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OpenTrials
Completed

NCT Number: NCT02854423

Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous coronary interventions

Device

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

Primary outcomes

  1. major cardiac adverse events

    Time frame: 4 years

    a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR)

Secondary outcomes

  1. rate of definite stent thrombosis in revascularized patients according with ARC definition

    Time frame: 4 years

  2. Rate of composite of all-cause death in all participants

    Time frame: 4 years

  3. Rate of myocardial infarction according with definition of MI type 1in all participants

    Time frame: 4 years

  4. Rate of target-vessel revascularization (TVR) in all participants

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: RUDI 2D

Important dates

Study start
2007
Primary completion
2012
Study completion
2016
First posted
Aug 3, 2016
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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