TY - JOUR
T1 - Final five-year results of the REMEDEE Registry: Real-world experience with the dual-therapy COMBO stent
AU - Kerkmeijer, Laura S. M.
AU - Chandrasekhar, Jaya
AU - Kalkman, Deborah N.
AU - Woudstra, Pier
AU - Menown, Ian B. A.
AU - Suryapranata, Harry
AU - den Heijer, Peter
AU - Iñiguez, Andrés
AU - van 't Hof, Arnoud W. J.
AU - Erglis, Andrejs
AU - Arkenbout, Karin E.
AU - Muller, Philippe
AU - Koch, Karel T.
AU - Tijssen, Jan G.
AU - Beijk, Marcel A. M.
AU - de Winter, Robbert J.
N1 - Funding Information: The Amsterdam UMC, location Academic Medical Center, University of Amsterdam received an unrestricted research grant from OrbusNeich Medical B.V., The Netherlands. Funding Information: 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. Publisher Copyright: © 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2021/9
Y1 - 2021/9
N2 - 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.
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.
KW - drug-eluting stent
KW - dual-therapy stent
KW - percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85092141322&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ccd.29305
DO - https://doi.org/10.1002/ccd.29305
M3 - Article
C2 - 33029937
SN - 1522-1946
VL - 98
SP - 503
EP - 510
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
IS - 3
ER -