Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus

Phase 4

Withdrawn

• Conditions: Diabetes Mellitus; Coronary Artery Disease
• Interventions: Device: Xience Prime stent; Device: Integrity Resolute stent; Device: Taxus Element stent

• Registration Number: NCT01293773
• Lead Sponsor: Policlinico Casilino ASL RMB

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Status Verified: 2011-08
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subject is > 18 years old
2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent
3. Subject and the treating physician agree that the subject will comply with all follow-up evaluations
4. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria

1. Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure
2. The patient is pregnant or breastfeeding
3. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated)
4. A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3
5. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
6. Prior participation in this study
7. Active peptic ulcer or upper GI bleeding within the prior 3 months
8. Subject has active sepsis
9. Any lesion that is located in a saphenous vein graft
10. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xience Prime	Xience Prime stent	Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
Integrity Resolute	Integrity Resolute stent	Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
Taxus Element	Taxus Element stent	Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)

Primary Outcome Measures

Name	Time	Method
Target lesion failure	1 year	Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization	1, 2 and 3 year	Target lesion revascularization at 12, 24 and 36 months
Effect of glucose levels on repeat revascularization	1 year	Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
Effect of dual antiplatelet therapy on outcome	3 year	Comparison of 12-month versus prolonged (\> 12-month) dual antiplatelet therapy on outcome

Trial Locations

Locations (2)

Azienda Policlinico-Universitaria di Modena; 🇮🇹 Modena, Italy

Policlinico Casilino; 🇮🇹 Rome, Italy