TY - JOUR
T1 - OCT guided vs. COmplete pci in patieNts with sT segment elevation myocArdial infarCtion and mulTivessel disease
T2 - OCT-CONTACT RCT
AU - Iannaccone, Mario
AU - De Filippo, Ovidio
AU - Montabone, Andrea
AU - Marengo, Giorgio
AU - Maltese, Ludovica
AU - Ugo, Fabrizio
AU - Quadri, Giorgio
AU - Mennuni, Maro
AU - Secco, Gioel G.
AU - Taglialatela, Vittorio
AU - Cinconze, Sebastian
AU - Moretti, Claudio
AU - Truffa, Alessandra
AU - Gambino, Alfonso
AU - Boccuzzi, Giacomo
AU - Infantino, Vincenzo
AU - Conrotto, Federico
AU - Lupi, Alessandro
AU - Varbella, Ferdinando
AU - Patti, Giuseppe
AU - Rognoni, Andrea
AU - Musumeci, Giuseppe
AU - Prati, Francesco
AU - De ferrari, Gaetano M.
AU - D'ascenzo, Fabrizio
N1 - Publisher Copyright:
© 2022 ediZioNi MiNerVa MediCa.
PY - 2023/8
Y1 - 2023/8
N2 - 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.
AB - 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.
KW - Percutaneous coronary intervention
KW - ST elevation myocardial infarction
KW - Tomography
KW - optical coherence
UR - https://www.scopus.com/pages/publications/85164624349
U2 - 10.23736/S2724-5683.22.06144-0
DO - 10.23736/S2724-5683.22.06144-0
M3 - Article
SN - 2724-5683
VL - 74
SP - 431
EP - 437
JO - Minerva Cardiology and Angiology
JF - Minerva Cardiology and Angiology
IS - 4
ER -