Abstract
Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).
Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.
Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.
Results: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).
Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.
| Original language | English |
|---|---|
| Pages (from-to) | 462-469 |
| Number of pages | 8 |
| Journal | JACC : cardiovascular interventions |
| Volume | 11 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 12 Mar 2018 |
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Keywords
- Long-term outcome
- Newer-generation drug-eluting stent(s)
- PCI
- Percutaneous coronary intervention
- PROMUS Element everolimus-eluting stent(s)
- Resolute Integrity zotarolimus-eluting stent(s)
- DES
Cite this
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5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents : Final Report of the DUTCH PEERS (TWENTE II) Trial. / Zocca, Paolo; Kok, Marlies M.; Tandjung, Kenneth; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; van Houwelingen, Gert K.; Stoel, Martin G.; Schramm, Alexander R.; Tjon Joe Gin, R. Melvyn; de Man, Frits H.A.F.; Hartmann, Marc; Louwerenburg, J. (Hans) W.; Linssen, Gerard C.M.; Löwik, Marije M.; Doggen, Carine J.M.; von Birgelen, Clemens (Corresponding Author).
In: JACC : cardiovascular interventions, Vol. 11, No. 5, 12.03.2018, p. 462-469.Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - 5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents
T2 - Final Report of the DUTCH PEERS (TWENTE II) Trial
AU - Zocca, Paolo
AU - Kok, Marlies M.
AU - Tandjung, Kenneth
AU - Danse, Peter W.
AU - Jessurun, Gillian A.J.
AU - Hautvast, Raymond W.M.
AU - van Houwelingen, Gert K.
AU - Stoel, Martin G.
AU - Schramm, Alexander R.
AU - Tjon Joe Gin, R. Melvyn
AU - de Man, Frits H.A.F.
AU - Hartmann, Marc
AU - Louwerenburg, J. (Hans) W.
AU - Linssen, Gerard C.M.
AU - Löwik, Marije M.
AU - Doggen, Carine J.M.
AU - von Birgelen, Clemens
PY - 2018/3/12
Y1 - 2018/3/12
N2 - Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.Results: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.
AB - Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.Results: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.
KW - Long-term outcome
KW - Newer-generation drug-eluting stent(s)
KW - PCI
KW - Percutaneous coronary intervention
KW - PROMUS Element everolimus-eluting stent(s)
KW - Resolute Integrity zotarolimus-eluting stent(s)
KW - DES
UR - http://www.scopus.com/inward/record.url?scp=85041405975&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2017.11.031
DO - 10.1016/j.jcin.2017.11.031
M3 - Article
VL - 11
SP - 462
EP - 469
JO - JACC : cardiovascular interventions
JF - JACC : cardiovascular interventions
SN - 1936-8798
IS - 5
ER -