Abstract
BaCKgroUNd: in patients with ST-segment elevation myocardial infarction (STeMi), percutaneous coronary inter-vention (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 worsen-ing 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 STEMIpatients.
| Original language | English |
|---|---|
| Pages (from-to) | 431-437 |
| Number of pages | 7 |
| Journal | Minerva Cardiology and Angiology |
| Volume | 74 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Aug 2023 |
| Externally published | Yes |
Keywords
- Percutaneous coronary intervention
- ST elevation myocardial infarction
- Tomography
- optical coherence
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