Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients (RUDI 2D)

July 29, 2016 updated by: Gennaro Sardella, University of Roma La Sapienza

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive diabetic patients with coronary artery diseases undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation between January 2007 and May 2012

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
biodegradable polymer
Device: percutaneous coronary interventions
Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation
durable-polymer
Device: percutaneous coronary interventions
Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUDI 2D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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