Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting xience V stents in the randomized TWENTE trial: Comparison of 2-year clinical outcome

Hanim Sen, Ming Kai Lam, Kenneth Tandjung, Marije M. Löwik, Martin G. Stoel, Frits H.A.F. de Man, J. (Hans) W. Louwerenburg, Gert K. van Houwelingen, Gerard C.M. Linssen, Carine J.M. Doggen, Mounir W.Z. Basalus, Clemens von Birgelen

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

Objective: To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).

Background: Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).

Methods: We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES. Complex patients had at least one of the following characteristics: renal insufficiency (creatinine ≥ 140 µmol/l); ejection fraction < 30%; acute myocardial infarction (MI) within previous 72 hrs; >1 lesion/vessel; >2 vessels treated; lesion length > 27 mm; bifurcation; saphenous vein graft lesion; arterial bypass graft lesion; in-stent restenosis; unprotected left main lesion; lesion with thrombus; or lesion with total occlusion. Target vessel failure (TVF), the primary composite endpoint of the trial, was defined as cardiac death, target vessel-related MI, or target vessel revascularization.

Results: Among the 1,033 complex patients, 529 (51%) were treated with Resolute ZES and 504 (49%) with Xience V EES. Patient- and procedure-related characteristics were similar between DES groups. After 2-year follow-up, outcome was also similar between DES groups. TVF occurred in 12.1% of patients treated with Resolute ZES and 12.3% of patients treated with Xience V EES. In addition, DES groups did not differ significantly in cardiac death, MI, or target vessel revascularization—the individual components of TVF.

Conclusion: Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up.

Original languageEnglish
Pages (from-to)74-81
JournalCatheterization and cardiovascular interventions
Volume85
Issue number1
DOIs
Publication statusPublished - 14 Mar 2015

Fingerprint

Stents
Drug-Eluting Stents
zotarolimus
Everolimus
Transplants
Saphenous Vein
Percutaneous Coronary Intervention
Renal Insufficiency
Coronary Disease
Thrombosis
Safety

Keywords

  • METIS-304661
  • IR-91536
  • Drug-eluting stent(s)
  • Percutaneous Coronary Intervention (PCI)
  • TWENTE trial
  • Off-label

Cite this

Sen, Hanim ; Lam, Ming Kai ; Tandjung, Kenneth ; Löwik, Marije M. ; Stoel, Martin G. ; de Man, Frits H.A.F. ; Louwerenburg, J. (Hans) W. ; van Houwelingen, Gert K. ; Linssen, Gerard C.M. ; Doggen, Carine J.M. ; Basalus, Mounir W.Z. ; von Birgelen, Clemens. / Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting xience V stents in the randomized TWENTE trial : Comparison of 2-year clinical outcome. In: Catheterization and cardiovascular interventions. 2015 ; Vol. 85, No. 1. pp. 74-81.
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title = "Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting xience V stents in the randomized TWENTE trial: Comparison of 2-year clinical outcome",
abstract = "Objective: To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).Background: Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).Methods: We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES. Complex patients had at least one of the following characteristics: renal insufficiency (creatinine ≥ 140 µmol/l); ejection fraction < 30{\%}; acute myocardial infarction (MI) within previous 72 hrs; >1 lesion/vessel; >2 vessels treated; lesion length > 27 mm; bifurcation; saphenous vein graft lesion; arterial bypass graft lesion; in-stent restenosis; unprotected left main lesion; lesion with thrombus; or lesion with total occlusion. Target vessel failure (TVF), the primary composite endpoint of the trial, was defined as cardiac death, target vessel-related MI, or target vessel revascularization.Results: Among the 1,033 complex patients, 529 (51{\%}) were treated with Resolute ZES and 504 (49{\%}) with Xience V EES. Patient- and procedure-related characteristics were similar between DES groups. After 2-year follow-up, outcome was also similar between DES groups. TVF occurred in 12.1{\%} of patients treated with Resolute ZES and 12.3{\%} of patients treated with Xience V EES. In addition, DES groups did not differ significantly in cardiac death, MI, or target vessel revascularization—the individual components of TVF.Conclusion: Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up.",
keywords = "METIS-304661, IR-91536, Drug-eluting stent(s), Percutaneous Coronary Intervention (PCI), TWENTE trial, Off-label",
author = "Hanim Sen and Lam, {Ming Kai} and Kenneth Tandjung and L{\"o}wik, {Marije M.} and Stoel, {Martin G.} and {de Man}, {Frits H.A.F.} and Louwerenburg, {J. (Hans) W.} and {van Houwelingen}, {Gert K.} and Linssen, {Gerard C.M.} and Doggen, {Carine J.M.} and Basalus, {Mounir W.Z.} and {von Birgelen}, Clemens",
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Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting xience V stents in the randomized TWENTE trial : Comparison of 2-year clinical outcome. / Sen, Hanim; Lam, Ming Kai; Tandjung, Kenneth; Löwik, Marije M.; Stoel, Martin G.; de Man, Frits H.A.F.; Louwerenburg, J. (Hans) W.; van Houwelingen, Gert K.; Linssen, Gerard C.M.; Doggen, Carine J.M. ; Basalus, Mounir W.Z.; von Birgelen, Clemens.

