N/A
N=885
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
Myocardial Infarction · Multivessel Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01399736 ↗Enrolled (actual)
885
Serious AEs
45.2%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With the Composite Endpoint of MACCE — 23; 121 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FFR-guided revascularisation strategy (Procedure); randomised to guidelines group (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Maasstad Hospital
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Composite Endpoint of MACCE |
23; 121 | <0.001 sig |
| PRIMARY Number of Participants With Death From Any Cause |
4; 10 | 0.70 |
| PRIMARY Number of Participants With Cardiac Death |
3; 6 | 1.00 |
| PRIMARY Number of Participants With Spontaneous MI |
5; 17 | 0.10 |
| PRIMARY Number of Participants With Periprocedural MI |
2; 11 | 0.29 |
| PRIMARY Number of Participants With Revascularization - PCI |
15; 98 | <0.001 sig |
| PRIMARY Number of Participants With Revascularization - CABG |
3; 5 | 0.80 |
| PRIMARY Number of Participants With Cerebrovascular Event |
1; 7 | — |
| SECONDARY Number of Participants With Composite Endpoint of NACE (Any First Event) |
25; 174 | — |
| SECONDARY Number of Participants With Death From Any Cause or MI |
28; 73 | — |
| SECONDARY Number of Participants With Major Bleeding |
3; 8 | — |
| SECONDARY Number of Participants With Any Bleeding at 12 Months |
9; 28 | — |
| SECONDARY Number of Participants With Any Bleeding at 48 Hours |
5; 8 | — |
| SECONDARY Number of Participants With Hospitalization |
28; 75 | — |
| SECONDARY Number of Participants With Revascularization |
19; 161 | — |
| SECONDARY Number of Participants With Stent Thrombosis |
2; 1 | — |
| SECONDARY Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year |
46; 178 | — |
| SECONDARY Number of Participants With All Cause Death at 3 Year |
9; 21 | — |
| SECONDARY Number of Participants With Cardiac Death at 3 Year |
5; 8 | — |
| SECONDARY Number of Participants With Spontaneous MI at 3 Year |
17; 40 | — |
| SECONDARY Number of Participants With Peri-procedural MI at 3 Year |
3; 13 | — |
| SECONDARY Number of Participants With Urgent Revascularization at 3 Year |
22; 85 | — |
| SECONDARY Number of Participants With Elective Revascularization at 3 Year |
15; 64 | — |
| SECONDARY Number of Participants With Cerebrovascular Event |
1; 7 | — |
| SECONDARY Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year |
45; 215 | — |
| SECONDARY Number of Participants With Death From Any Cause or MI |
28; 73 | — |
| SECONDARY Number of Participants With Major Bleeding at 3 Year |
3; 8 | — |
| SECONDARY Number of Participants With Hospitalization |
28; 75 | — |
| SECONDARY Number of Participants With Hospitalization at 3 Year |
30; 87 | — |
| SECONDARY Number of Participants With Stent Thrombosis at 3 Year |
4; 12 | — |
| SECONDARY Number of Participants With Any Bleeding at 3 Year |
4; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in 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, 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01399736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.