Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial

COMPLETE-NSTEMI Investigators; Hans-Josef Feistritzer; Alexander Jobs; Uwe Zeymer; Steffen Schneider; Philipp Lauten; Miroslaw Ferenc; Maren Weferling; Regine Brinkmann; Sebastian Winkler; Ulf Landmesser; Tobias Trippel; Christoph Stellbrink; Harm Wienbergen; Georg Fürnau; Helge Möllmann; Axel Linke; Christian Jung; Alexander Lauten; Stephan Achenbach; Tienush Rassaf; Thomas Schmitz; Sebastian Cremer; Christoph Olivier; Volker Schächinger; Samuel Sossalla; Karl Toischer; Christian Templin; Daniel Sedding; Peter Clemmensen; Eike Tigges; Felix Meincke; Haitham Abu Sharar; Saarraaken Kulenthiran; P Christian Schulze; Claudius Jacobshagen; Derk Frank; Stephan Baldus; Ralf Lehmann; Christian Spies; Norbert Klein; Ingo Eitel; Ralf Zahn; Alexander Schmeisser; Tommaso Gori; Philipp Lurz; Ibrahim Akin; Georgios Chatzis; Konstantinos Rizas; Thorsten Kessler; Fadil Ademaj; Holger Thiele

doi:10.1016/j.ahj.2025.04.007

Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial

COMPLETE-NSTEMI Investigators, Hans-Josef Feistritzer, Alexander Jobs, Uwe Zeymer, Steffen Schneider, Philipp Lauten, Miroslaw Ferenc, Maren Weferling, Regine Brinkmann, Sebastian Winkler, Ulf Landmesser, Tobias Trippel, Christoph Stellbrink, Harm Wienbergen, Georg Fürnau, Helge Möllmann, Axel Linke, Christian Jung, Alexander Lauten, Stephan AchenbachTienush Rassaf, Thomas Schmitz, Sebastian Cremer, Christoph Olivier, Volker Schächinger, Samuel Sossalla, Karl Toischer, Christian Templin, Daniel Sedding, Peter Clemmensen, Eike Tigges, Felix Meincke, Haitham Abu Sharar, Saarraaken Kulenthiran, P Christian Schulze, Claudius Jacobshagen, Derk Frank, Stephan Baldus, Ralf Lehmann, Christian Spies, Norbert Klein, Ingo Eitel, Ralf Zahn, Alexander Schmeisser, Tommaso Gori, Philipp Lurz, Ibrahim Akin, Georgios Chatzis, Konstantinos Rizas, Thorsten Kessler, Fadil Ademaj, Holger Thiele^*

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

Abstract

BACKGROUND: Multivessel coronary artery disease (CAD) is present in 30-70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population.

PRIMARY HYPOTHESIS: The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD.

DESIGN: COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI.

ENDPOINTS: The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for non-fatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached.

CURRENT STATUS: The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028.

OUTLOOK: COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD.

TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT05786131.

Originalsprog	Engelsk
Sider (fra-til)	94-106
Antal sider	13
Tidsskrift	American heart journal
Vol/bind	287
DOI	https://doi.org/10.1016/j.ahj.2025.04.007
Status	Udgivet, E-publikation før trykning - 8 apr. 2025

Adgang til dokumentet

10.1016/j.ahj.2025.04.007

Citationsformater

COMPLETE-NSTEMI Investigators, Feistritzer, H.-J., Jobs, A., Zeymer, U., Schneider, S., Lauten, P., Ferenc, M., Weferling, M., Brinkmann, R., Winkler, S., Landmesser, U., Trippel, T., Stellbrink, C., Wienbergen, H., Fürnau, G., Möllmann, H., Linke, A., Jung, C., Lauten, A., ... Thiele, H. (2025). Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial. American heart journal, 287, 94-106. Advance online publication. https://doi.org/10.1016/j.ahj.2025.04.007

@article{1863a819e65545f9b5a91d95d0998e06,

title = "Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial",

abstract = "BACKGROUND: Multivessel coronary artery disease (CAD) is present in 30-70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population.PRIMARY HYPOTHESIS: The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD.DESIGN: COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI.ENDPOINTS: The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for non-fatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached.CURRENT STATUS: The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028.OUTLOOK: COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD.TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT05786131.",

author = "{COMPLETE-NSTEMI Investigators} and Hans-Josef Feistritzer and Alexander Jobs and Uwe Zeymer and Steffen Schneider and Philipp Lauten and Miroslaw Ferenc and Maren Weferling and Regine Brinkmann and Sebastian Winkler and Ulf Landmesser and Tobias Trippel and Christoph Stellbrink and Harm Wienbergen and Georg F{\"u}rnau and Helge M{\"o}llmann and Axel Linke and Christian Jung and Alexander Lauten and Stephan Achenbach and Tienush Rassaf and Thomas Schmitz and Sebastian Cremer and Christoph Olivier and Volker Sch{\"a}chinger and Samuel Sossalla and Karl Toischer and Christian Templin and Daniel Sedding and Peter Clemmensen and Eike Tigges and Felix Meincke and Sharar, {Haitham Abu} and Saarraaken Kulenthiran and Schulze, {P Christian} and Claudius Jacobshagen and Derk Frank and Stephan Baldus and Ralf Lehmann and Christian Spies and Norbert Klein and Ingo Eitel and Ralf Zahn and Alexander Schmeisser and Tommaso Gori and Philipp Lurz and Ibrahim Akin and Georgios Chatzis and Konstantinos Rizas and Thorsten Kessler and Fadil Ademaj and Holger Thiele",

