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| ID | Type | Description | Link |
|---|---|---|---|
| 28708 | Other Identifier | NTR |
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| Name | Class |
|---|---|
| Maastricht University Medical Center | OTHER |
| Radboud University Medical Center | OTHER |
| Jeroen Bosch Ziekenhuis | OTHER |
| VieCuri Medical Centre |
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To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.
Background:
Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD.
Objective:
To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.
Design:
Prospective, multicentre, 1:1 randomized, investigator initiated study.
Hypothesis:
FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemia driven revascularization | Experimental | In the ischemia driven complete revascularisation strategy 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. |
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| Usual care group | Active Comparator | In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ischemia driven revascularization | Procedure | In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of MACE at 12 months | MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of MACE in subgroups at 12 and 24 months. | Prespecified subgroup analyses of primary outcomes will be performed for:
The Global Registry of Acute Coronary Events (GRACE) score estimates the admission 6 month mortality for patients with acute coronary syndrome. The GRACE score ranges from 0 to > 285. A higher GRACE represents a higher mortality risk, ranging from 0-2% when the GRACE is between 0 and 87, to 99% when the GRACE exceeds 285. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saman Rasoul, Dr. | Zuyderland MC | Principal Investigator |
| Arnoud van 't Hof, Prof. Dr. | Zuyderland MC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno University Hospital | Brno | Czechia | ||||
| Gottsegen György Országos Kardiológiai Intézet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40886310 | Derived | Pustjens TFS, Veenstra L, Camaro C, Ruiters AW, Lux A, Ruzsa Z, Piroth Z, Ilhan M, Vainer J, Gho B, Winkler PJC, Stein M, Theunissen RALJ, Kala P, Polad J, Berta B, Gabrio A, van Royen N, van 't Hof AWJ, Rasoul S. Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial. JAMA. 2025 Nov 11;334(18):1628-1637. doi: 10.1001/jama.2025.16189. |
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| OTHER |
| Gottsegen György Országos Kardiológiai Intézet | UNKNOWN |
| Bács-Kiskun County Teaching Hospital | OTHER |
| Brno University Hospital | OTHER |
| Szeged University | OTHER |
It concerns an investigator initiated prospective 1:1 randomised clinical trial in non-STEMI patients with multivessel coronary artery disease amenable to treatment with PCI.
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| Usual care group | Other | In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure. |
|
| 12 and 24 months |
| Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months. | 12, 24 and 36 months |
| Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months. | 12, 24 and 36 months |
| All-cause mortality or Myocardial infarction at 12, 24 and 36 months. | 12, 24 and 36 months |
| Any revascularisation at 12, 24 and 36 months. | 12, 24 and 36 months |
| Stent thrombosis at 12, 24 and 36 months. | 12, 24 and 36 months |
| Bleeding (major and minor) at 48 hours and 12 months. | 48 hours and 12 months |
| The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months. | MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months. | 12, 24 and 36 months |
| Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography). | 12, 24 and 36 months |
| Budapest |
| Hungary |
| Bacs-Kiskun Teaching Hospital | Kecskemét | Hungary |
| Szeged University | Szeged | Hungary |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands |
| Zuyderland MC | Heerlen | Netherlands |
| Maastricht University Medical Centre | Maastricht | Netherlands |
| Radboud University Medical Centre | Nijmegen | Netherlands |
| Viecuri Medisch Centrum | Venlo | Netherlands |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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