Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients

Study Overview
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Brief Summary
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Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. BP-BES with DP-EES have been directly compared in 2 randomized trials, showing no differences between the two devices in all-comer patients during long-term follow-up. It is unknown whether these results are consistent in real-world patients with diabetes mellitus during long-term follow-up. To evaluate the safety and efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes mellitus during long-term follow-up. Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation were included in a multicenter registry between January 2007 and May 2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR). Secondary endpoints are the individual components of the primary endpoint as well as definite stent thrombosis (ST).

Official Title
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Long-term Comparison of Biodegradable Polymer Biolimus-eluting Stents and Durable-polymer Everolimus-eluting Stents in Patients With Diabetes Mellitus

Conditions
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Percutaneous Coronary Intervention, Diabetes Mellitus

Intervention / Treatment
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* Device: percutaneous coronary interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years diabetes mellitus percutaneous coronary interventions with biolimus eluting stent or everolimus eluting stent implantation signed informed consent Exclusion Criteria: planned procedure requiring antiplatelet therapy withdrawal within 12 months from index coronary angioplasty patients with contraindication to dual antiplatelet therapy (aspirin plus ticlopidine or clopidogrel) known allergy to stent drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| biodegradable polymer<br> | Device: percutaneous coronary interventions<br>* Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation<br>|
| durable-polymer<br> | Device: percutaneous coronary interventions<br>* Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major cardiac adverse events | a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of definite stent thrombosis in revascularized patients according with ARC definition |  | 4 years | 
| Rate of composite of all-cause death in all participants |  | 4 years | 
| Rate of myocardial infarction according with definition of MI type 1in all participants |  | 4 years | 
| Rate of target-vessel revascularization (TVR) in all participants |  | 4 years |