen JG
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
FAU - Beijk, Marcel A M
AU  - Beijk MAM
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
FAU - de Winter, Robbert J
AU  - de Winter RJ
AD  - Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular 
      Sciences, Amsterdam UMC, Heart Center, Amsterdam, The Netherlands.
LA  - eng
GR  - Orbus Neich BV/
GR  - OrbusNeich Medical B.V./
GR  - OrbusNeich, AstraZeneca, and Tryton/
GR  - The Medicines Company/
GR  - Biotronik, Biosensors, and Medtronic/
GR  - Abbott Vascular and Boson Scientific/
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201008
PL  - United States
TA  - Catheter Cardiovasc Interv
JT  - Catheterization and cardiovascular interventions : official journal of the 
      Society for Cardiac Angiography & Interventions
JID - 100884139
SB  - IM
MH  - *Coronary Artery Disease/diagnostic imaging/therapy
MH  - *Drug-Eluting Stents
MH  - Female
MH  - Humans
MH  - Male
MH  - *Percutaneous Coronary Intervention
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Registries
MH  - Risk Factors
MH  - Stents
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC8518525
OTO - NOTNLM
OT  - drug-eluting stent
OT  - dual-therapy stent
OT  - percutaneous coronary intervention
COIS- All including centers received institutional grants. Dr. Erglis has received 
      grant support and personal fee from Abbott Vascular and Boson Scientific; and 
      consultant fee from Biotronik, Biosensors, and Medtronic. Dr. van 't Hof has 
      received grant support from The Medicines Company and grant support from Abbott. 
      Dr. de Winter has received grant support from OrbusNeich, AstraZeneca, and 
      Tryton; and consultant fee from OrbusNeich. All other authors have reported that 
      they have no relationships relevant to the contents of this article to disclose.
EDAT- 2020/10/09 06:00
MHDA- 2021/10/21 06:00
PMCR- 2021/10/15
CRDT- 2020/10/08 05:38
PHST- 2020/08/26 00:00 [revised]
PHST- 2020/06/29 00:00 [received]
PHST- 2020/09/21 00:00 [accepted]
PHST- 2020/10/09 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2020/10/08 05:38 [entrez]
PHST- 2021/10/15 00:00 [pmc-release]
AID - CCD29305 [pii]
AID - 10.1002/ccd.29305 [doi]
PST - ppublish
SO  - Catheter Cardiovasc Interv. 2021 Sep;98(3):503-510. doi: 10.1002/ccd.29305. Epub 
      2020 Oct 8.