To prospectively evaluate in a multicenter open label trial whether the use of zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac events (MACE) including overall death, any myocardial infarction (MI) or any target vessel revascularization (TVR).
The aim of this study is to conduct a multicenter, international, randomized trial to test whether the Endeavor stent is superior to BMS in terms of efficacy and safety in 1. Patients with coronary artery disease lesions at low risk of in-stent restenosis; 2. Patients at high risk for bleeding or carrying impossibility to comply with dual anti-platelet treatment at long-term. 3. Patients at high thrombosis risk due to systemic disorders or planned non-cardiac surgery within 12 months As the use of DES in these two patient/lesion subsets is debated due to lack of evidence, patients fulfilling at least one of these three medical conditions qualify for bare metal stent implantation and physicians may believe DES to be even contra-indicated in such cases. The current protocol has been developed on purpose to address the value of the Endeavor Sprint stent, which differs in many aspects from other FDA approved DES, including fast and complete degree of strut coverage after implantation and quick release of active drug after deployment (\~15 days) which may help decreasing the need for prolonged dual antiplatelet treatment down to 1 month as it is currently recommended for bare metal stent implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,606
After BMS implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient as follows: Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients. Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days. Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month.
After ZES implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient (i.e. identical to criteria set out for BMS patients) as follows: Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients. Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days. Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month.
Albert Szent-Györgyi Clinical Center, University of Szeged
Szeged, Hungary
Ospedale San Donato
Arezzo, AR, Italy
Ospedali Riuniti di Bergamo
Bergamo, BG, Italy
MACE
Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation
Time frame: 12 months
Death
Time frame: 12 months
myocardial infarction
Time frame: 12 months
TVR
target vessel revascularisation
Time frame: 12 months
stent thrombosis
Time frame: 12 months
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Policlinico San Marco
Zingonia, BG, Italy
Ospedale di Savigliano
Savigliano, CN, Italy
Istituto Clinico Sant'Ambrogio
Milan, MI, Italy
Azienda Unita' Sanitaria Locale Di Modena - Ospedale Baggiovara
Modena, MO, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy
Policlinico San Matteo
Pavia, PV, Italy
Ospedale di Ravenna
Ravenna, RA, Italy
...and 6 more locations