Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial: rationale, objectives and design.
BACKGROUND
Novel approaches to modify stents have been developed to address the limitations of bare-metal stents (BMS) and drug-eluting stent (DES), aiming for ideal features, such as decreased restenosis rates with decreased thrombogenicity and without the need for long-term dual antiplatelet therapy.


BACKGROUND
The Assessment of The LAtest Non-Thrombogenic Angioplasty Stent (ATLANTA) trial was the first-in-man study to show the safety and efficacy of the Polyzene-F coated CATANIA stent (CeloNova BioSciences, Newnan, Georgia, USA) as an alternative to both BMS and DES. The stent was found to be associated with a good clinical outcome with no vessel thrombosis and a modest growth of late neointima. A subgroup undergoing optical coherence tomography late assessment showed almost complete stent strut coverage at 6 months. However, whether the CATANIA stent is superior in promoting a greater stent strut coverage rate both at 7 and 30 days with respect to DES and BMS is unknown.


METHODS
The Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial will be a prospective, randomized study providing new evidence on early vessel healing and thrombus development after stenting with different stent types. Optical coherence tomography examination at 7-10 days or 28-32 days after implantation will evaluate strut coverage and vessel healing. The primary endpoint will be a comparison of the percentage of 'healed stent struts' at 28-32 days, identified by the presence of an evenly apposed rim of tissue on stent struts, and without apposition of thrombotic material, on the total amount of analyzed struts for the stent groups.
Tamburino
Corrado
C
Cardiology Department, Ferrarotto Hospital, University of Catania, Italy. tambucor@unict.it
Capodanno
Davide
D
La Manna
Alessio
A
di Salvo
Marilena
M
Sanfilippo
Alessandra
A
Prati
Francesco
F
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000473:pathology*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014945:Wound Healing
D020099:Coated Materials, Biocompatible; D008670:Metals; D010975:Platelet Aggregation Inhibitors