Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12. Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months. Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (\> 12 months) of dual antiplatelet therapy
Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
paclitaxel-eluting stent
ABT 578-eluting stent
Everolimus-eluting stent
Azienda Policlinico-Universitaria di Modena
Modena, Modena, Italy
Policlinico Casilino
Rome, Rome, Italy
Target lesion failure
Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion
Time frame: 1 year
Effect of glucose levels on repeat revascularization
Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
Time frame: 1 year
Target Lesion Revascularization
Target lesion revascularization at 12, 24 and 36 months
Time frame: 1, 2 and 3 year
Effect of dual antiplatelet therapy on outcome
Comparison of 12-month versus prolonged (\> 12-month) dual antiplatelet therapy on outcome
Time frame: 3 year
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