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

NCT01399736 | Completed Results DMC

• 1 other identifier: Compare-Acute
• Study Type: interventional
• Target: 885
• Locations: 8 countries
• Sites: 26

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.

Conditions

Myocardial Infarction; Multivessel Coronary Artery Disease

Keywords

PCI FFR STEMI MVD; FFR guided PCI in acute STEMI patients with MVD

Outcome Measures

Primary Outcomes (8)

• Number of Participants With the Composite Endpoint of MACCE

  Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups

  12 months

• Number of Participants With Death From Any Cause

  Number of participants with all cause mortality at 12 months between groups

  12 months

• Number of Participants With Cardiac Death

  Number of participants with Cardiac mortality at 12 months between groups

  12 months

• Number of Participants With Spontaneous MI

  Number of participants with Spontaneous Myocardial Infarction at 12 months between groups

  12 months

• Number of Participants With Periprocedural MI

  Number of participants with Periprocedural Myocardial Infarction at 12 months between groups

  12 months

• Number of Participants With Revascularization - PCI

  Number of participants with revascularization PCI at 12 months between groups

  12 months

• Number of Participants With Revascularization - CABG

  Number of participants with revascularization CABG at 12 months between groups

  12 months

• Number of Participants With Cerebrovascular Event

  Number of participants with Cerebrovascular event at 12 months between groups

  12 months

Secondary Outcomes (23)

• Number of Participants With Composite Endpoint of NACE (Any First Event)

  12 months

• Number of Participants With Death From Any Cause or MI

  12 months

• Number of Participants With Major Bleeding

  12 months

• Number of Participants With Any Bleeding at 12 Months

  12 months

• Number of Participants With Any Bleeding at 48 Hours

  48 hours

Other Outcomes (3)

• A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80;

  3 year

• Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80

  3 year

• Comparison of PCI vs Medical Therapy in FFR Negative Lesions

  3 year

Study Arms (2)

FFR-guided revascularisation strategy

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.

Procedure: FFR-guided revascularisation strategy

randomised to guidelines group

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).

Procedure: randomised to guidelines group

Interventions

FFR-guided revascularisation strategy PROCEDURE

FFR-guided revascularisation strategy

FFR-guided revascularisation strategy

randomised to guidelines group PROCEDURE

Staged revascularisation by proven ischemia or persistence of symptoms of angina

randomised to guidelines group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, Prasugrel, 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.

Sponsors & Collaborators

• Maasstad Hospital: lead
• Abbott Medical Devices: collaborator

Study Sites (26)

University Hospital BRNO

Brno, Czechia

Location

University Hospital Hradec Králové

Hradec Králové, Czechia

Location

Liberec Regional Hospital

Liberec, Czechia

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herzzentrum Bad Segeberger Klinik

Bad Segeberg, 23795, Germany

Location

Klinikum Links der Weser

Bremen, 28277, Germany

Location

Medizinische Klinik IV

Ingolstadt, 85049, Germany

Location

Medical University Rostock

Rostock, 18057, Germany

Location

Gottsegen György Országos Kardiológiai Intézet

Budapest, Hungary

Location

Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital

Nyíregyháza, Hungary

Location

Szent-Györgyi Albert Klinika

Szeged, Hungary

Location

Zala Megyei Korhaz

Zalaegerszeg, Hungary

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Atrium MC Parkstad

Heerlen, Netherlands

Location

Maastricht Universitair Medical center

Maastricht, Netherlands

Location

Maasstadhospital

Rotterdam, 3079DZ, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, 2512 VA, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Miedziowe Centrum Zdrowia Lubin

Lubin, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Poland

Location

Kliniki Kardiologii Allenort

Warsaw, Poland

Location

4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Wroclaw, Poland

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Sahlgrenska Götheborg University Hospital

Gothenburg, 41315, Sweden

Location

Related Publications (3)

• 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.

  PMID: 35045732 DERIVED

• 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.

  PMID: 30823897 DERIVED

• 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.

  PMID: 28317428 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Dr.Pieter Smits
• Organization: Maasstad Hospital

SmitsP@maasstadziekenhuis.nl

+31102913322

Study Officials

• Peter Smits, MD. PHD

  Maastadhospital / MCR

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2018
• Last Updated: August 11, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); NO (1); DE (5); HU (4); CZ (3); NL (6); PL (4); SE (1)