Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry

Deborah N. Kalkman, Laura S. Kerkmeijer, Pier Woudstra, Ian B. A. Menown, Harry Suryapranata, Peter den Heijer, Andrés Iñiguez, Arnoud W. J. van 't Hof, Andrejs Erglis, Karin E. Arkenbout, Philippe Muller, Karel T. Koch, Jan G. Tijssen, Marcel A. M. Beijk, Robbert J. de Winter

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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%.
Original languageEnglish
Pages (from-to)342-347
JournalCatheterization and Cardiovascular Interventions
Volume94
Issue number3
DOIs
Publication statusPublished - 1 Sep 2019
Externally publishedYes

Cite this

Kalkman, D. N., Kerkmeijer, L. S., Woudstra, P., Menown, I. B. A., Suryapranata, H., den Heijer, P., ... de Winter, R. J. (2019). Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry. Catheterization and Cardiovascular Interventions, 94(3), 342-347. https://doi.org/10.1002/ccd.28047
Kalkman, Deborah N. ; Kerkmeijer, Laura S. ; Woudstra, Pier ; Menown, Ian B. A. ; Suryapranata, Harry ; den Heijer, Peter ; Iñiguez, Andrés ; van 't Hof, Arnoud W. J. ; Erglis, Andrejs ; Arkenbout, Karin E. ; Muller, Philippe ; Koch, Karel T. ; Tijssen, Jan G. ; Beijk, Marcel A. M. ; de Winter, Robbert J. / Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry. In: Catheterization and Cardiovascular Interventions. 2019 ; Vol. 94, No. 3. pp. 342-347.
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title = "Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry",
abstract = "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{\%}.",
author = "Kalkman, {Deborah N.} and Kerkmeijer, {Laura S.} and Pier Woudstra and Menown, {Ian B. A.} and Harry Suryapranata and {den Heijer}, Peter and Andr{\'e}s I{\~n}iguez and {van 't Hof}, {Arnoud W. J.} and Andrejs Erglis and Arkenbout, {Karin E.} and Philippe Muller and Koch, {Karel T.} and Tijssen, {Jan G.} and Beijk, {Marcel A. M.} and {de Winter}, {Robbert J.}",
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Kalkman, DN, Kerkmeijer, LS, Woudstra, P, Menown, IBA, Suryapranata, H, den Heijer, P, Iñiguez, A, van 't Hof, AWJ, Erglis, A, Arkenbout, KE, Muller, P, Koch, KT, Tijssen, JG, Beijk, MAM & de Winter, RJ 2019, 'Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry' Catheterization and Cardiovascular Interventions, vol. 94, no. 3, pp. 342-347. https://doi.org/10.1002/ccd.28047

Three-year clinical outcomes after dual-therapy COMBO stent placement: Insights from the REMEDEE registry. / Kalkman, Deborah N.; Kerkmeijer, Laura S.; Woudstra, Pier; Menown, Ian B. A.; Suryapranata, Harry; den Heijer, Peter; Iñiguez, Andrés; van 't Hof, Arnoud W. J.; Erglis, Andrejs; Arkenbout, Karin E.; Muller, Philippe; Koch, Karel T.; Tijssen, Jan G.; Beijk, Marcel A. M.; de Winter, Robbert J.

In: Catheterization and Cardiovascular Interventions, Vol. 94, No. 3, 01.09.2019, p. 342-347.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Three-year clinical outcomes after dual-therapy COMBO stent placement: 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.

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%.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/30565371

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