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

NCT ID: NCT01399736

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 885 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2018-10-31

Brief 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.

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

Conditions

Myocardial Infarction; Multivessel Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

FFR-guided revascularisation strategy

Intervention Type: PROCEDURE

FFR-guided revascularisation strategy

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).

Group Type: PLACEBO_COMPARATOR

randomised to guidelines group

Intervention Type: PROCEDURE

Staged revascularisation by proven ischemia or persistence of symptoms of angina

Interventions

FFR-guided revascularisation strategy

FFR-guided revascularisation strategy

Intervention Type: PROCEDURE

randomised to guidelines group

Staged revascularisation by proven ischemia or persistence of symptoms of angina

Intervention Type: PROCEDURE

Eligibility 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, Prasugrel, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Smits, MD. PHD

Role: PRINCIPAL_INVESTIGATOR

Maastadhospital / MCR

Elmir Omerovic, MD PhD

Role: STUDY_CHAIR

Sahlgrenska Hospital Götheborg

Gert Richardt, MD PhD

Role: STUDY_CHAIR

Herzzentrum Segeberger Kliniken

Franz-Josef Neumann, MD PhD

Role: STUDY_CHAIR

Herz-Zentrum Bad Krozingen

Locations

University Hospital BRNO

Brno, , Czechia

University Hospital Hradec Králové

Hradec Králové, , Czechia

Liberec Regional Hospital

Liberec, , Czechia

Herz-Zentrum Bad Krozingen

Bad Krozingen, , Germany

Herzzentrum Bad Segeberger Klinik

Bad Segeberg, , Germany

Klinikum Links der Weser

Bremen, , Germany

Medizinische Klinik IV

Ingolstadt, , Germany

Medical University Rostock

Rostock, , Germany

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

Rijnstate Hospital

Arnhem, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

Atrium MC Parkstad

Heerlen, , Netherlands

Maastricht Universitair Medical center

Maastricht, , Netherlands

Maasstadhospital

Rotterdam, , Netherlands

Medisch Centrum Haaglanden

The Hague, , Netherlands

Oslo University Hospital

Oslo, , Norway

Miedziowe Centrum Zdrowia Lubin

Lubin, , Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Kliniki Kardiologii Allenort

Warsaw, , Poland

4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Wroclaw, , Poland

Tan Tock Seng Hospital

Singapore, , Singapore

Khoo Teck Puat Hospital

Singapore, , Singapore

Sahlgrenska Götheborg University Hospital

Gothenburg, , Sweden

Countries

Czechia; Germany; Hungary; Netherlands; Norway; Poland; Singapore; Sweden

References

Piroth Z, Fulop G, Boxma-de Klerk BM, Abdelghani M, Omerovic E, Andreka P, Fontos G, Neumann FJ, Richardt G, Smits PC. Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010796. doi: 10.1161/CIRCINTERVENTIONS.121.010796. Epub 2022 Jan 20.

Reference Type: DERIVED

PMID: 35045732 (View on PubMed)

Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.

Reference Type: DERIVED

PMID: 30823897 (View on PubMed)

Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.

Reference Type: DERIVED

PMID: 28317428 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Compare-Acute

Identifier Type: -

Identifier Source: org_study_id