Overview

This trial is active, not recruiting.

Conditions myocardial infarction, multivessel coronary artery disease
Treatments ffr-guided revascularisation strategy, randomised to guidelines group
Phase phase 4
Sponsor Maasstad Hospital
Collaborator Abbott Vascular
Start date July 2011
End date November 2016
Trial size 885 participants
Trial identifier NCT01399736, Compare-Acute

Summary

The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.

Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.

Approximately 885 patients will be entered in the study.

Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.
ffr-guided revascularisation strategy
FFR-guided revascularisation strategy
(Placebo Comparator)
In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).
randomised to guidelines group
Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary Outcomes

Measure
Composite endpoint of MACCE
time frame: 12 months

Secondary Outcomes

Measure
Primary endpoint in subgroups
time frame: 12, 24 and 36 months
Primary endpoint in subgroups
time frame: 12, 24 and 36 months
Primary endpoint in subgroups
time frame: 12, 24 and 36 months
Composite endpoint of NACE
time frame: 12, 24 and 36 months
Composite endpoint hospitalisation HF and UAP
time frame: 12, 24 and 36 months
All cause mortality and MI
time frame: 12, 24 and 36 months
Revascularisation
time frame: 12, 24 and 36 months
Stent thrombosis
time frame: 12, 24 and 36 months
Bleeding
time frame: 48 hour and 12 months
Treatment costs
time frame: 12, 24 and 36 months
Primary endpoint at 24 and 36
time frame: 12, 24 and 36 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* 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. - Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised Exclusion Criteria: 1. Left main stem disease (stenosis > 50%) 2. STEMI due to in-stent thrombosis 3. Chronic total occlusion of a non-IRA 4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery. 5. Non-IRA stenosis not amenable for PCI treatment (operators decision) 6. Complicated IRA treatment, with one or more of the following; - Extravasation, - Permanent no re-flow after IRA treatment (TIMI flow 0-1), - Inability to implant a stent 7. Known severe cardiac valve dysfunction that will require surgery in the follow-up period. 8. Killip class III or IV already at presentation or at the completion of culprit lesion treatment. 9. Life expectancy of < 2 years. 10. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy. 11. Gastrointestinal or genitourinary bleeding within the prior 3 months, 12. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment. 13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 14. Pregnancy or planning to become pregnant any time after enrolment into this study. 15. Inability to obtain informed consent. 16. Expected lost to follow-up.

Additional Information

Official title Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
Principal investigator Peter Smits, MD. PHD
Description Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques. Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2) Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI. Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Maasstad Hospital.