Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents

Hanim Sen, Kenneth Tandjung, Mounir W.Z. Basalus, Marije M. Löwik, Gert K. van Houwelingen, Martin G. Stoel, Hans W. Louwerenburg, Frits H.A.F. de Man, Gerard C.M. Linssen, Rogier Nijhuis, Mark B. Nienhuis, Patrick M.J. Verhorst, Job van der Palen, Clemens von Birgelen

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Abstract

Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.

Methods and results: Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).

Conclusions: Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.
Original languageEnglish
Article number104
Pages (from-to)664-671
JournalEuroIntervention
Volume8
Issue number6
DOIs
Publication statusPublished - 2012

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Drug-Eluting Stents
Population
Stents
Diabetes Mellitus
History
Myocardial Infarction

Keywords

  • IR-82393
  • METIS-290183
  • Coronary artery disease
  • Percutaneous Coronary Intervention (PCI)
  • Drug-eluting stent(s)
  • Randomised controlled trial
  • TWENTE trial

Cite this

Sen, Hanim ; Tandjung, Kenneth ; Basalus, Mounir W.Z. ; Löwik, Marije M. ; van Houwelingen, Gert K. ; Stoel, Martin G. ; Louwerenburg, Hans W. ; de Man, Frits H.A.F. ; Linssen, Gerard C.M. ; Nijhuis, Rogier ; Nienhuis, Mark B. ; Verhorst, Patrick M.J. ; van der Palen, Job ; von Birgelen, Clemens . / Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents. In: EuroIntervention. 2012 ; Vol. 8, No. 6. pp. 664-671.
@article{e4a884c8e59249eda970bfe559e9a587,
title = "Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents",
abstract = "Aims: The TWENTE trial recently enrolled more than 80{\%} of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.Methods and results: Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8{\%} vs. 8.1{\%}; p=0.34), and its components cardiac death (1.6{\%} vs. 1.2{\%}; p=0.61), target vessel-related myocardial infarction (4.7{\%} vs. 4.6{\%}; p=0.92), and target-vessel revascularisation (3.8{\%} vs. 3.0{\%}; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3{\%} vs. 7.3{\%}; p=0.99).Conclusions: Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.",
keywords = "IR-82393, METIS-290183, Coronary artery disease, Percutaneous Coronary Intervention (PCI), Drug-eluting stent(s), Randomised controlled trial, TWENTE trial",
author = "Hanim Sen and Kenneth Tandjung and Basalus, {Mounir W.Z.} and L{\"o}wik, {Marije M.} and {van Houwelingen}, {Gert K.} and Stoel, {Martin G.} and Louwerenburg, {Hans W.} and {de Man}, {Frits H.A.F.} and Linssen, {Gerard C.M.} and Rogier Nijhuis and Nienhuis, {Mark B.} and Verhorst, {Patrick M.J.} and {van der Palen}, Job and {von Birgelen}, Clemens",
year = "2012",
doi = "10.4244/EIJV8I6A104",
language = "English",
volume = "8",
pages = "664--671",
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Sen, H, Tandjung, K, Basalus, MWZ, Löwik, MM, van Houwelingen, GK, Stoel, MG, Louwerenburg, HW, de Man, FHAF, Linssen, GCM, Nijhuis, R, Nienhuis, MB, Verhorst, PMJ, van der Palen, J & von Birgelen, C 2012, 'Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents' EuroIntervention, vol. 8, no. 6, 104, pp. 664-671. https://doi.org/10.4244/EIJV8I6A104

Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents. / Sen, Hanim; Tandjung, Kenneth; Basalus, Mounir W.Z.; Löwik, Marije M.; van Houwelingen, Gert K.; Stoel, Martin G.; Louwerenburg, Hans W.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Nijhuis, Rogier; Nienhuis, Mark B.; Verhorst, Patrick M.J.; van der Palen, Job; von Birgelen, Clemens .

In: EuroIntervention, Vol. 8, No. 6, 104, 2012, p. 664-671.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents

AU - Sen, Hanim

AU - Tandjung, Kenneth

AU - Basalus, Mounir W.Z.

AU - Löwik, Marije M.

AU - van Houwelingen, Gert K.

AU - Stoel, Martin G.

AU - Louwerenburg, Hans W.

AU - de Man, Frits H.A.F.

AU - Linssen, Gerard C.M.

AU - Nijhuis, Rogier

AU - Nienhuis, Mark B.

AU - Verhorst, Patrick M.J.

AU - van der Palen, Job

AU - von Birgelen, Clemens

PY - 2012

Y1 - 2012

N2 - Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.Methods and results: Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).Conclusions: Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.

AB - Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.Methods and results: Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).Conclusions: Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.

KW - IR-82393

KW - METIS-290183

KW - Coronary artery disease

KW - Percutaneous Coronary Intervention (PCI)

KW - Drug-eluting stent(s)

KW - Randomised controlled trial

KW - TWENTE trial

U2 - 10.4244/EIJV8I6A104

DO - 10.4244/EIJV8I6A104

M3 - Article

VL - 8

SP - 664

EP - 671

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 6

M1 - 104

ER -