In: Catheterization and cardiovascular interventions, Vol. 85, No. 1, 14.03.2015, p. 74-81.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting xience V stents in the randomized TWENTE trial

T2 - Comparison of 2-year clinical outcome

AU - Sen, Hanim

AU - Lam, Ming Kai

AU - Tandjung, Kenneth

AU - Löwik, Marije M.

AU - Stoel, Martin G.

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

AU - Louwerenburg, J. (Hans) W.

AU - van Houwelingen, Gert K.

AU - Linssen, Gerard C.M.

AU - Doggen, Carine J.M.

AU - Basalus, Mounir W.Z.

AU - von Birgelen, Clemens

PY - 2015/3/14

Y1 - 2015/3/14

N2 - Objective: To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).Background: Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).Methods: We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES. Complex patients had at least one of the following characteristics: renal insufficiency (creatinine ≥ 140 µmol/l); ejection fraction < 30%; acute myocardial infarction (MI) within previous 72 hrs; >1 lesion/vessel; >2 vessels treated; lesion length > 27 mm; bifurcation; saphenous vein graft lesion; arterial bypass graft lesion; in-stent restenosis; unprotected left main lesion; lesion with thrombus; or lesion with total occlusion. Target vessel failure (TVF), the primary composite endpoint of the trial, was defined as cardiac death, target vessel-related MI, or target vessel revascularization.Results: Among the 1,033 complex patients, 529 (51%) were treated with Resolute ZES and 504 (49%) with Xience V EES. Patient- and procedure-related characteristics were similar between DES groups. After 2-year follow-up, outcome was also similar between DES groups. TVF occurred in 12.1% of patients treated with Resolute ZES and 12.3% of patients treated with Xience V EES. In addition, DES groups did not differ significantly in cardiac death, MI, or target vessel revascularization—the individual components of TVF.Conclusion: Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up.

AB - Objective: To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).Background: Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).Methods: We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES. Complex patients had at least one of the following characteristics: renal insufficiency (creatinine ≥ 140 µmol/l); ejection fraction < 30%; acute myocardial infarction (MI) within previous 72 hrs; >1 lesion/vessel; >2 vessels treated; lesion length > 27 mm; bifurcation; saphenous vein graft lesion; arterial bypass graft lesion; in-stent restenosis; unprotected left main lesion; lesion with thrombus; or lesion with total occlusion. Target vessel failure (TVF), the primary composite endpoint of the trial, was defined as cardiac death, target vessel-related MI, or target vessel revascularization.Results: Among the 1,033 complex patients, 529 (51%) were treated with Resolute ZES and 504 (49%) with Xience V EES. Patient- and procedure-related characteristics were similar between DES groups. After 2-year follow-up, outcome was also similar between DES groups. TVF occurred in 12.1% of patients treated with Resolute ZES and 12.3% of patients treated with Xience V EES. In addition, DES groups did not differ significantly in cardiac death, MI, or target vessel revascularization—the individual components of TVF.Conclusion: Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up.

KW - METIS-304661

KW - IR-91536

KW - Drug-eluting stent(s)

KW - Percutaneous Coronary Intervention (PCI)

KW - TWENTE trial

KW - Off-label

U2 - 10.1002/ccd.25464

DO - 10.1002/ccd.25464

M3 - Article

VL - 85

SP - 74

EP - 81

JO - Catheterization and cardiovascular interventions

JF - Catheterization and cardiovascular interventions

SN - 1522-1946

IS - 1

ER -