Clinical trial NCT02854423: Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients
Official title: Long-term Comparison of Biodegradable Polymer Biolimus-eluting Stents and Durable-polymer Everolimus-eluting Stents in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Diabetes Mellitus
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 1347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: major cardiac adverse events
timeFrame: 4 years
Secondary outcomes:
measure: rate of definite stent thrombosis in revascularized patients according with ARC definition
timeFrame: 4 years
measure: Rate of composite of all-cause death in all participants
timeFrame: 4 years
measure: Rate of myocardial infarction according with definition of MI type 1in all participants
timeFrame: 4 years
measure: Rate of target-vessel revascularization (TVR) in all participants
timeFrame: 4 years
Other outcomes:
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