Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design.
BACKGROUND
The Absorb everolimus-eluting bioresorbable vascular scaffold (AbsorbBVS) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents, providing temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease.


METHODS
The objective of the AIDA trial is to evaluate the efficacy and performance in an contemporary all-comer population of the AbsorbBVS strategy vs the XIENCE family everolimus-eluting metallic coronary stent system in the treatment of coronary lesions. The AIDA trial is a prospective, randomized (1:1), active-control, single-blinded, all-comer, noninferiority trial. A total of 2,690 subjects will be enrolled with broad inclusion and limited exclusion criteria according to the "Instructions for Use" of the AbsorbBVS strategy. The study population includes both simple and complex lesions, in patients with stable and acute coronary syndrome. The follow-up continues for 5years. The primary end point of the trial is target vessel failure, defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization, at 2years. This study is registered on ClinicalTrials.gov with number NCT01858077.


CONCLUSIONS
The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice.
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Pier
P
Woudstra
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Maik J
MJ
Grundeken
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Robin P
RP
Kraak
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Mariëlla E C J
ME
Hassell
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
E Karin
EK
Arkenbout
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Jan
J
Baan
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Marije M
MM
Vis
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Karel T
KT
Koch
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Jan G P
JG
Tijssen
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Jan J
JJ
Piek
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
Robbert J
RJ
de Winter
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands.
José P S
JP
Henriques
Heartcenter, Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands. Electronic address: j.j.wykzykowska@amc.uva.nl.
Joanna J
JJ
Wykrzykowska
D000368:Aged; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D000068338:Everolimus; D020123:Sirolimus