OCT or Angiography Guided De-escalation of DAPT

Official title

Evaluation of Neointimal Coverage After Guiding De-escalation of Antiplatelet Treatment in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention by Optical Coherence Tomography or Angiography of STEMI Patients

Overview

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.

Interventions

• Procedure OCT-guided PCI
  OCT-guided PCI based on MLD MAX algorithm
• Procedure Conventional angiography-based PCI
  Conventional angiography-based PCI
• Drug DAPT de-escalation
  Aspirin and clopidogrel 30 days after DES implantation
• Drug default DAPT regimen
  Aspirin and ticagrelor 30 days after DES implantation

Primary outcome measures

• Neointimal thickness after DES implantation [Time frame: At 12-month follow up after PCI]

Secondary outcome measures (3)

• Major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: During 12-month follow up]
• BARC types 2-5 bleeding [Time frame: During 12-month follow up]
• In-stent thrombosis [Time frame: During 12-month follow up]

Eligibility criteria

Inclusion criteria

• 18 \~ 85 years old adult patients;
• Patients diagnosed with STEMI and undergoing PCI.
• Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion criteria

• Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
• Allergy to aspirin or clopidogrel or ticagrelor;
• Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
• Platelet count < 50 × 109/L;
• Major bleeding during the past 12 months;
• Any form of oral, long-term anticoagulation therapy;
• Pregnancy or lactation;
• Suspected aortic dissection;
• Coronary CT-negative patients;
• Life expectancy <1 year;
• Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
• Comorbid conditions included the presence of any of the following: cardiogenic shock, chronic congestive heart failure with NYHA classes III or IV, left ventricular ejection fraction (LVEF) < 35% at transthoracic echocardiography, hypotension with SBP < 90mmHg and/or DBP < 60mmHg, severe arrhythmia (including high-degree AV block, sick sinus syndrome, sustained ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, hepatic insufficiency due to non-cardiac causes (ALT or AST more than three times the upper limit of the institution's normal reference ranges), cirrhosis, severe renal failure (eGFR < 30ml/min/1.73m2);
• Surgery plan within 30 days;
• Psychiatric abnormalities or alcohol dependence;
• Patients who are participating in other clinical trials;
• Unable to tolerate 1 month of DAPT;
• Angiographic triple vessel disease coronary disease;
• Other situations judged by the investigators not to be suitable for the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Northern Hospital — Shenyang

Publications

• 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. PMID 36922062
• 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. PMID 24239661
• 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. PMID 21742103
• 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. PMID 30522654
• 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. PMID 28510646
• 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 percutaneo PMID 28855078
• 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. PMID 24291273
• 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-i PMID 34627490

Identifiers

NCT: NCT06339021 · DAPT-OCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