ACS (Acute Coronary Syndrome), Ischemic Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
OCT guided PCI, ACS undergoing PCI
Brief summary
The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS
Detailed description
Patients presenting with acute coronary syndrome (ACS) have worse short and mid-term prognosis compared with patients revascularized for chronic coronary syndrome. Angiographic assessment of patients with ACS is frequently limited by high ambiguity both in identification of culprit lesions, characterization of non-culprit lesions, and in identification of suboptimal treatment results. Intravascular imaging may improve diagnosis and allow for better treatment optimization during coronary intervention of patients with ACS. The large-scale Chinese IVUS-ACS trial showed a 50% reduction in one-year MACE with IVUS-guided PCI in patients with ACS whereas a number of small studies on routine OCT guiding as well as ACS subgroups in RCTs did not indicate a potential similar benefit with OCT. OCT assessment has several theoretical advantages over IVUS in patients with ACS indicating the need for a well-designed strategy trial on OCT vs angiographic guided PCI. Hypothesis: Routine OCT-guided diagnosis and revascularization yields superior one-year clinical outcome compared with standard angiography-guided diagnosis and revascularization in patients with acute coronary syndrome Methods: Investigator initiated, open label, prospective, 1:1 randomized, multi-center, clinical outcome, superiority trial. Primary Endpoint: Major adverse cardiac events (MACE) comprising all-cause death, spontaneous myocardial infarction and stroke.
Interventions
PROCEDUREAngiographic Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
PROCEDUREOCT Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Sponsors
Aarhus University Hospital Skejby
Abbott
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
Clinical inclusion criteria: * NSTEMI, STEMI * Symptom duration \<12h for STEMI and \<48h for NSTEMI * Age ≥ 18yrs * Ability to provide written informed consent Angiographic inclusion criteria: * Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis * Wire in true distal lumen
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined endpoint of major adverse cardiac events (MACE) | 12 months | Comprising all-cause death, spontaneous myocardial infarction and stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined endpoint of major adverse cardiac events (MACE) | 30 days, 36 months and 60 months | Comprising all-cause death, spontaneous myocardial infarction and stroke |
| Patient-oriented composite (PoCE) MACE endpoint | 30 days, 12 months, 36 months and 60 months | Comprising all cause death, any myocardial infarction, any unplanned revascularization and stroke |
| All-cause mortality | 30 days, 12 months, 36 months, 60 months and 10 years | All-cause mortality includes death of any cause including cardiac deaths and non-natural causes of deaths |
| Cardiac death | 30 days, 12 months, 36 months and 60 months | Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death. |
| Spontaneous myocardial infarction | 30 days, 12 months, 36 months and 60 months | Following 4th universal MI definition |
| Any ischemia-driven revascularization | 30 days, 12 months, 36 months and 60 months | Any repeat iscemia-driven revascularization (coronary artery bypass grafting or PCI) except staged revascularization planned during the index procedure |
| Any unplanned revascularization | 30 days, 12 months, 36 months and 60 months | Any unplanned repeat revascularization |
| Ischemia-driven target lesion revascularization | 30 days, 12 months, 36 months and 60 months | Any non-staged repeat ischemia-driven revascularization (coronary artery bypass grafting or PCI) of any lesion treated at the index admission |
| Ischemia-driven target vessel revascularization | 30 days, 12 months, 36 months and 60 months | Any non-staged repeat ischemia-driven revascularization (coronary artery bypass grafting or PCI) of any vessel treated at the index admission |
| Target lesion revascularization | 30 days, 12 months, 36 months and 60 months | Any non-staged repeat revascularization (coronary artery bypass grafting or PCI) of any lesion treated at the index admission |
| Target vessel revascularization | 30 days, 12 months, 36 months and 60 months | Any non-staged repeat revascularization (coronary artery bypass grafting or PCI) of any vessel treated at the index admission |
| Stroke | 30 days, 12 months, 36 months and 60 months | Acute neurological deficit of cerebrovascular cause that persists beyond 24 hours with CT or MRI confirmation |
| Rose dyspnea Scale | 30 days, 12 months, 36 months and 60 months | Assesses the severity of dyspnea during specific physical activities, ranging from 0-4. Higher scores indicate worse dyspnea |
| CCS-angina class | 30 days, 12 months, 36 months and 60 months | 4-level grading system to categorizes stable angina symptoms based on the severity of physical limitations |
| Peri-procedure related MI | During or within 48 hours after the procedure (index or staged within the same admission) | According to the ARC-2 and 4th universal definition criterias |
| Stent thrombosis | 30 days, 12 months, 36 months and 60 months | Definite, probable or possible in time categories: acute, subacute, late and very late (ARC-2 definitions) |
| Contrast induced nephropathy | 48h | Defined as a \>50% increase in plasma creatinine after the procedure within the first 48 hours |
Countries
Belgium, Denmark, Estonia, Finland, Italy, Latvia, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom
Contacts
STUDY_CHAIREvald H Christiansen, Prof.MD.PhD
Aarhus University Hospital
Outcome results
None listed