Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: Insights from the DUTCH PEERS trial

M Lowik, L C Van Der Heijden, M M Kok, P Zocca, P W Danse, G A J Jessurun, R.W.M. Hautvast, M Hartmann, M G Stoel, G C M Linssen, C.J.M. Doggen, C Von Birgelen

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Abstract

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.
Original languageEnglish
Pages (from-to)620
Number of pages1
JournalEuropean heart journal
Volume38
Issue numberSupplement 1
DOIs
Publication statusPublished - 29 Aug 2017

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Stents
Chromium
zotarolimus
Everolimus
Incidence
Thrombosis
Myocardial Infarction
Safety
Drug-Eluting Stents
Lost to Follow-Up
Contracts
Cobalt
Platinum
Polymers
Research Personnel
Organizations
Equipment and Supplies

Keywords

  • Kaplan Meier method
  • adult
  • adverse device effect
  • blood vessel wall
  • clinical assessment
  • clinical outcome
  • conference abstract
  • controlled study
  • everolimus eluting coronary stent
  • female
  • follow up
  • heart death
  • heart infarction
  • human
  • incidence
  • log rank test
  • major clinical study
  • male
  • monitoring
  • multicenter study
  • organization
  • outcome assessment
  • polymer
  • randomized controlled trial
  • single blind procedure
  • stent thrombosis
  • syndrome
  • target vessel revascularization
  • treatment failure
  • unclassified drug
  • zotarolimus eluting coronary stent

Cite this

Lowik, M ; Van Der Heijden, L C ; Kok, M M ; Zocca, P ; Danse, P W ; Jessurun, G A J ; Hautvast, R.W.M. ; Hartmann, M ; Stoel, M G ; Linssen, G C M ; Doggen, C.J.M. ; Von Birgelen, C. / Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: Insights from the DUTCH PEERS trial. In: European heart journal. 2017 ; Vol. 38, No. Supplement 1. pp. 620.
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abstract = "Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5{\%}; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1{\%} vs. 12.1{\%}; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9{\%} vs. 3.7{\%}; Logrank p=0.78); target vessel-related MI (3.2{\%} vs. 2.5{\%}; Logrank p=0.38); and target vessel revascularization (6.8{\%} vs. 7.5{\%}; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5{\%} vs. 1.2{\%}; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.",
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Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: Insights from the DUTCH PEERS trial. / Lowik, M; Van Der Heijden, L C; Kok, M M; Zocca, P; Danse, P W; Jessurun, G A J; Hautvast, R.W.M.; Hartmann, M; Stoel, M G; Linssen, G C M; Doggen, C.J.M.; Von Birgelen, C.

In: European heart journal, Vol. 38, No. Supplement 1, 29.08.2017, p. 620.

Research output: Contribution to journalArticleAcademic

TY - JOUR

T1 - Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: Insights from the DUTCH PEERS trial

AU - Lowik, M

AU - Van Der Heijden, L C

AU - Kok, M M

AU - Zocca, P

AU - Danse, P W

AU - Jessurun, G A J

AU - Hautvast, R.W.M.

AU - Hartmann, M

AU - Stoel, M G

AU - Linssen, G C M

AU - Doggen, C.J.M.

AU - Von Birgelen, C

PY - 2017/8/29

Y1 - 2017/8/29

N2 - Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

AB - Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

KW - Kaplan Meier method

KW - adult

KW - adverse device effect

KW - blood vessel wall

KW - clinical assessment

KW - clinical outcome

KW - conference abstract

KW - controlled study

KW - everolimus eluting coronary stent

KW - female

KW - follow up

KW - heart death

KW - heart infarction

KW - human

KW - incidence

KW - log rank test

KW - major clinical study

KW - male

KW - monitoring

KW - multicenter study

KW - organization

KW - outcome assessment

KW - polymer

KW - randomized controlled trial

KW - single blind procedure

KW - stent thrombosis

KW - syndrome

KW - target vessel revascularization

KW - treatment failure

KW - unclassified drug

KW - zotarolimus eluting coronary stent

U2 - 10.1093/eurheartj/ehx504.2925

DO - 10.1093/eurheartj/ehx504.2925

M3 - Article

VL - 38

SP - 620

JO - European heart journal

JF - European heart journal

SN - 0195-668X

IS - Supplement 1

ER -