Josep Gomez-Lara1, Salvatore Brugaletta2, Francisco Jacobi2, Luis Ortega-Paz2, Marcos Ñato2, Gerard Roura2, Rafael Romaguera2, Jose-Luis Ferreiro2, Luis Teruel2, Montserrat Gracida2, Victoria Martin-Yuste2, Xavier Freixa2, Monica Masotti2, Joan-Antoni Gomez-Hospital2, Manel Sabate2, Angel Cequier2. 1. From the Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain (J.G.-L., F.J., M.Ñ., G.R., R.R., J.-L.F., L.T., M.G., J.-A.G.-H., A.C.); and Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Spain (S.B., L.O.-P., V.M.-Y., X.F., M.M., M.S.). gomezjosep@hotmail.com. 2. From the Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain (J.G.-L., F.J., M.Ñ., G.R., R.R., J.-L.F., L.T., M.G., J.-A.G.-H., A.C.); and Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Spain (S.B., L.O.-P., V.M.-Y., X.F., M.M., M.S.).
Abstract
BACKGROUND: The main causes of late (>1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment-elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment-elevation myocardial infarction at 5 years. METHODS AND RESULTS: One hundred and sixty-nine consecutive event-free patients of the randomized EXAMINATION study (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) were screened for optical coherence tomographic imaging at 5 years. Patients with target vessel-related events or life-threatening comorbidities were excluded. Finally, 64 patients (32 EES and 32 BMS) underwent optical coherence tomographic imaging. At 5 years, uncovered struts (4.1% versus 1.0%; P<0.01), length of uncoverage (3.4 versus 1.4 mm; P=0.02), and ratio of uncovered to total struts per cross-section ≥30% (35.5% versus 9.7%; P=0.02) were larger with EES than that with BMS. Malapposed struts (1.2% versus 0.3%; P=0.02) and malapposition length (1.3 versus 0.4 mm; P=0.06) were also larger with EES. Neoatherosclerotic plaques (16.1% versus 25.8%; P=0.35) and macrophage accumulations (19.4% versus 48.4%; P=0.02) were numerically more frequent with BMS. CONCLUSIONS: Despite substantial dropout of patients, the healing pattern in event-free ST-segment-elevation myocardial infarction patients differs between EES and BMS at 5 years. EES presented with larger amount of uncovered and malapposed struts and similar rate of neoatherosclerosis as compared with BMS. The clinical relevance of these findings warrants longer follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00828087.
RCT Entities:
BACKGROUND: The main causes of late (>1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment-elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment-elevation myocardial infarction at 5 years. METHODS AND RESULTS: One hundred and sixty-nine consecutive event-free patients of the randomized EXAMINATION study (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) were screened for optical coherence tomographic imaging at 5 years. Patients with target vessel-related events or life-threatening comorbidities were excluded. Finally, 64 patients (32 EES and 32 BMS) underwent optical coherence tomographic imaging. At 5 years, uncovered struts (4.1% versus 1.0%; P<0.01), length of uncoverage (3.4 versus 1.4 mm; P=0.02), and ratio of uncovered to total struts per cross-section ≥30% (35.5% versus 9.7%; P=0.02) were larger with EES than that with BMS. Malapposed struts (1.2% versus 0.3%; P=0.02) and malapposition length (1.3 versus 0.4 mm; P=0.06) were also larger with EES. Neoatherosclerotic plaques (16.1% versus 25.8%; P=0.35) and macrophage accumulations (19.4% versus 48.4%; P=0.02) were numerically more frequent with BMS. CONCLUSIONS: Despite substantial dropout of patients, the healing pattern in event-free ST-segment-elevation myocardial infarctionpatients differs between EES and BMS at 5 years. EES presented with larger amount of uncovered and malapposed struts and similar rate of neoatherosclerosis as compared with BMS. The clinical relevance of these findings warrants longer follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00828087.