OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT04878133
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT

Detailed Description

In patients with ST segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significally reduces the risk of cardiovascular death. How to manage in this setting non-culprit lesion in patients with multivessel disease still remain a matter of debate. Recently, the COMPLETE trial showed that complete PCI of every coronary stenosis \> 70% (or 50-69% lesions with FFR \< 0.8) reduces risk of myocardial infarction (MI) and unstable angina (UA) at 3 years compared with culprit-lesion PCI \[1\]. Whether this findings are related to revascularization of every obstructive lesions rather than lesions with vulnerable-plaque characteristics, still remain unclear.

In high risk patients such as STEMI patients, physiopathology of coronary plaque deeply differs from stable angina, mainly due to peculiar features of plaque. STEMI lesions, when evaluated at autopsy or at intracoronary imaging, showed a pro-thrombotic pattern, with high prevalence of thin cap fibro-atheroma, plaque rupture or thrombus, and a larger amount of lipids and macrophage \[2-6\]. In this setting, angiography, even when combined with fractional flow reserve evaluation (which can describe more accurately the functional impact of the plaque), has intrinsic limitations because of lack of information about plaque characteristics \[7,8\].

Optical coherence tomography (OCT) is the latest development in intravascular coronary imaging. Similarly to intravascular ultrasound (IVUS), OCT provides cross-sectional images of the vessel. However, instead of sound, OCT employs light for tissue analysis that enables visualization of the coronary lesions with almost microscopic precision \[9,10\].

This tool can find high risk vulnerable plaque without angiographic or functional signs of severity, helping from misdiagnosing and under-treating these lesions, that could benefit from PCI even more than obstructive lesions without vulnerable plaque characteristics.

In an OCT substudy of the COMPLETE trial, researchers determined that half of patients had obstructive nonculprit lesions with vulnerable plaque, which could explain why complete revascularization conferred better outcomes than culprit lesion-only revascularization in the main trial. This substudy pointed out also a 20% of non-obstructive non-culprit lesions with vulnerable plaque caracteristics and up to 30% of obstructive non-culprit lesions without high risk morphology \[11\]. It suggest that a morphological approach to PCI in high risk patients can provide a more specific treatment compared with standard angiographic/functional approach. A correct identification of coronary plaque instability in a setting of STEMI patients could deeply impact in these patients risk of cardiovascular events, angina and re- hospitalization.

Being coronary artery disease a pandemic disease with an important impact on nations health care, a reduction in events in these patients do not impact only on patients quality of life, but on health care system resources.

Consequently, we propose a randomized controlled trial to evaluate the effective benefit of OCT guided vs complete PCI in STEMI patients with multivessels coronary artery disease.

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-07
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11
• Primary Completion: 2023-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Patients with STEMI and residual non culprit CAD
2. Informed consent

Exclusion Criteria

1. Refusal or inability to provide informed consent.
2. < 18 years of age
3. Cardiogenic shock
4. Previous Coronary Artery Bypass Grafting (CABG
5. Indication for revascularization by CABG.
6. eGFR < 30 ml/min/m2
7. ULM stenosis
8. Estimated life expectancy < 3 year
9. Non culprit CTO lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE)	24 mounth after the recruitment in the study	Composite endopoint of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization.

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy end-points	24 mounth after the recruitment in the study	Rate of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization taking separately.

Trial Locations

Locations (6)

Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Piemonte, Italy

Ospedale San Luigi Gonzaga, Orbassano; 🇮🇹 Orbassano, Italy

Ospedale di Rivoli; 🇮🇹 Rivoli, Italy

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy

Ospedale San Giovanni Bosco; 🇮🇹 Torino, Italy

Citta della Salute; 🇮🇹 Turin, Italy