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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bare metal stent | Active Comparator |
| |
| Endeavor sprint stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bare metal stent implantation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 12 months | |
| myocardial infarction | 12 months | |
| TVR |
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Inclusion Criteria:
A) low restenosis risk based on angiographic findings defined as follows:
----patients will be considered at low restenosis risk if no planned stent lower than 3.0 mm is intended to be implanted in lesions expect left main or vein graft
B) high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:
C) Patients at high thrombosis risk based on the presence of at least one of the following criteria:
Allergy/intolerance to aspirin
Allergy/intolerance to clopidogrel AND ticlopidine
Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).
patient with cancers (other than skin) and life expectancy >1 year
Patients with systemic conditions associated with thrombosis diathesis (e.g., hematologic disorders and any known systemic conditions determining a pro-thrombotic state including immunological disorders)
-
Exclusion Criteria:
Any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Szent-Györgyi Clinical Center, University of Szeged | Szeged | Hungary | ||||
| Ospedale San Donato |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26965932 | Derived | Ariotti S, Adamo M, Costa F, Patialiakas A, Briguori C, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Ferlini M, Vranckx P, Valgimigli M; ZEUS Investigators. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial. JACC Cardiovasc Interv. 2016 Mar 14;9(5):426-36. doi: 10.1016/j.jcin.2015.11.015. | |
| 25720624 |
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|
| zotarolimus eluting stent | Device | 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. |
|
target vessel revascularisation
| 12 months |
| stent thrombosis | 12 months |
| Arezzo |
| AR |
| 52100 |
| Italy |
| Ospedali Riuniti di Bergamo | Bergamo | BG | 24128 | Italy |
| Policlinico San Marco | Zingonia | BG | 24040 | Italy |
| Ospedale di Savigliano | Savigliano | CN | 12038 | Italy |
| Istituto Clinico Sant'Ambrogio | Milan | MI | 20149 | Italy |
| Azienda Unita' Sanitaria Locale Di Modena - Ospedale Baggiovara | Modena | MO | 41100 | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Parma | PR | 43126 | Italy |
| Policlinico San Matteo | Pavia | PV | 27100 | Italy |
| Ospedale di Ravenna | Ravenna | RA | 48121 | Italy |
| Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I | Torino | TO | 10128 | Italy |
| Ospedale San Giovanni Bosco | Torino | TO | 10154 | Italy |
| University Hospital of Ferrara | Ferrara | 44100 | Italy |
| Clinica Mediterranea | Naples | 80122 | Italy |
| Hospital de Santa Cruz | Carnaxide | Portugal |
| University Hospital of Geneva | Geneva | Switzerland |
| Derived |
| Valgimigli M, Patialiakas A, Thury A, McFadden E, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C; ZEUS Investigators. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol. 2015 Mar 3;65(8):805-815. doi: 10.1016/j.jacc.2014.11.053. |
| 24176438 | Derived | Valgimigli M, Patialiakas A, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C. Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study. Am Heart J. 2013 Nov;166(5):831-8. doi: 10.1016/j.ahj.2013.07.033. Epub 2013 Sep 26. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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