Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients

Diabetes Mellitus Clinical Trial

— RUDI 2D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854423
• Other study ID #: RUDI 2D
• Status: Completed
• Phase: N/A
• First received: February 1, 2016
• Last updated: July 29, 2016
• Start date: January 2007
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1347
• Est. completion date: January 2016
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major cardiac adverse events	a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR)	4 years	Yes
Secondary	rate of definite stent thrombosis in revascularized patients according with ARC definition		4 years	Yes
Secondary	Rate of composite of all-cause death in all participants		4 years	Yes
Secondary	Rate of myocardial infarction according with definition of MI type 1in all participants		4 years	Yes
Secondary	Rate of target-vessel revascularization (TVR) in all participants		4 years	Yes