coronary artery disease
Conditions
Interventions
Patients will be enrolled and randomised in a 1:1 fashion between the ischemia driven (FFR) revascularisation strategy, versus usual care, after completion of a successful culprit lesion PCI. All pati
2.0 mm and fulfil the inclusion and exclusion criteria will be enrolled.
Sponsors
Zuyderland Medical Centre, Heerlen, The Netherlands
and
Maastricht University Medical Centre +, Maastricht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: • Patients aged between 18-85 years presenting with non-STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator. • Non-IRA stenosis amenable for PCI treatment (operator’s decision) • Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Left main disease (stenosis > 50%) 2. Chronic total occlusion of a non-IRA 3. Indication for or previous coronary artery bypass grafting 4. Uncertain culprit lesion 5. Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRA treatment (TIMI flow 0-1) and inability to implant a stent 6. Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period. 7. Killip class III or IV during the completion of culprit lesion treatment. 8. Life expectancy of < 1 year. 9. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor or Heparin. 10. Gastrointestinal or genitourinary bleeding within the prior 3 months. 11. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment. 12. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 13. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoints are defined as the incidence of MACE (Composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke) at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Primary endpoint in subgroups at 12 and 24 months in the subgroup of patients. • Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months. • Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months. • All-cause mortality or Myocardial infarction at 12, 24 and 36 months.. • Any revascularisation at 12, 24 and 36 months. • Stent thrombosis at 12, 24 and 36 months. • Bleeding (major and minor) at 48 hr and 12 months • Primary endpoint at 36 months as well as outcomes of each component of the primary endpoint at 12 and 24 and 36 months. • Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography) | — |
Contacts
Public ContactTobias Pustjens
Outcome results
None listed