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

Myocardial Infarction Clinical Trial

— CompareAcute  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399736
• Other study ID #: Compare-Acute
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2020
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 885
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Multivessel Coronary Artery Disease
• Myocardial Infarction

Intervention

Procedure:
• FFR-guided revascularisation strategy
FFR-guided revascularisation strategy
• randomised to guidelines group
Staged revascularisation by proven ischemia or persistence of symptoms of angina

Locations

Country	Name	City	State
Czechia	University Hospital BRNO	Brno
Czechia	University Hospital Hradec Králové	Hradec Králové
Czechia	Liberec Regional Hospital	Liberec
Germany	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
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
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	Medisch Centrum Haaglanden	The Hague
Norway	Oslo University Hospital	Oslo
Poland	Miedziowe Centrum Zdrowia Lubin	Lubin
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw
Poland	Kliniki Kardiologii Allenort	Warsaw
Poland	4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ	Wroclaw
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Sweden	Sahlgrenska Götheborg University Hospital	Goteborg

Sponsors (2)

Lead Sponsor	Collaborator
Maasstad Hospital	Abbott Medical Devices

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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;	FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients),	3 year
Other	Comparison of Acute Versus Staged PCI for Lesions With FFR = 0.80	Comparison of acute versus staged PCI treatment for lesions with FFR	3 year
Other	Comparison of PCI vs Medical Therapy in FFR Negative Lesions	comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA	3 year
Primary	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
Primary	Number of Participants With Death From Any Cause	Number of participants with all cause mortality at 12 months between groups	12 months
Primary	Number of Participants With Cardiac Death	Number of participants with Cardiac mortality at 12 months between groups	12 months
Primary	Number of Participants With Spontaneous MI	Number of participants with Spontaneous Myocardial Infarction at 12 months between groups	12 months
Primary	Number of Participants With Periprocedural MI	Number of participants with Periprocedural Myocardial Infarction at 12 months between groups	12 months
Primary	Number of Participants With Revascularization - PCI	Number of participants with revascularization PCI at 12 months between groups	12 months
Primary	Number of Participants With Revascularization - CABG	Number of participants with revascularization CABG at 12 months between groups	12 months
Primary	Number of Participants With Cerebrovascular Event	Number of participants with Cerebrovascular event at 12 months between groups	12 months
Secondary	Number of Participants With Composite Endpoint of NACE (Any First Event)	Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)	12 months
Secondary	Number of Participants With Death From Any Cause or MI	Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months	12 months
Secondary	Number of Participants With Major Bleeding	Number of participants with Major bleeding at 12 months - Part of composite NACE	12 months
Secondary	Number of Participants With Any Bleeding at 12 Months	Number of participants with any bleeding at 12 months - part of composite endpoint NACE	12 months
Secondary	Number of Participants With Any Bleeding at 48 Hours	Number of participants with any bleeding at 48 hours - part of composite endpoint NACE	48 hours
Secondary	Number of Participants With Hospitalization	Number of participants with hospitalization for heart failure, unstable angina or chest pain	12 months
Secondary	Number of Participants With Revascularization	Number of participants with any revascularization-Part of composite endpoint NACE	12 months
Secondary	Number of Participants With Stent Thrombosis	Number of participants with Stent Thrombosis - Part of composite endpoint NACE	12 months
Secondary	Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year	Number of participants with Composite primary endpoint MACCE (any first event) at 3 year	3 year
Secondary	Number of Participants With All Cause Death at 3 Year	Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death	3 year
Secondary	Number of Participants With Cardiac Death at 3 Year	Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death	3 year
Secondary	Number of Participants With Spontaneous MI at 3 Year	Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI	3 year
Secondary	Number of Participants With Peri-procedural MI at 3 Year	Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI	3 year
Secondary	Number of Participants With Urgent Revascularization at 3 Year	Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation	3 year
Secondary	Number of Participants With Elective Revascularization at 3 Year	Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation	3 year
Secondary	Number of Participants With Cerebrovascular Event	Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event	3 year
Secondary	Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year	Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events)	3 years
Secondary	Number of Participants With Death From Any Cause or MI	Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year	3 year
Secondary	Number of Participants With Major Bleeding at 3 Year	Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year	3 year
Secondary	Number of Participants With Hospitalization	Number of participants with Hospitalization for heart failure, unstable angina, MI	3 year
Secondary	Number of Participants With Hospitalization at 3 Year	Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain	3 year
Secondary	Number of Participants With Stent Thrombosis at 3 Year	Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE	3 year
Secondary	Number of Participants With Any Bleeding at 3 Year	Number of participants with any bleeding at 3 year - Part of composite endpoint NACE	3 year