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

University of Roma La Sapienza

Status: Completed

Conditions: Percutaneous Coronary Intervention; Diabetes Mellitus

Treatments: Device: percutaneous coronary interventions

Study type: Observational

Funder types: Other

Identifiers

NCT02854423

RUDI 2D

Details and patient eligibility

About

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).

Enrollment: 1,347 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,347 participants in 2 patient groups

biodegradable polymer

Treatment:

Device: percutaneous coronary interventions

durable-polymer

Treatment:

Device: percutaneous coronary interventions