TY - JOUR
T1 - Three-year clinical outcomes after dual-therapy COMBO stent placement
T2 - Insights from the REMEDEE registry
AU - Kalkman, Deborah N.
AU - Kerkmeijer, Laura S.
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: information OrbusNeich Medical B.V.All patients, catheterization laboratory nurses and interventional cardiologists are greatly acknowledged for their participation and efforts regarding the REMEDEE Registry. The Academic Medical Center – University of Amsterdam received an unrestricted research grant from OrbusNeich Medical B.V., the Netherlands. Publisher Copyright: © 2018 Wiley Periodicals, Inc.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - Background: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent. Methods and results: The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT. Conclusions: At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes. Clinicaltrials.gov identifier: NCT01874002. Condensed abstract: The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%.
AB - Background: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent. Methods and results: The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT. Conclusions: At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes. Clinicaltrials.gov identifier: NCT01874002. Condensed abstract: The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%.
KW - coronary artery disease
KW - drug eluting stent
KW - interventional devices/innovation
KW - percutaneous coronary intervention
KW - stent restenosis
KW - stent thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85058838319&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85058838319&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30565371
U2 - https://doi.org/10.1002/ccd.28047
DO - https://doi.org/10.1002/ccd.28047
M3 - Article
C2 - 30565371
SN - 1522-1946
VL - 94
SP - 342
EP - 347
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
IS - 3
ER -