Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents: A propensity-matched analysis

Deborah N. Kalkman, Marlies M. Kok, Liefke C. van der Heijden, Pier Woudstra, Marcel A.M. Beijk, Jan G.P. Tijssen, Clemens von Birgelen, Robbert J. de Winter

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Abstract

Aims: The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.

Methods and results: Patients from the REMEDEE registry (COMBO, n=1, 000) were matched with patients from the Dutch PEERS trial (PROMUS Element/Resolute Integrity, n=1, 811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79).

Conclusions: In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

Original languageEnglish
Pages (from-to)1202-1209
Number of pages8
JournalEuroIntervention
Volume13
Issue number10
DOIs
Publication statusPublished - 1 Nov 2017

Fingerprint

Percutaneous Coronary Intervention
Stents
Propensity Score
Thrombosis
Drug-Eluting Stents
Sirolimus
Acute Coronary Syndrome
Registries
Equipment and Supplies

Keywords

  • Clinical research
  • Clinical trials
  • Coronary occlusion
  • Drug-eluting stent
  • Stent thrombosis

Cite this

Kalkman, D. N., Kok, M. M., van der Heijden, L. C., Woudstra, P., Beijk, M. A. M., Tijssen, J. G. P., ... de Winter, R. J. (2017). Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents: A propensity-matched analysis. EuroIntervention, 13(10), 1202-1209. https://doi.org/10.4244/EIJ-D-17-00301
Kalkman, Deborah N. ; Kok, Marlies M. ; van der Heijden, Liefke C. ; Woudstra, Pier ; Beijk, Marcel A.M. ; Tijssen, Jan G.P. ; von Birgelen, Clemens ; de Winter, Robbert J. / Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents : A propensity-matched analysis. In: EuroIntervention. 2017 ; Vol. 13, No. 10. pp. 1202-1209.
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abstract = "Aims: The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.Methods and results: Patients from the REMEDEE registry (COMBO, n=1, 000) were matched with patients from the Dutch PEERS trial (PROMUS Element/Resolute Integrity, n=1, 811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27{\%} female and more than 50{\%} of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9{\%} in COMBO and 6.4{\%} in PROMUS Element/Resolute Integrity, HR 1.24 (95{\%} CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8{\%} vs. 0.9{\%}, p=0.79).Conclusions: In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.",
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Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents : A propensity-matched analysis. / Kalkman, Deborah N.; Kok, Marlies M.; van der Heijden, Liefke C.; Woudstra, Pier; Beijk, Marcel A.M.; Tijssen, Jan G.P.; von Birgelen, Clemens; de Winter, Robbert J.

In: EuroIntervention, Vol. 13, No. 10, 01.11.2017, p. 1202-1209.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents

T2 - A propensity-matched analysis

AU - Kalkman, Deborah N.

AU - Kok, Marlies M.

AU - van der Heijden, Liefke C.

AU - Woudstra, Pier

AU - Beijk, Marcel A.M.

AU - Tijssen, Jan G.P.

AU - von Birgelen, Clemens

AU - de Winter, Robbert J.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - Aims: The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.Methods and results: Patients from the REMEDEE registry (COMBO, n=1, 000) were matched with patients from the Dutch PEERS trial (PROMUS Element/Resolute Integrity, n=1, 811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79).Conclusions: In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

AB - Aims: The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.Methods and results: Patients from the REMEDEE registry (COMBO, n=1, 000) were matched with patients from the Dutch PEERS trial (PROMUS Element/Resolute Integrity, n=1, 811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79).Conclusions: In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

KW - Clinical research

KW - Clinical trials

KW - Coronary occlusion

KW - Drug-eluting stent

KW - Stent thrombosis

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U2 - 10.4244/EIJ-D-17-00301

DO - 10.4244/EIJ-D-17-00301

M3 - Article

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