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In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.
The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well.
The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention.
In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization
To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization.
Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative | No Intervention | After the index primary PCI. The control group will receive best medical therapy and regular follow up and only PCI for recurrent angina with evidence of inducible ischaemia. | |
| FFR guided | Active Comparator | FFR group will undergo FFR at 4 weeks of the index primary PCI as OPD. If FFR is less than 0.8, then PCI will be performed |
|
| angiogram guided | Active Comparator | The group will undergo PCI for all significant lesions more than 50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR guided PCI | Procedure | Patients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of cardiovascular death, myocardial infarction and / or revascularization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular morality | 1 year | |
| Myocardial infarction | 1 year | |
| Revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | any major bleeding (TIMI 3) | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas J Kiernan, MD | Contact | +35361482684 | tom_kiernan@hotmail.com | |
| Abdullah S Abdullah, MBBS, MRCPI, MSc | Contact | ++35361482684 | abdalasayid@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas J Kiernan, MD | University Hospital of Limerick | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galway University Hospital | Galway | Galway | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25766941 | Background | Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038. | |
| 26498666 |
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| Angio guided PCI | Procedure | Patients receive PCI without FFR measurement |
|
Revascularization procedure because of symptoms and evidence of ischaemia
| 1 year |
| stroke | 1 year |
| Heart failure | documented episode of presentation with symptoms consistent with heart failure and evidence from echocardiogram or laboratory test consistent with the diagnosis of heart failure | 1 year |
| Costs | total procedural costs, hospital stay costs, medications costs. | 1 year |
| University Hospital Limerick | Limerick | Limerick | 000 | Ireland |
|
| Result |
| Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available. |
| 26347918 | Result | Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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