Follow up of Clinical Outcome of Deferred vs Immediate Stenting in High Thrombus Stemi Patients

STEMI Clinical Trial

Official title:

Short Term Clinical and Major Cardiovascular Adverse Events of Deferred Versus Immediate Stenting in High Thrombus Burden STEMI Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05793671
• Other study ID #: Deferred stenting in STEMI
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Andro Thabet Fawzy, Bachelor
• Phone: +201200012699
• Email: Thabetandro70[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of immediate stenting versus deferred stenting - with use of glycoproteinIIbIIIa inhibitor & low molecular weight heparin - on the clinical outcome -3 and 6 months after stenting & also infarct size using troponin level during hospital stay .

Clinical outcome - 3 and 6 months - after stenting which includes re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting , Congestive heart failure, cardiac death & cerebrovascular accidents.

Description:

Myocardial infarct¬¬¬ion is myocardial necrosis associated with impaired blood perfusion . Until now primary percutaneous coronary intervention (PPCI) is the standard modality of myocardial reperfusion However, there are a considerable number of patients whom still had acute reduction in myocardial blood perfusion after stent implantation even with patent epicardial artery which was defined as "no-reflow" That was explained by the affection of the micro-vasculature. With manipulation of culprit coronary artery lesion, distal embolization can occur, causing micro-vascular embolization & spasm which will significantly affect myocardial perfusion even with patent epicardial coronary artery Multiple methods were tried to decrease the chances of "no reflow phenomenon". Distal protection devices were used, but unfortunately with no promising results Routine thrombectomy is still controversial.

Deferred stenting, there is still controversy about the use of this strategy. At some studies, immediate stenting in thrombotic context was associated with no-reflow &distal embolization So ideas about deferred stenting started to glow when Isaac et al tried stenting deferral, after restoring culprit coronary artery patency using minimalist immediate mechanical intervention known as "MIMI - minimalist immediate mechanical intervention -" . That gave green light for further studies to explore benefits and risks of deferred stenting.

However , the strategy is still controversial , as some studies support the use of deferred stenting strategy and found it associated with better endpoints as, reduced no reflow , better myocardial perfusion and salvage lower major adverse cardiovascular events (MACE) , better left ventricular function

However there were other studies which showed no beneficial effect of deferred stenting, but even affect badly the micro-vascular obstruction. Reasons for these conflicting results included:

• Category of patients included where deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI) enrolled patients at high risk of slow flow based on clinical angiographic features, whereas DANAMI-3 DEFER was all-corner primary PCI study. A deferral strategy should only be applied after careful angiographic selection.

• DEFER-STEMI was angiographic and MRI end-point study whereas DANAMI 3-DEFER looked at clinical outcomes.

• DANAMI 3-DEFER was a larger multi-center randomized study in contrast to DEFER-STEMI.

• The use of GPIIbIIIa inhibitors in Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER) was significantly lower compared to DEFERED-STEMI.

• There was high crossover to immediate stenting in the defer arm of DANAMI trial which further weakened the results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary percutaneous coronary intervention (PPCI) patients with culprit vessels shows heavy thrombus burden lesions.

• Culprit vessels with TIMI 2-3 either from the beginning or after MIMI (Minimalist immediate mechanical intervention).

Exclusion Criteria:

• PPCI patients with low thrombus burden lesions.

• PPCI patient with heavy thrombus burden lesions but with culprit vessels TIMI score 0-1, didn't improve after MIMI.

• patients killip II /III /IV

Related Conditions & MeSH terms

• ST Elevation Myocardial Infarction
• STEMI
• Thrombosis

Intervention

Device:
• PPCI in heavy thrombus burden STEMI patients
minimally invasive procedures used to open clogged coronary arteries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (15)

Alidoosti M, Lotfi R, Lotfi-Tokaldany M, Nematipour E, Salarifar M, Poorhosseini H, Jalali A. Correlates of the "No-Reflow" or "Slow-Flow" Phenomenon in Patients Undergoing Primary Percutaneous Coronary Intervention. J Tehran Heart Cent. 2018 Jul;13(3):108-114. — View Citation

Belle L, Motreff P, Mangin L, Range G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388. — View Citation

Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27. — View Citation

Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7. doi: 10.1053/euhj.2001.3035. — View Citation

Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9. doi: 10.1097/00019501-200605000-00010. — View Citation

Jaffe R, Charron T, Puley G, Dick A, Strauss BH. Microvascular obstruction and the no-reflow phenomenon after percutaneous coronary intervention. Circulation. 2008 Jun 17;117(24):3152-6. doi: 10.1161/CIRCULATIONAHA.107.742312. No abstract available. — View Citation

Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, Kristensen J, Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF, Rasmussen K, Rehling M, Nielsen TT, Botker HE. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation. 2006 Jul 4;114(1):40-7. doi: 10.1161/CIRCULATIONAHA.105.595660. Epub 2006 Jun 26. — View Citation

Ke D, Zhong W, Fan L, Chen L. Delayed versus immediate stenting for the treatment of ST-elevation acute myocardial infarction with a high thrombus burden. Coron Artery Dis. 2012 Nov;23(7):497-506. doi: 10.1097/MCA.0b013e328358a5ad. — View Citation

Kelbaek H, Hofsten DE, Kober L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, De Backer O, Bang LE, Kofoed KF, Lonborg J, Ahtarovski K, Vejlstrup N, Botker HE, Terkelsen CJ, Christiansen EH, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Jensen LO, Clemmensen P, Grande P, Madsen JK, Torp-Pedersen C, Engstrom T. Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an open-label, randomised controlled trial. Lancet. 2016 May 28;387(10034):2199-206. doi: 10.1016/S0140-6736(16)30072-1. Epub 2016 Apr 3. — View Citation

Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047. — View Citation

Lim SY. No-Reflow Phoenomenon by Intracoronary Thrombus in Acute Myocardial Infarction. Chonnam Med J. 2016 Jan;52(1):38-44. doi: 10.4068/cmj.2016.52.1.38. Epub 2016 Jan 19. — View Citation

Pascal J, Veugeois A, Slama M, Rahal S, Belle L, Caussin C, Amabile N. Delayed Stenting for ST-Elevation Acute Myocardial Infarction in Daily Practice: A Single-Centre Experience. Can J Cardiol. 2016 Aug;32(8):988-95. doi: 10.1016/j.cjca.2015.09.015. Epub 2015 Sep 26. — View Citation

Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30. — View Citation

Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA. 2005 Mar 2;293(9):1063-72. doi: 10.1001/jama.293.9.1063. — View Citation

Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients who develop severe thrombocytopenia	platelets lower than 50000 per microliter of blood	Within hospital admission
Primary	Number of patients who develops major adverse cardiovascular events 3 months post PPCI .	Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death & CVS accidents.	3 months post PPCI
Primary	Number of patients who develops major adverse cardiovascular events 6 months post PPCI .	Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death & CVS accidents.	6 months post PPCI
Secondary	Number of patients who develop major bleeding	major bleeding defined by bleeding in critical area , fatal bleeding , loos in hemoglobin more than 5 gm/dl .	Within hospital admission
Secondary	number of patients who develop contrast induced nephropathy	impaired renal function tests including creatinine and urea after contrast use .	Within hospital admission
Secondary	Number of patients who develop allergy to tirofiban	developing rash , angioedema , dyspnea as a reaction to tirofiban	Within hospital admission