year = "2025",

month = apr,

day = "8",

doi = "10.1016/j.ahj.2025.04.007",

language = "English",

volume = "287",

pages = "94--106",

journal = "American heart journal",

issn = "0002-8703",

publisher = "Elsevier",

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COMPLETE-NSTEMI Investigators, Feistritzer, H-J, Jobs, A, Zeymer, U, Schneider, S, Lauten, P, Ferenc, M, Weferling, M, Brinkmann, R, Winkler, S, Landmesser, U, Trippel, T, Stellbrink, C, Wienbergen, H, Fürnau, G, Möllmann, H, Linke, A, Jung, C, Lauten, A, Achenbach, S, Rassaf, T, Schmitz, T, Cremer, S, Olivier, C, Schächinger, V, Sossalla, S, Toischer, K, Templin, C, Sedding, D, Clemmensen, P, Tigges, E, Meincke, F, Sharar, HA, Kulenthiran, S, Schulze, PC, Jacobshagen, C, Frank, D, Baldus, S, Lehmann, R, Spies, C, Klein, N, Eitel, I, Zahn, R, Schmeisser, A, Gori, T, Lurz, P, Akin, I, Chatzis, G, Rizas, K, Kessler, T, Ademaj, F & Thiele, H 2025, 'Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial', American heart journal, bind 287, s. 94-106. https://doi.org/10.1016/j.ahj.2025.04.007

Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial. / COMPLETE-NSTEMI Investigators; Feistritzer, Hans-Josef; Jobs, Alexander et al.
I: American heart journal, Bind 287, 08.04.2025, s. 94-106.

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

TY - JOUR

T1 - Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial

T2 - The COMPLETE-NSTEMI trial

AU - COMPLETE-NSTEMI Investigators

AU - Feistritzer, Hans-Josef

AU - Jobs, Alexander

AU - Zeymer, Uwe

AU - Schneider, Steffen

AU - Lauten, Philipp

AU - Ferenc, Miroslaw

AU - Weferling, Maren

AU - Brinkmann, Regine

AU - Winkler, Sebastian

AU - Landmesser, Ulf

AU - Trippel, Tobias

AU - Stellbrink, Christoph

AU - Wienbergen, Harm

AU - Fürnau, Georg

AU - Möllmann, Helge

AU - Linke, Axel

AU - Jung, Christian

AU - Lauten, Alexander

AU - Achenbach, Stephan

AU - Rassaf, Tienush

AU - Schmitz, Thomas

AU - Cremer, Sebastian

AU - Olivier, Christoph

AU - Schächinger, Volker

AU - Sossalla, Samuel

AU - Toischer, Karl

AU - Templin, Christian

AU - Sedding, Daniel

AU - Clemmensen, Peter

AU - Tigges, Eike

AU - Meincke, Felix

AU - Sharar, Haitham Abu

AU - Kulenthiran, Saarraaken

AU - Schulze, P Christian

AU - Jacobshagen, Claudius

AU - Frank, Derk

AU - Baldus, Stephan

AU - Lehmann, Ralf

AU - Spies, Christian

AU - Klein, Norbert

AU - Eitel, Ingo

AU - Zahn, Ralf

AU - Schmeisser, Alexander

AU - Gori, Tommaso

AU - Lurz, Philipp

AU - Akin, Ibrahim

AU - Chatzis, Georgios

AU - Rizas, Konstantinos

AU - Kessler, Thorsten

AU - Ademaj, Fadil

AU - Thiele, Holger

PY - 2025/4/8

Y1 - 2025/4/8

N2 - BACKGROUND: Multivessel coronary artery disease (CAD) is present in 30-70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population.PRIMARY HYPOTHESIS: The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD.DESIGN: COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI.ENDPOINTS: The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for non-fatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached.CURRENT STATUS: The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028.OUTLOOK: COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD.TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT05786131.

AB - BACKGROUND: Multivessel coronary artery disease (CAD) is present in 30-70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population.PRIMARY HYPOTHESIS: The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD.DESIGN: COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI.ENDPOINTS: The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for non-fatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached.CURRENT STATUS: The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028.OUTLOOK: COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD.TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT05786131.

U2 - 10.1016/j.ahj.2025.04.007

DO - 10.1016/j.ahj.2025.04.007

M3 - Article

C2 - 40209841

SN - 0002-8703

VL - 287

SP - 94

EP - 106

JO - American heart journal

JF - American heart journal

ER -

COMPLETE-NSTEMI Investigators, Feistritzer HJ, Jobs A, Zeymer U, Schneider S, Lauten P et al. Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial. American heart journal. 2025 apr. 8;287:94-106. Epub 2025 apr. 8. doi: 10.1016/j.ahj.2025.04.007

Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial: The COMPLETE-NSTEMI trial

Abstract

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