A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients : The TWENTE Trial

Clemens von Birgelen (Corresponding Author), Mounir W.Z. Basalus, Kenneth Tandjung, K. Gert van Houwelingen, Martin G. Stoel, J. (Hans) W. Louwerenburg, Gerard C.M. Linssen, Salah A.M. Said, Miep A.W.J. Kleijne, Hanim Sen, Marije M. Löwik, Job van der Palen, Patrick M.J. Verhorst, Frits H.A.F. de Man

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Abstract

Objectives: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.

Background: Only 1 randomized trial previously compared these stents.

Methods: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.

Results: Acute coronary syndromes were present in 52% and “off-label” feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: −2.8% to 3.0%, pnoninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.

Conclusions: Resolute ZES were noninferior to Xience V EES in treating “real-world” patients with a vast majority of complex lesions and “off-label” indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650
Original languageEnglish
Pages (from-to)1350-1361
JournalJournal of the American College of Cardiology
Volume59
Issue number15
DOIs
Publication statusPublished - 2012

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Stents
Randomized Controlled Trials
Drug-Eluting Stents
Dilatation
Thrombosis
zotarolimus
Everolimus
Intention to Treat Analysis
Acute Coronary Syndrome
Blood Vessels
Biomarkers
Myocardial Infarction
Research Personnel

Keywords

  • IR-82382
  • METIS-290140
  • Coronary artery disease
  • Drug-eluting stent(s)
  • Percutaneous Coronary Intervention (PCI)
  • Randomized controlled trial

Cite this

von Birgelen, Clemens ; Basalus, Mounir W.Z. ; Tandjung, Kenneth ; van Houwelingen, K. Gert ; Stoel, Martin G. ; Louwerenburg, J. (Hans) W. ; Linssen, Gerard C.M. ; Said, Salah A.M. ; Kleijne, Miep A.W.J. ; Sen, Hanim ; Löwik, Marije M. ; van der Palen, Job ; Verhorst, Patrick M.J. ; de Man, Frits H.A.F. / A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients : The TWENTE Trial. In: Journal of the American College of Cardiology. 2012 ; Vol. 59, No. 15. pp. 1350-1361.
@article{e4d8f80b23e14c0cbe8df45ca2f1afba,
title = "A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients : The TWENTE Trial",
abstract = "Objectives: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.Background: Only 1 randomized trial previously compared these stents.Methods: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4{\%} of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100{\%} follow-up data available). Analysis was by intention-to-treat.Results: Acute coronary syndromes were present in 52{\%} and “off-label” feature in 77{\%} of patients. Of the lesions, 70{\%} were type B2/C; the post-dilation rate was very high (82{\%}). In ZES and EES, TVF occurred in 8.2{\%} and 8.1{\%}, respectively (absolute risk-difference 0.1{\%}; 95{\%} confidence interval: −2.8{\%} to 3.0{\%}, pnoninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9{\%} and 1.2{\%}, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58{\%} and 0{\%}, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.Conclusions: Resolute ZES were noninferior to Xience V EES in treating “real-world” patients with a vast majority of complex lesions and “off-label” indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650",
keywords = "IR-82382, METIS-290140, Coronary artery disease, Drug-eluting stent(s), Percutaneous Coronary Intervention (PCI), Randomized controlled trial",
author = "{von Birgelen}, Clemens and Basalus, {Mounir W.Z.} and Kenneth Tandjung and {van Houwelingen}, {K. Gert} and Stoel, {Martin G.} and Louwerenburg, {J. (Hans) W.} and Linssen, {Gerard C.M.} and Said, {Salah A.M.} and Kleijne, {Miep A.W.J.} and Hanim Sen and L{\"o}wik, {Marije M.} and {van der Palen}, Job and Verhorst, {Patrick M.J.} and {de Man}, {Frits H.A.F.}",
year = "2012",
doi = "10.1016/j.jacc.2012.01.008",
language = "English",
volume = "59",
pages = "1350--1361",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier",
number = "15",

}

von Birgelen, C, Basalus, MWZ, Tandjung, K, van Houwelingen, KG, Stoel, MG, Louwerenburg, JHW, Linssen, GCM, Said, SAM, Kleijne, MAWJ, Sen, H, Löwik, MM, van der Palen, J, Verhorst, PMJ & de Man, FHAF 2012, 'A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients : The TWENTE Trial' Journal of the American College of Cardiology, vol. 59, no. 15, pp. 1350-1361. https://doi.org/10.1016/j.jacc.2012.01.008

A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients : The TWENTE Trial. / von Birgelen, Clemens (Corresponding Author); Basalus, Mounir W.Z.; Tandjung, Kenneth; van Houwelingen, K. Gert; Stoel, Martin G.; Louwerenburg, J. (Hans) W. ; Linssen, Gerard C.M.; Said, Salah A.M.; Kleijne, Miep A.W.J.; Sen, Hanim; Löwik, Marije M.; van der Palen, Job; Verhorst, Patrick M.J.; de Man, Frits H.A.F.

In: Journal of the American College of Cardiology, Vol. 59, No. 15, 2012, p. 1350-1361.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients : The TWENTE Trial

AU - von Birgelen, Clemens

AU - Basalus, Mounir W.Z.

AU - Tandjung, Kenneth

AU - van Houwelingen, K. Gert

AU - Stoel, Martin G.

AU - Louwerenburg, J. (Hans) W.

AU - Linssen, Gerard C.M.

AU - Said, Salah A.M.

AU - Kleijne, Miep A.W.J.

AU - Sen, Hanim

AU - Löwik, Marije M.

AU - van der Palen, Job

AU - Verhorst, Patrick M.J.

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

PY - 2012

Y1 - 2012

N2 - Objectives: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.Background: Only 1 randomized trial previously compared these stents.Methods: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.Results: Acute coronary syndromes were present in 52% and “off-label” feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: −2.8% to 3.0%, pnoninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.Conclusions: Resolute ZES were noninferior to Xience V EES in treating “real-world” patients with a vast majority of complex lesions and “off-label” indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650

AB - Objectives: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.Background: Only 1 randomized trial previously compared these stents.Methods: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.Results: Acute coronary syndromes were present in 52% and “off-label” feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: −2.8% to 3.0%, pnoninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.Conclusions: Resolute ZES were noninferior to Xience V EES in treating “real-world” patients with a vast majority of complex lesions and “off-label” indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650

KW - IR-82382

KW - METIS-290140

KW - Coronary artery disease

KW - Drug-eluting stent(s)

KW - Percutaneous Coronary Intervention (PCI)

KW - Randomized controlled trial

U2 - 10.1016/j.jacc.2012.01.008

DO - 10.1016/j.jacc.2012.01.008

M3 - Article

VL - 59

SP - 1350

EP - 1361

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 15

ER -