To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.
The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,845
Bioresorbable scaffold
Drug eluting metallic stent
AMC
Amsterdam, North Holland, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
TerGooi Hospital
Hilversum, Netherlands
Medical Center Leeuwarden
Target Vessel Failure (TVF)
The primary composite endpoint is the device-oriented composite of target vessel failure (TVF): * Cardiac death * Myocardial Infarction (MI) (unless clearly attributable to a non target vessel) * Target vessel revascularization
Time frame: 2 years
Device success
Successful delivery and deployment of the first study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 20% by quantitative coronary angiography (QCA) and thrombolysis in myocardial infarction (TIMI) 3 flow grade of the treated vessel.
Time frame: 1 day
Procedural success
Achievement of final in-scaffold/stent residual stenosis of less than 20% by QCA and TIMI 3 flow grade of the treated vessel with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat Target Lesion Revascularization during the hospital stay.
Time frame: 1 day
Target vessel failure (TVF)
Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization
Time frame: 30 days, and 1, 3, 4 and 5 years
Target lesion failure
Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization
Time frame: 30 days, and 1, 2, 3, 4 and 5 years
All revascularizations
Time frame: 5 year
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Leeuwarden, Netherlands
Major adverse cardiac events
All-cause mortality, any MI, any repeat revascularization
Time frame: 30 days, and 1, 2, 3, 4 and 5 years
All cause mortality
Time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Myocardial Infarction
Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI
Time frame: 30 days, 1, 2, 3, 4 and 5 years
Target Lesion Revascularization (TLR)
Time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Target Vessel Revascularization (TVR)
Time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Non-Target Vessel Revascularization (NTVR)
Time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Scaffold/Stent Thrombosis
acute, subacute, late/definite and probable
Time frame: 30 days, 1, 2, 3, 4 and 5 years
Seattle Angina Questionnaire (SAQ)
Time frame: 1 year and 2 years
Quality of Life Questionnaire (QOL)
Time frame: 1 year and 2 years