Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients

Completed

• Conditions: Percutaneous Coronary Intervention; Diabetes Mellitus
• Interventions: Device: percutaneous coronary interventions

• Registration Number: NCT02854423
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2012-05
• Study Completion: 2016-01
• Study First Submitted: 2016-02-01
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1347

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biodegradable polymer	percutaneous coronary interventions	-
durable-polymer	percutaneous coronary interventions	-

Primary Outcome Measures

Name	Time	Method
major cardiac adverse events	4 years	a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR)

Secondary Outcome Measures

Name	Time	Method
Rate of target-vessel revascularization (TVR) in all participants	4 years
Rate of myocardial infarction according with definition of MI type 1in all participants	4 years
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