OCT guided vs. COmplete pci in patieNts with sT segment elevation myocArdial infarCtion and mulTivessel disease:
Mario Iannaccone1, Ovidio DE Filippo2, Andrea Montabone2
1Division of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy - mario.iannaccone@hotmail.it.
Insights
This study investigates if optical coherence tomography (OCT)-guided treatment of non-culprit lesions in ST-elevation myocardial infarction (STEMI) patients is as effective as standard care. OCT guidance may offer a more targeted approach for managing complex coronary artery disease.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Imaging
Background:
- ST-segment elevation myocardial infarction (STEMI) management often involves percutaneous coronary intervention (PCI) for the culprit lesion.
- Optimal treatment for non-culprit lesions in multivessel disease post-STEMI remains debated.
- The role of optical coherence tomography (OCT) in identifying plaque instability for guiding non-culprit lesion treatment is unclear.
Purpose of the Study:
- To compare the efficacy of an OCT-guided approach versus a standard angiographic/functional approach for non-culprit lesions in STEMI patients.
- To determine if OCT-guided PCI of non-culprit lesions is non-inferior to complete PCI in reducing major adverse cardiovascular events.
- To evaluate the safety and efficacy of a novel OCT-guided strategy in managing multivessel coronary artery disease following primary PCI.
Main Methods:
- Prospective, multicenter, randomized controlled trial (OCT-Contact) comparing OCT-guided PCI (Group A) with complete PCI (Group B) for non-culprit lesions.
- Patients with STEMI and multivessel disease underwent randomization after successful primary PCI.
- Treatment in Group A focused on plaque vulnerability identified by OCT; Group B utilized fractional flow reserve at operator discretion.
Main Results:
- The study requires a sample size of 406 patients (203 per group) for 80% power to detect non-inferiority.
- The primary efficacy outcome is a composite of major adverse cardiovascular events (MACE) including mortality, MI, revascularization, and heart failure.
- Secondary endpoints include individual MACE components, cardiovascular mortality, and safety outcomes like renal failure, procedural complications, and bleeding, with a 24-month follow-up.
Conclusions:
- An OCT-guided morphological approach has the potential to be a more specific treatment strategy for non-culprit lesions in STEMI patients.
- This approach may refine treatment decisions beyond standard angiography and functional assessments.
- Further research is needed to confirm the non-inferiority and clinical benefits of OCT-guided PCI in this patient population.
Background:
In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significantly reduces the risk of cardiovascular death. However, the management of non-culprit lesions in patients with the multivessel disease remains a matter of debate in this setting. It's still unclear if a morphological OCT-guided approach, identifying coronary plaque instability, may provide a more specific treatment compared with a standard angiographic/functional approach.
Methods:
OCT-Contact is a prospective, multicenter, open-label, non-inferiority randomized controlled trial. Patients with STEMI with successful primary PCI of the culprit lesion will be enrolled after the index PCI. Patients will be deemed eligible if a critical coronary lesion other than the culprit (associated with a diameter of stenosis ≥50%) will be identified during the index angiography. Patients will be randomized in a 1:1 fashion to OCT-guided PCI of non-culprit lesions (Group A) vs. complete PCI (Group B). PCI in group A will be undertaken according to criteria of plaque vulnerability, while in group B the use of fractional flow reserve will be left at the operators' discretion. Major-adverse cardiovascular events (MACE) are a composite of all-cause mortality, non-fatal myocardial infarction (MI) (excluding peri-procedural MI), unplanned revascularization, and NYHA IV heart failure) will be the primary efficacy outcome. Single components of MACE along with cardiovascular mortality will be the secondary endpoints. . Safety endpoints will embrace worsening of renal failure, procedural complications, and bleedings. Patients will be followed for 24 months after randomization.
Results:
A sample size of 406 patients (203 per group) is required to provide the analysis an 80% power to detect a non-inferiority in the primary endpoint with an alpha error set at 0.05 and a non-inferiority limit of 4%.
Conclusions:
A morphological OCT-guided approach may be a more specific treatment compared with the standard angiographic/functional approach in non-culprit lesions of STEMI patients.
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