TY - JOUR
T1 - Italian diffuse/multivessel disease Absorb prospective registry (IT-DISAPPEARS). Study design and rationale
AU - Testa, Luca
AU - Zoccai, Giuseppe Biondi
AU - Tomai, Fabrizio
AU - Ribichini, Flavio
AU - Indolfi, Ciro
AU - Tamburino, Corrado
AU - Bartorelli, Antonio
AU - Petronio, Anna Sonia
AU - Bedogni, Francesco
AU - De Carlo, Marco
PY - 2015/3/1
Y1 - 2015/3/1
N2 - Background: The Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) is an everolimus-eluting bioresorbable vascular scaffold able to provide temporary scaffolding and antiproliferative drug delivery for the treatment of coronary artery disease. This temporary scaffolding could be the true feature to overcome the limitations of the conventional metallic stents. A growing body of evidence worldwide is supporting its implementation into daily practice as being associated with comparable results as the second-generation everolimuseluting stent. However, these pieces of evidence come from 'studies in which the majority of the patients had low-risk stenoses', whereas patients with more complex coronary artery disease could benefit the most from the Absorb BVS technology. Methods: The aim of the IT-DISAPPEARS is to investigate the procedural and clinical performance of the Absorb BVS in patients with long (≥24 mm), single-vessel coronary disease or with multivessel disease. At least 50 centers across the Italian territory will enroll 1000 patients with either stable or acute coronary syndromes. Follow-up will end up at 5 years. Primary endpoint will be the cumulative hierarchical incidence of major adverse cardiac events at 1 year, defined as: cardiac death, nonfatal target vessel myocardial infarction, or clinically driven target lesion revascularization. The efficacy as well as safety parameters will be evaluated along with a detailed evaluation of the dual antiplatelet therapy duration/interruption. Conclusion: The IT-DISAPPEARS could provide the first evidence worldwide concerning the performance of Absorb BVS in patients with high-risk diffuse coronary disease.
AB - Background: The Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) is an everolimus-eluting bioresorbable vascular scaffold able to provide temporary scaffolding and antiproliferative drug delivery for the treatment of coronary artery disease. This temporary scaffolding could be the true feature to overcome the limitations of the conventional metallic stents. A growing body of evidence worldwide is supporting its implementation into daily practice as being associated with comparable results as the second-generation everolimuseluting stent. However, these pieces of evidence come from 'studies in which the majority of the patients had low-risk stenoses', whereas patients with more complex coronary artery disease could benefit the most from the Absorb BVS technology. Methods: The aim of the IT-DISAPPEARS is to investigate the procedural and clinical performance of the Absorb BVS in patients with long (≥24 mm), single-vessel coronary disease or with multivessel disease. At least 50 centers across the Italian territory will enroll 1000 patients with either stable or acute coronary syndromes. Follow-up will end up at 5 years. Primary endpoint will be the cumulative hierarchical incidence of major adverse cardiac events at 1 year, defined as: cardiac death, nonfatal target vessel myocardial infarction, or clinically driven target lesion revascularization. The efficacy as well as safety parameters will be evaluated along with a detailed evaluation of the dual antiplatelet therapy duration/interruption. Conclusion: The IT-DISAPPEARS could provide the first evidence worldwide concerning the performance of Absorb BVS in patients with high-risk diffuse coronary disease.
UR - http://www.scopus.com/inward/record.url?scp=84925851874&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84925851874&partnerID=8YFLogxK
U2 - 10.2459/JCM.0000000000000219
DO - 10.2459/JCM.0000000000000219
M3 - Article
C2 - 25469734
AN - SCOPUS:84925851874
VL - 16
SP - 253
EP - 258
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
SN - 1558-2027
IS - 3
ER -