Rationale and study design of the RESERVOIR trial: a randomized trial comparing reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents with durable polymer in patients with diabetes mellitus.
BACKGROUND
Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES).


METHODS
This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013.


CONCLUSIONS
The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748).
Department of Cardiology, Heart Diseases Institute, Hospital de Bellvitge, IDIBELL, University of Barcelona, Barcelona, Spain.
R
R
Romaguera
S
S
Brugaletta
J
J
Gomez-Lara
E
E
Pinar
P
P
Jiménez-Quevedo
M
M
Gracida
G
G
Roura
J L
JL
Ferreiro
L
L
Teruel
J A
JA
Gómez-Hospital
E
E
Montanya
F
F
Alfonso
M
M
Valgimigli
M
M
Sabate
A
A
Cequier
D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D002985:Clinical Protocols; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005227:Fatty Acids / Q000008:administration & dosage*; D006801:Humans; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D011474:Prosthesis Design; D012107:Research Design; D013030:Spain; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D002858:Chromium Alloys; D005227:Fatty Acids; D011108:Polymers; D000068338:Everolimus
diabetes mellitus; drug-eluting stent; percutaneous coronary intervention