Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott Vascular
St. Jude Medical
Information provided by (Responsible Party):
Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01399736
First received: July 20, 2011
Last updated: October 2, 2015
Last verified: October 2015
  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

Resource links provided by NLM:


Further study details as provided by Maasstad Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: November 2018
Estimated Primary Completion Date: November 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399736

Locations
Czech Republic
University Hospital BRNO
Brno, Czech Republic
University Hospital Hradec Králové
Hradec Králové, Czech Republic
Liberic Regional Hospital
Liberic, Czech Republic
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Herzzentrum Bad Segeberger Klinik
Bad Segeberg, Germany, 23795
Klinikum Links der Weser
Bremen, Germany, 28277
Medizinische Klinik IV
Ingolstadt, Germany, 85049
Medical University Rostock
Rostock, Germany, 18057
Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital
Nyíregyháza, Hungary
Szent-Györgyi Albert Klinika
Szeged, Hungary
Zala Megyei Korhaz
Zalaegerszeg, Hungary
Netherlands
Rijnstate Hospital
Arnhem, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Atrium MC Parkstad
Heerlen, Netherlands
Maastricht Universitair Medical center
Maastricht, Netherlands
Maasstadhospital
Rotterdam, Netherlands, 3079DZ
Medisch Centrum Haaglanden
The Hague, Netherlands, 2512 VA
Norway
Oslo University Hospital
Oslo, Norway
Poland
Miedziowe Centrum Zdrowia Lubin
Lubin, Poland
Kliniki Kardiologii Allenort
Warsaw, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Poland
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Poland
Singapore
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Khoo Teck Puat Hospital
Singapore, Singapore, 768828
Sweden
Sahlgrenska Götheborg University Hospital
Goteborg, Sweden, 41315
Sponsors and Collaborators
Maasstad Hospital
Abbott Vascular
St. Jude Medical
Investigators
Principal Investigator: Peter Smits, MD. PHD Maastadhospital / MCR
Study Chair: Elmir Omerovic, MD PhD Sahlgrenska Hospital Götheborg
Study Chair: Gert Richardt, MD PhD Herzzentrum Segeberger Kliniken
Study Chair: Franz-Josef Neumann, MD PhD Herz-Zentrum Bad Krozingen
  More Information

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: October 2, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission
Sweden: Regional Ethical Review Board
Norway: Regional Ethics Commitee
Singapore: Domain Specific Review Boards
Poland: Ethics Committee
Czech Republic: Ethics Committee
Hungary: Research Ethics Medical Committee

Keywords provided by Maasstad Hospital:
PCI FFR STEMI MVD
FFR guided PCI in acute STEMI patients with MVD

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 27, 2016