Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Multivessel Coronary Artery Disease |
Procedure: FFR-guided revascularisation strategy Procedure: randomised to guidelines group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Composite endpoint of MACCE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
- Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment.
- Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA
- Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA.
- Composite endpoint of NACE [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12, 24 and 36 months (NACE i.e. Net Adverse Clinical Events)
- Composite endpoint hospitalisation HF and UAP [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]A composite of hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months
- All cause mortality and MI [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]All cause mortality or Myocardial infarction at 12, 24 and 36 months
- Revascularisation [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]Any revascularisation at 12, 24 and 36 months
- Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]Stent thrombosis at 12, 24 and 36 months
- Bleeding [ Time Frame: 48 hour and 12 months ] [ Designated as safety issue: Yes ]Bleeding at 48 hr and 12 months
- Treatment costs [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]Treatment costs 12, 24 and 36 months
- Primary endpoint at 24 and 36 [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]Primary endpoint at 24 and 36 months as well as outcomes of each component of the primary endpoint at 12, 24 and 36 months.
| Estimated Enrollment: | 885 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: FFR-guided revascularisation strategy
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.
|
Procedure: FFR-guided revascularisation strategy
FFR-guided revascularisation strategy
|
|
Placebo Comparator: randomised to guidelines group
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).
|
Procedure: randomised to guidelines group
Staged revascularisation by proven ischemia or persistence of symptoms of angina
|
Detailed 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
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- Left main stem disease (stenosis > 50%)
- STEMI due to in-stent thrombosis
- Chronic total occlusion of a non-IRA
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
- Non-IRA stenosis not amenable for PCI treatment (operators decision)
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
- Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
- Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
- Life expectancy of < 2 years.
- Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
- Gastrointestinal or genitourinary bleeding within the prior 3 months,
- Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Pregnancy or planning to become pregnant any time after enrolment into this study.
- Inability to obtain informed consent.
- Expected lost to follow-up.
Contacts and Locations| Contact: Peter Smits, MD, PHD | +31102913322 | smitsp@maasstadziekenhuis.nl |
| Contact: Elvin Kedhi, MD, PHD | +31102913124 | KedhiE@maasstadziekenhuis.nl |
| Germany | |
| Herz-Zentrum Bad Krozingen | Not yet recruiting |
| Bad Krozingen, Germany, 79189 | |
| Principal Investigator: Franz-Josef Neumann, MD | |
| Herzzentrum Bad Segeberger Klinik | Recruiting |
| Bad Segeberg, Germany, 23795 | |
| Principal Investigator: Gert Richardt, MD | |
| Klinikum Links der Weser | Not yet recruiting |
| Bremen, Germany, 28277 | |
| Contact: Rainer Hambrecht, MD PHD | |
| Principal Investigator: Rainer Hambrecht, MD PHD | |
| Medizinische Klinik IV | Not yet recruiting |
| Ingolstadt, Germany, 85049 | |
| Contact: Karl Heinz Seidl, MD, PHD | |
| Principal Investigator: Karl Heinz Seidl, MD PHD | |
| Deutsches Herzzentrum München | Not yet recruiting |
| München, Germany, 80636 | |
| Principal Investigator: Julinda Mehilli, MD | |
| Medical University Rostock | Recruiting |
| Rostock, Germany, 18057 | |
| Principal Investigator: Christoph Nienaber, MD | |
| Luxembourg | |
| INCCI (Luxembourg Heart Institute) | Withdrawn |
| Luxembourg, Luxembourg | |
| Netherlands | |
| Academic Medical Center | Not yet recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Principal Investigator: J.P.S. Henriques, MD | |
| Maasstadhospital | Recruiting |
| Rotterdam, Netherlands, 3079DZ | |
| Principal Investigator: Peter Smits, MD, Phd | |
| Medisch Centrum Haaglanden | Recruiting |
| The Hague, Netherlands, 2512 VA | |
| Principal Investigator: P.V. Oemrawsing, MD | |
| Norway | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway | |
| Principal Investigator: Ketil Linde, MD, PhD | |
| Singapore | |
| Tan Tock Seng Hospital | Not yet recruiting |
| Singapore, Singapore, 308433 | |
| Contact: Paul Ong, MD | |
| Principal Investigator: Paul Ong, MD | |
| Khoo Teck Puat Hospital | Not yet recruiting |
| Singapore, Singapore, 768828 | |
| Contact: Brian Khoo, MD | |
| Principal Investigator: Brian Khoo, MD | |
| Sweden | |
| Sahlgrenska Götheborg University Hospital | Recruiting |
| Goteborg, Sweden, 41315 | |
| Principal Investigator: Elmir Omerovic, MD | |
| Principal Investigator: | Peter Smits, MD. PHD | Maastadhospital / MCR |
More Information
No publications provided
| Responsible Party: | Maasstad Hospital |
| ClinicalTrials.gov Identifier: | NCT01399736 History of Changes |
| Other Study ID Numbers: | Compare-Acute |
| Study First Received: | July 20, 2011 |
| Last Updated: | December 17, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Germany: Ethics Commission Sweden: Regional Ethical Review Board Luxembourg: Comite National d'Ethique de Recherche Norway: Regional Ethics Commitee Singapore: Domain Specific Review Boards |
Keywords provided by Maasstad Hospital:
|
PCI FFR STEMI MVD FFR guided PCI in acute STEMI patients with MVD |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on June 17, 2013