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Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.
Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT-guided PCI and DAPT De-escalation | Experimental | OCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients |
|
| OCT-guided PCI and default DAPT regimen | Experimental | OCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients |
|
| Conventional angiography-based PCI and DAPT De-escalation | Experimental | Conventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients |
|
| Conventional angiography-based PCI and default DAPT regimen | Active Comparator | Conventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT-guided PCI | Procedure | OCT-guided PCI based on MLD MAX algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal thickness after DES implantation | Stent and luminal cross-sectional areas (CSAs) were measured. Neointimal CSA was calculated as stent CSA minus lumen CSA. Neointimal thickness was measured as the distance between endoluminal surface of neointima and strut, which was obtained at 12-month follow-up. | At 12-month follow up after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular events (MACCE) | Defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization | During 12-month follow up |
| BARC types 2-5 bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaling Han | Contact | 86-24-28856123 | cardiology@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaling Han | Shenyang Northern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Hospital | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36922062 | Background | Ali ZA, Karimi Galougahi K, Thomas SV, Abu-Much A, Chau K, Dakroub A, Shlofmitz ES, Jeremias A, West N, Matsumura M, Mintz GS, Maehara A, Shlofmitz RA. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention: Practical Application. Interv Cardiol Clin. 2023 Apr;12(2):215-224. doi: 10.1016/j.iccl.2022.12.003. Epub 2023 Jan 31. | |
| 24239661 |
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| Conventional angiography-based PCI | Procedure | Conventional angiography-based PCI |
|
| DAPT de-escalation | Drug | Aspirin and clopidogrel 30 days after DES implantation |
|
| default DAPT regimen | Drug | Aspirin and ticagrelor 30 days after DES implantation |
|
Defined as all BARC type 2-5 bleeding events
| During 12-month follow up |
| In-stent thrombosis | In-stent thrombosis was defined as new ST elevation with anginal symptoms or an equivalent due to thrombotic occlusion of the stent placed at the culprit lesion confirmed by coronary angiography during the index hospitalization. | During 12-month follow up |
| Giugliano RP, Braunwald E. The year in acute coronary syndrome. J Am Coll Cardiol. 2014 Jan 28;63(3):201-14. doi: 10.1016/j.jacc.2013.10.041. Epub 2013 Nov 13. No abstract available. |
| 21742103 | Background | Bliden KP, Tantry US, Storey RF, Jeong YH, Gesheff M, Wei C, Gurbel PA. The effect of ticagrelor versus clopidogrel on high on-treatment platelet reactivity: combined analysis of the ONSET/OFFSET and RESPOND studies. Am Heart J. 2011 Jul;162(1):160-5. doi: 10.1016/j.ahj.2010.11.025. Epub 2011 Jun 12. |
| 30522654 | Background | Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2915-2931. doi: 10.1016/j.jacc.2018.09.057. |
| 28510646 | Background | Cuisset T, Deharo P, Quilici J, Johnson TW, Deffarges S, Bassez C, Bonnet G, Fourcade L, Mouret JP, Lambert M, Verdier V, Morange PE, Alessi MC, Bonnet JL. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J. 2017 Nov 1;38(41):3070-3078. doi: 10.1093/eurheartj/ehx175. |
| 28855078 | Background | Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28. |
| 24291273 | Background | Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27. |
| 34627490 | Background | Kim CJ, Park MW, Kim MC, Choo EH, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Shin ES, Jeong YH, Seung KB, Jeong MH, Yim HW, Ahn Y, Chang K; TALOS-AMI investigators. Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial. Lancet. 2021 Oct 9;398(10308):1305-1316. doi: 10.1016/S0140-6736(21)01445-8. |
| 37622654 | Background | Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available. |
| 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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