Multivessel Coronary Artery Disease, Non-ST-elevation Myocardial Infarction
Conditions
Keywords
NSTEMI, Multivessel coronary artery disease, culprit-lesion only PCI, multivessel percutaneous coronary intervention
Brief summary
Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.
Detailed description
The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.
Interventions
PROCEDURECulprit-lesion revascularization
Percutaneous coronary intervention of culprit-lesion
PROCEDURENon-culprit-lesion revascularization
Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions
Sponsors
Heart Center Leipzig at University of Leipzig
German Federal Ministry of Education and Research
IHF GmbH - Institut für Herzinfarktforschung
Stiftung IHF - Institut für Herzinfarktforschung
Leipzig Heart Science gGmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* NSTEMI as suggested by high-sensitivity troponin algorithms * Multivessel coronary artery disease * Identifiable culprit lesion * Informed consent
Exclusion criteria
* Age \<18 years * Cardiogenic shock * Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) * Contraindication for coronary revascularization * Prior coronary artery bypass graft * Indication for coronary artery bypass graft surgery * Non-culprit lesion located in the left main coronary artery * Co-morbidity with life expectancy less than 6 months * Type 2 myocardial infarction * Pregnancy and breast feeding period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction | During follow-up (2 years estimated average duration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Rehospitalization for non-fatal myocardial infarction | During follow-up (2 years estimated average duration) | — |
| Rate of all-cause death | During follow-up (2 years estimated average duration) | — |
| Rate of ischemia-driven revascularization | During follow-up (2 years estimated average duration) | — |
| Rate of rehospitalization for heart failure | During follow-up (2 years estimated average duration) | — |
| Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization | During follow-up (2 years estimated average duration) | — |
| Rate of Cardiovascular death | During follow-up (2 years estimated average duration) | — |
| Quality of Life (EQ-5D-5L) | 12 months | European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome |
| Rate of bleeding | 6 months | — |
| Rate of stroke | 6 months | Ischemic and Hemorrhagic |
| Rate of contrast-induced acute kidney injury | 6 months | AKIN grade I-III |
| Rate of coronary procedure-related myocardial infarction | 6 months | — |
| Rate of coronary artery bypass surgery | During follow-up (2 years estimated average duration) | — |
Countries
Austria, Germany
Contacts
Primary ContactHolger Thiele, MD, Prof. Dr.
Backup ContactHans-Josef Feistritzer, MD, PhD; Assoc. Prof.
Outcome results
None listed