Cardiovascular revascularization medicine : including molecular interventions · 2015
Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Moscarella Elisabetta, Varricchio Attilio, Stabile Eugenio, Franzone Anna, Granata Francesco, Rapacciuolo Antonio, Galasso Gennaro, Capozzolo Claudia, Cirillo Plinio, Monda Vittorio, Monterforte Ida, Borgia Francesco, Piro Orlando, Bonzani Giulio, Trimarco Bruno, Esposito Giovanni
Аннотация
BACKGROUND/PURPOSE: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR.
METHODS/MATERIALS: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months.
RESULTS: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6±15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%).
CONCLUSIONS: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.
METHODS/MATERIALS: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months.
RESULTS: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6±15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%).
CONCLUSIONS: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.
Предметные рубрики MeSH
Absorbable ImplantsAgedCardiovascular AgentsCoated Materials, BiocompatibleCoronary AngiographyCoronary RestenosisCoronary ThrombosisFeasibility StudiesFemaleHumansItalyMaleMiddle AgedPercutaneous Coronary InterventionProspective StudiesProsthesis DesignRegistriesRetreatmentStentsTime FactorsTomography, Optical CoherenceTreatment Outcome