Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2016-01-31

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).

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Detailed Description

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Conditions

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Percutaneous Coronary Intervention Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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biodegradable polymer

percutaneous coronary interventions

Intervention Type DEVICE

Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation

durable-polymer

percutaneous coronary interventions

Intervention Type DEVICE

Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation

Interventions

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percutaneous coronary interventions

Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No