Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study

Marco Valgimigli

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: zotarolimus eluting stent; Device: Bare metal stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01385319

ZEUS-10-II

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,606 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

1. Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
2. Recent (within previous 12 months) bleeding episode(s) which required medical attention
3. Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)
4. Age greater than 80
5. Systemic conditions associated to increased bleeding risk (e.g. hematological disorders or any known coagulopathy determining bleeding diathesis, including history of or current thrombocytopenia defined as platelet count <100,000/mm3 (<100 x 109/L).
6. Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss
7. Need for chronic treatment with steroids or NSAID

C) Patients at high thrombosis risk based on the presence of at least one of the following criteria:

1. Allergy/intolerance to aspirin

2. Allergy/intolerance to clopidogrel AND ticlopidine

3. Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).

4. patient with cancers (other than skin) and life expectancy >1 year

5. 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:

     1. Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
     2. Subjects who are unable to give informed consent and assurance for complete contact through 12 months.
     3. PCI with stenting in the previous 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,606 participants in 2 patient groups

bare metal stent

Active Comparator group

Treatment:

Device: Bare metal stent implantation

Endeavor sprint stent

Experimental group

Treatment:

Device: zotarolimus eluting stent