Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent

Prospective Optical cohereNce Tomography Evaluation of neoINtimal Coverage of a biodegrAdable Polymer-based Drug-eluting Stent

PONTINA aims at assessing by optical coherence tomography the neointimal coverage of the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) after full drug elution and polymer biodegradation (6 months), at one month after this time-point (7 months) and, as a comparator, of its bare metal stent counterpart (Gazelle stent) at 1 month after implantation.

Inclusion Criteria:

• age >50 years
• de novo lesion
• lesion length <24 mm
• reference vessel diameter 3 mm

Exclusion Criteria:

• low compliance to dual antiplatelet therapy
• life expectancy <1 year
• allergy to any drug or substance use prior, during or after percutaneous coronary intervention
• chronic renal insufficiency
• low left ventricle ejection fraction (<35%)
• recent acute myocardial infarction
• previous coronary intervention
• off-label indication to stenting
• participation in another investigation
• refusal to participate to the study